Trial Outcomes & Findings for Study to Compare 2 Botulinum Type A Toxins in the Treatment of Glabellar Frown Lines (NCT NCT04763265)
NCT ID: NCT04763265
Last Updated: 2025-03-18
Results Overview
The primary endpoint is the percentage of subjects among BoNT/A-DP and Botox Cosmetic groups with a Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 1 points in FWS score (at maximum frown) at week 4 visit (of the first treatment cycle) relative to baseline (responders), based on both the investigators' and the subjects' in-clinic assessments. Thus, the primary endpoint is a composite endpoint comprising investigator and subject assessments of treatment effectiveness. FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles. Subjects with missing in-clinic assessments with the FWS at Baseline or Week 4 were assigned as non-responders.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
208 participants
Primary outcome timeframe
week 4
Results posted on
2025-03-18
Participant Flow
Of 208 enrolled participants, 200 met inclusion criteria and were randomized to treatment.
Participant milestones
| Measure |
Group A (n=100): BoNT/A-DP (20 U, 0.5 mL)
The injection sites should be prepared according to standard clinical procedures..
A volume of 0.5 mL of the properly reconstituted BoNT/A-DP should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A "BoNT/A-DP": To assess the efficacy of treatment with BoNT/A-DP in reducing the severity of glabellar frown lines at maximum frown.
|
Group B (n=100): Botox Cosmetic (20 U, 0.5 mL)
The injection sites should be prepared according to standard clinical procedures.
A volume of 0.5 mL of the properly reconstituted Botox Cosmetic should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A "Botox Cosmetics": To assess the efficacy of treatment with Botox Cosmetics in reducing the severity of glabellar frown lines at maximum frown.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
97
|
95
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
Group A (n=100): BoNT/A-DP (20 U, 0.5 mL)
The injection sites should be prepared according to standard clinical procedures..
A volume of 0.5 mL of the properly reconstituted BoNT/A-DP should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A "BoNT/A-DP": To assess the efficacy of treatment with BoNT/A-DP in reducing the severity of glabellar frown lines at maximum frown.
|
Group B (n=100): Botox Cosmetic (20 U, 0.5 mL)
The injection sites should be prepared according to standard clinical procedures.
A volume of 0.5 mL of the properly reconstituted Botox Cosmetic should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A "Botox Cosmetics": To assess the efficacy of treatment with Botox Cosmetics in reducing the severity of glabellar frown lines at maximum frown.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Study to Compare 2 Botulinum Type A Toxins in the Treatment of Glabellar Frown Lines
Baseline characteristics by cohort
| Measure |
Group A: BoNT/A-DP (20 U, 0.5 mL)
n=99 Participants
The injection sites should be prepared according to standard clinical procedures..
A volume of 0.5 mL of the properly reconstituted BoNT/A-DP should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A "BoNT/A-DP": To assess the efficacy of treatment with BoNT/A-DP in reducing the severity of glabellar frown lines at maximum frown.
|
Group B: Botox Cosmetic (20 U, 0.5 mL)
n=100 Participants
The injection sites should be prepared according to standard clinical procedures.
A volume of 0.5 mL of the properly reconstituted Botox Cosmetic should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A "Botox Cosmetics": To assess the efficacy of treatment with Botox Cosmetics in reducing the severity of glabellar frown lines at maximum frown.
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Region of Enrollment
Austria
|
22 participants
n=99 Participants
|
23 participants
n=107 Participants
|
45 participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
87 Participants
n=99 Participants
|
90 Participants
n=107 Participants
|
177 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
39 participants
n=99 Participants
|
34 participants
n=107 Participants
|
73 participants
n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
90 Participants
n=99 Participants
|
92 Participants
n=107 Participants
|
182 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Age, Continuous
|
48.9 years
STANDARD_DEVIATION 11.36 • n=99 Participants
|
48.1 years
STANDARD_DEVIATION 12.04 • n=107 Participants
|
48.5 years
STANDARD_DEVIATION 11.69 • n=206 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
172 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
81 Participants
n=99 Participants
|
79 Participants
n=107 Participants
|
160 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=99 Participants
|
43 participants
n=107 Participants
|
81 participants
n=206 Participants
|
|
Fitzpatrick Skintype
Type I
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Fitzpatrick Skintype
Type II
|
33 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Fitzpatrick Skintype
Type III
|
31 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Fitzpatrick Skintype
Type IV
|
27 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Fitzpatrick Skintype
Type V
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Fitzpatrick Skintype
Type VI
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: week 4Population: The population consists of all randomized subjects who had a baseline visit and at least one post-dose in-clinic assessment with the 4-point Facial Wrinkle Scale by either the investigator or the subject at Weeks 1, 2, or 4.
The primary endpoint is the percentage of subjects among BoNT/A-DP and Botox Cosmetic groups with a Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 1 points in FWS score (at maximum frown) at week 4 visit (of the first treatment cycle) relative to baseline (responders), based on both the investigators' and the subjects' in-clinic assessments. Thus, the primary endpoint is a composite endpoint comprising investigator and subject assessments of treatment effectiveness. FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles. Subjects with missing in-clinic assessments with the FWS at Baseline or Week 4 were assigned as non-responders.
Outcome measures
| Measure |
Group A: BoNT/A-DP (20 U, 0.5 mL)
n=99 Participants
The injection sites should be prepared according to standard clinical procedures..
A volume of 0.5 mL of the properly reconstituted BoNT/A-DP should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A "BoNT/A-DP": To assess the efficacy of treatment with BoNT/A-DP in reducing the severity of glabellar frown lines at maximum frown.
|
Group B: Botox Cosmetic (20 U, 0.5 mL)
n=100 Participants
The injection sites should be prepared according to standard clinical procedures.
A volume of 0.5 mL of the properly reconstituted Botox Cosmetic should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A "Botox Cosmetics": To assess the efficacy of treatment with Botox Cosmetics in reducing the severity of glabellar frown lines at maximum frown.
|
|---|---|---|
|
Facial Wrinkle Scale (FWS) Score of 0 or 1 and an Improvement of ≥ 1 Points in FWS Score (at Maximum Frown) at Week 4 Visit Relative to Baseline, Based on Both the Investigators´ and the Subjects´ In-clinic Assessments.
Responder based on Investigator's In-clinic Assessment
|
95 Participants
|
97 Participants
|
|
Facial Wrinkle Scale (FWS) Score of 0 or 1 and an Improvement of ≥ 1 Points in FWS Score (at Maximum Frown) at Week 4 Visit Relative to Baseline, Based on Both the Investigators´ and the Subjects´ In-clinic Assessments.
Responder based on Subject's In-clinic Assessment
|
81 Participants
|
88 Participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 8, 12 and 16Population: The population consists of all randomized subjects who had a baseline visit and at least one post-dose in-clinic assessment with the 4-point Facial Wrinkle Scale by either the investigator or the subject at Weeks 1, 2, or 4.
The percentage of responders based on the independent investigator assessment and subject assessment at Weeks 1, 2, 8, 12 and 16 after a single treatment with BoNT/A-DP and compared to a single treatment of Botox Cosmetic. Responder is defined as having a Facial Wrinkle Scale (FWS) score of 0 or 1 and at least 1 point reduction in FWS score at maximum frown over Baseline, on the 4-point FWS. FWS scores are ranked as 0 (no facial wrinkles), 1 (mild facial wrinkles), 2 (moderate facial wrinkles) and 3 (severe facial wrinkles). Subjects with missing in-clinic assessments with the FWS at Baseline or the respective visit were assigned as non-responders.
Outcome measures
| Measure |
Group A: BoNT/A-DP (20 U, 0.5 mL)
n=99 Participants
The injection sites should be prepared according to standard clinical procedures..
A volume of 0.5 mL of the properly reconstituted BoNT/A-DP should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A "BoNT/A-DP": To assess the efficacy of treatment with BoNT/A-DP in reducing the severity of glabellar frown lines at maximum frown.
|
Group B: Botox Cosmetic (20 U, 0.5 mL)
n=100 Participants
The injection sites should be prepared according to standard clinical procedures.
A volume of 0.5 mL of the properly reconstituted Botox Cosmetic should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A "Botox Cosmetics": To assess the efficacy of treatment with Botox Cosmetics in reducing the severity of glabellar frown lines at maximum frown.
|
|---|---|---|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16
Responder Rate at Week 1 based on Investigator's In-clinic Assessment
|
93 Participants
|
90 Participants
|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16
Responder Rate at Week 2 based on Investigator's In-clinic Assessment
|
93 Participants
|
95 Participants
|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16
Responder Rate at Week 8 based on Subject's In-clinic Assessment
|
60 Participants
|
76 Participants
|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16
Responder Rate at Week 12 based on Investigator's In-clinic Assessment
|
66 Participants
|
78 Participants
|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16
Responder Rate at Week 12 based on Subject's In-clinic Assessment
|
43 Participants
|
56 Participants
|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16
Responder Rate at Week 16 based on Investigator's In-clinic Assessment
|
47 Participants
|
61 Participants
|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16
Responder Rate at Week 1 based on Subject's In-clinic Assessment
|
80 Participants
|
83 Participants
|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16
Responder Rate at Week 2 based on Subject's In-clinic Assessment
|
83 Participants
|
91 Participants
|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16
Responder Rate at Week 8 based on Investigator's In-clinic Assessment
|
84 Participants
|
89 Participants
|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16
Responder Rate at Week 16 based on Subject's In-clinic Assessment
|
35 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 8, 12 and 16Population: The population consists of all randomized subjects who had a baseline visit and at least one post-dose in-clinic assessment with the 4-point Facial Wrinkle Scale by either the investigator or the subject at Weeks 1, 2, or 4.
The percentage of responders based on the independent investigator assessment and subject assessment at Weeks 1, 2, 4, 8, 12 and 16 after a single treatment with BoNT/A-DP and compared to a single treatment of Botox Cosmetic. Responder is defined as having a Facial Wrinkle Scale (FWS) score of 0 or 1 and at least 2 point reduction in FWS score at maximum frown over Baseline, on the 4-point FWS. FWS scores are ranked as 0 (no facial wrinkles), 1 (mild facial wrinkles), 2 (moderate facial wrinkles) and 3 (severe facial wrinkles). Subjects with missing in-clinic assessments with the FWS at Baseline or the respective visit were assigned as non-responders.
Outcome measures
| Measure |
Group A: BoNT/A-DP (20 U, 0.5 mL)
n=99 Participants
The injection sites should be prepared according to standard clinical procedures..
A volume of 0.5 mL of the properly reconstituted BoNT/A-DP should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A "BoNT/A-DP": To assess the efficacy of treatment with BoNT/A-DP in reducing the severity of glabellar frown lines at maximum frown.
|
Group B: Botox Cosmetic (20 U, 0.5 mL)
n=100 Participants
The injection sites should be prepared according to standard clinical procedures.
A volume of 0.5 mL of the properly reconstituted Botox Cosmetic should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A "Botox Cosmetics": To assess the efficacy of treatment with Botox Cosmetics in reducing the severity of glabellar frown lines at maximum frown.
|
|---|---|---|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16
Responder Rate at Week 4 based on Investigator's In-clinic Assessment
|
82 Participants
|
88 Participants
|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16
Responder Rate at Week 8 based on Subject's In-clinic Assessment
|
44 Participants
|
65 Participants
|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16
Responder Rate at Week 16 based on Investigator's In-clinic Assessment
|
22 Participants
|
33 Participants
|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16
Responder Rate at Week 16 based on Subject's In-clinic Assessment
|
18 Participants
|
32 Participants
|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16
Responder Rate at Week 1 based on Investigator's In-clinic Assessment
|
80 Participants
|
79 Participants
|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16
Responder Rate at Week 1 based on Subject's In-clinic Assessment
|
68 Participants
|
72 Participants
|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16
Responder Rate at Week 2 based on Investigator's In-clinic Assessment
|
83 Participants
|
86 Participants
|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16
Responder Rate at Week 2 based on Subject's In-clinic Assessment
|
75 Participants
|
83 Participants
|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16
Responder Rate at Week 4 based on Subject's In-clinic Assessment
|
67 Participants
|
81 Participants
|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16
Responder Rate at Week 8 based on Investigator's In-clinic Assessment
|
64 Participants
|
70 Participants
|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16
Responder Rate at Week 12 based on Investigator's In-clinic Assessment
|
37 Participants
|
52 Participants
|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16
Responder Rate at Week 12 based on Subject's In-clinic Assessment
|
27 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 8, 12 and 16Population: The population consists of all randomized subjects who had a baseline visit and at least one post-dose in-clinic assessment with the 4-point Facial Wrinkle Scale by either the investigator or the subject at Weeks 1, 2, or 4.
The percentage of responders based on the independent investigator assessment and subject assessment at Weeks 1, 2, 4, 8, 12 and 16 after a single treatment with BoNT/A-DP and compared to a single treatment of Botox Cosmetic. Responder is defined as having a Facial Wrinkle Scale (FWS) score of 0 or 1 and at least 1 point reduction in FWS score at rest over Baseline, on the 4-point FWS. FWS scores are ranked as 0 (no facial wrinkles), 1 (mild facial wrinkles), 2 (moderate facial wrinkles) and 3 (severe facial wrinkles). Subjects with missing in-clinic assessments with the FWS at Baseline or the respective visit were assigned as non-responders.
Outcome measures
| Measure |
Group A: BoNT/A-DP (20 U, 0.5 mL)
n=99 Participants
The injection sites should be prepared according to standard clinical procedures..
A volume of 0.5 mL of the properly reconstituted BoNT/A-DP should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A "BoNT/A-DP": To assess the efficacy of treatment with BoNT/A-DP in reducing the severity of glabellar frown lines at maximum frown.
|
Group B: Botox Cosmetic (20 U, 0.5 mL)
n=100 Participants
The injection sites should be prepared according to standard clinical procedures.
A volume of 0.5 mL of the properly reconstituted Botox Cosmetic should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A "Botox Cosmetics": To assess the efficacy of treatment with Botox Cosmetics in reducing the severity of glabellar frown lines at maximum frown.
|
|---|---|---|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16
Responder Rate at Week 1 based on Investigator's In-clinic Assessment
|
57 Participants
|
53 Participants
|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16
Responder Rate at Week 1 based on Subject's In-clinic Assessment
|
58 Participants
|
58 Participants
|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16
Responder Rate at Week 2 based on Investigator's In-clinic Assessment
|
65 Participants
|
64 Participants
|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16
Responder Rate at Week 2 based on Subject's In-clinic Assessment
|
70 Participants
|
64 Participants
|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16
Responder Rate at Week 4 based on Investigator's In-clinic Assessment
|
67 Participants
|
68 Participants
|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16
Responder Rate at Week 4 based on Subject's In-clinic Assessment
|
68 Participants
|
70 Participants
|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16
Responder Rate at Week 8 based on Investigator's In-clinic Assessment
|
63 Participants
|
62 Participants
|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16
Responder Rate at Week 8 based on Subject's In-clinic Assessment
|
57 Participants
|
60 Participants
|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16
Responder Rate at Week 12 based on Investigator's In-clinic Assessment
|
58 Participants
|
53 Participants
|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16
Responder Rate at Week 12 based on Subject's In-clinic Assessment
|
45 Participants
|
48 Participants
|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16
Responder Rate at Week 16 based on Investigator's In-clinic Assessment
|
45 Participants
|
52 Participants
|
|
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16
Responder Rate at Week 16 based on Subject's In-clinic Assessment
|
36 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: From treatment at Day 0 to Week 4Population: The population consists of all randomized subjects who had a baseline visit and at least one post-dose in-clinic assessment with the 4-point Facial Wrinkle Scale by either the investigator or the subject at Weeks 1, 2, or 4.
Time to onset of effect in days, as measured at Weeks 1, 2, and 4, based on independent investigator and subject assessments after a single treatment with BoNT/A-DP and compared to Botox Cosmetic. Onset of effect is defined as at least 1 point improvement in Glabellar Line Scale - Investigator (GLS-I) and Glabellar Line Scale - Subject (GLS-S) score relative to Baseline at maximum frown in glabellar lines. GLS-I and GLS-S both use the same 4-point scale, ranked as 0 (No lines/minimal lines), 1 (Mild lines), 2 (Moderate lines) and 3 (Severe lines).
Outcome measures
| Measure |
Group A: BoNT/A-DP (20 U, 0.5 mL)
n=99 Participants
The injection sites should be prepared according to standard clinical procedures..
A volume of 0.5 mL of the properly reconstituted BoNT/A-DP should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A "BoNT/A-DP": To assess the efficacy of treatment with BoNT/A-DP in reducing the severity of glabellar frown lines at maximum frown.
|
Group B: Botox Cosmetic (20 U, 0.5 mL)
n=100 Participants
The injection sites should be prepared according to standard clinical procedures.
A volume of 0.5 mL of the properly reconstituted Botox Cosmetic should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A "Botox Cosmetics": To assess the efficacy of treatment with Botox Cosmetics in reducing the severity of glabellar frown lines at maximum frown.
|
|---|---|---|
|
Time to Onset of Effect Based on Independent Investigator Assessment and Subject Assessment
|
8.0 Days
Interval 7.0 to 9.0
|
8.0 Days
Interval 7.5 to 8.0
|
SECONDARY outcome
Timeframe: 16 WeeksPopulation: The population consists of all randomized subjects who had a baseline visit and at least one post-dose in-clinic assessment with the 4-point Facial Wrinkle Scale by either the investigator or the subject at Weeks 1, 2, or 4.
For subjects who are responders at week 4, duration of effect in days is assessed based on independent investigator and subject assessments after a single treatment with BoNT/A-DP and compared to Botox Cosmetic. Responder is defined as having a Facial Wrinkle Scale (FWS) score of 0 or 1 and at least 1 point reduction in FWS score at maximum frown over Baseline, on the 4-point FWS. FWS scores are ranked as 0 (no facial wrinkles), 1 (mild facial wrinkles), 2 (moderate facial wrinkles) and 3 (severe facial wrinkles). Effect is deemed to be lost when scores return to Baseline or worse values. Duration of effect is defined as (the date that loss of response occurred) - (date of single study treatment ) + 1.
Outcome measures
| Measure |
Group A: BoNT/A-DP (20 U, 0.5 mL)
n=99 Participants
The injection sites should be prepared according to standard clinical procedures..
A volume of 0.5 mL of the properly reconstituted BoNT/A-DP should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A "BoNT/A-DP": To assess the efficacy of treatment with BoNT/A-DP in reducing the severity of glabellar frown lines at maximum frown.
|
Group B: Botox Cosmetic (20 U, 0.5 mL)
n=100 Participants
The injection sites should be prepared according to standard clinical procedures.
A volume of 0.5 mL of the properly reconstituted Botox Cosmetic should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A "Botox Cosmetics": To assess the efficacy of treatment with Botox Cosmetics in reducing the severity of glabellar frown lines at maximum frown.
|
|---|---|---|
|
Duration of Effect Based on Independent Investigator Assessment and Subject Assessment
Duration of effect for responders at Week 4 based on Subject's in-clinic assessment
|
116 Days
Interval 114.0 to 121.0
|
NA Days
Interval 117.0 to
Since more than 50% of subjects were still responders at Week 16, it was not possible to calculate the median or the upper limit of the 95% Confidence Interval for the median.
|
|
Duration of Effect Based on Independent Investigator Assessment and Subject Assessment
Duration of effect for responders at Week 4 based on Investigator's in-clinic assessment
|
132 Days
Interval 117.0 to 132.0
|
NA Days
Interval 119.0 to
Since more than 50% of subjects were still responders at Week 16, it was not possible to calculate the median or the upper limit of the 95% Confidence Interval for the median.
|
SECONDARY outcome
Timeframe: Weeks 4, 12 and 16Population: The population consists of all randomized subjects who had a baseline visit and at least one post-dose in-clinic assessment with the 4-point Facial Wrinkle Scale by either the investigator or the subject at Weeks 1, 2, or 4.
Summary of FACE-Q satisfaction with outcome scale based on subject assessment at weeks 4, 12 and 16 after a single treatment and compared to Botox Cosmetic. The FACE-Q Satisfaction with Outcome scale is a patient-reported outcome measure designed to assess a patient's satisfaction with the results of a facial aesthetic procedure. This scale comprises six items, each with four response options: "definitely agree," "somewhat agree," "somewhat disagree," and "definitely disagree."
Outcome measures
| Measure |
Group A: BoNT/A-DP (20 U, 0.5 mL)
n=99 Participants
The injection sites should be prepared according to standard clinical procedures..
A volume of 0.5 mL of the properly reconstituted BoNT/A-DP should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A "BoNT/A-DP": To assess the efficacy of treatment with BoNT/A-DP in reducing the severity of glabellar frown lines at maximum frown.
|
Group B: Botox Cosmetic (20 U, 0.5 mL)
n=100 Participants
The injection sites should be prepared according to standard clinical procedures.
A volume of 0.5 mL of the properly reconstituted Botox Cosmetic should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A "Botox Cosmetics": To assess the efficacy of treatment with Botox Cosmetics in reducing the severity of glabellar frown lines at maximum frown.
|
|---|---|---|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 4 - expected · Definitely agree
|
57 Participants
|
59 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 4 - pleased · Definitely disagree
|
2 Participants
|
0 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 4 - pleased · Somewhat disagree
|
3 Participants
|
3 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 4 - pleased · Somewhat agree
|
17 Participants
|
12 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 4 - pleased · Definitely agree
|
77 Participants
|
84 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 4 - pleased · Missing
|
0 Participants
|
1 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 4 - expected · Definitely disagree
|
4 Participants
|
0 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 4 - expected · Somewhat disagree
|
5 Participants
|
6 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 4 - expected · Somewhat agree
|
33 Participants
|
34 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 4 - expected · Missing
|
0 Participants
|
1 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 4 - great · Definitely disagree
|
2 Participants
|
1 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 4 - great · Somewhat disagree
|
8 Participants
|
7 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 4 - great · Somewhat agree
|
23 Participants
|
15 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 4 - great · Definitely agree
|
66 Participants
|
76 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 4 - great · Missing
|
0 Participants
|
1 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 4 - look in the mirror · Definitely disagree
|
1 Participants
|
1 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 4 - look in the mirror · Somewhat disagree
|
12 Participants
|
8 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 4 - look in the mirror · Somewhat agree
|
31 Participants
|
30 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 4 - look in the mirror · Definitely agree
|
55 Participants
|
60 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 4 - look in the mirror · Missing
|
0 Participants
|
1 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 4 - fantastic · Definitely disagree
|
4 Participants
|
3 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 4 - fantastic · Somewhat disagree
|
13 Participants
|
11 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 4 - fantastic · Somewhat agree
|
25 Participants
|
18 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 4 - fantastic · Definitely agree
|
57 Participants
|
67 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 4 - fantastic · Missing
|
0 Participants
|
1 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 4 - miraculous · Definitely disagree
|
11 Participants
|
4 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 4 - miraculous · Somewhat disagree
|
16 Participants
|
19 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 4 - miraculous · Somewhat agree
|
32 Participants
|
27 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 4 - miraculous · Definitely agree
|
40 Participants
|
49 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 4 - miraculous · Missing
|
0 Participants
|
1 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 12 - pleased · Definitely disagree
|
10 Participants
|
3 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 12 - pleased · Somewhat disagree
|
6 Participants
|
7 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 12 - pleased · Somewhat agree
|
28 Participants
|
24 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 12 - pleased · Definitely agree
|
50 Participants
|
60 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 12 - pleased · Missing
|
5 Participants
|
6 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 12 - expected · Definitely disagree
|
11 Participants
|
6 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 12 - expected · Somewhat disagree
|
11 Participants
|
9 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 12 - expected · Somewhat agree
|
29 Participants
|
33 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 12 - expected · Definitely agree
|
43 Participants
|
46 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 12 - expected · Missing
|
5 Participants
|
6 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 12 - great · Definitely disagree
|
9 Participants
|
5 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 12 - great · Somewhat disagree
|
14 Participants
|
12 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 12 - great · Somewhat agree
|
28 Participants
|
22 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 12 - great · Definitely agree
|
43 Participants
|
55 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 12 - great · Missing
|
5 Participants
|
6 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 12 - look in the mirror · Definitely disagree
|
13 Participants
|
4 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 12 - look in the mirror · Somewhat disagree
|
14 Participants
|
15 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 12 - look in the mirror · Somewhat agree
|
33 Participants
|
36 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 12 - look in the mirror · Definitely agree
|
34 Participants
|
39 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 12 - look in the mirror · Missing
|
5 Participants
|
6 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 12 - fantastic · Definitely disagree
|
12 Participants
|
7 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 12 - fantastic · Somewhat disagree
|
22 Participants
|
18 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 12 - fantastic · Somewhat agree
|
27 Participants
|
27 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 12 - fantastic · Definitely agree
|
33 Participants
|
42 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 12 - fantastic · Missing
|
5 Participants
|
6 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 12 - miraculous · Definitely disagree
|
25 Participants
|
8 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 12 - miraculous · Somewhat disagree
|
14 Participants
|
27 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 12 - miraculous · Somewhat agree
|
31 Participants
|
30 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 12 - miraculous · Definitely agree
|
24 Participants
|
29 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 12 - miraculous · Missing
|
5 Participants
|
6 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 16 - pleased · Definitely disagree
|
12 Participants
|
5 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 16 - pleased · Somewhat disagree
|
10 Participants
|
8 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 16 - pleased · Somewhat agree
|
21 Participants
|
20 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 16 - pleased · Definitely agree
|
54 Participants
|
62 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 16 - pleased · Missing
|
2 Participants
|
5 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 16 - expected · Definitely disagree
|
12 Participants
|
6 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 16 - expected · Somewhat disagree
|
14 Participants
|
12 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 16 - expected · Somewhat agree
|
31 Participants
|
31 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 16 - expected · Definitely agree
|
40 Participants
|
46 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 16 - expected · Missing
|
2 Participants
|
5 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 16 - great · Definitely disagree
|
10 Participants
|
8 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 16 - great · Somewhat disagree
|
20 Participants
|
13 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 16 - great · Somewhat agree
|
20 Participants
|
18 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 16 - great · Definitely agree
|
47 Participants
|
56 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 16 - great · Missing
|
2 Participants
|
5 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 16 - look in the mirror · Definitely disagree
|
12 Participants
|
11 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 16 - look in the mirror · Somewhat disagree
|
20 Participants
|
15 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 16 - look in the mirror · Somewhat agree
|
29 Participants
|
30 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 16 - look in the mirror · Definitely agree
|
36 Participants
|
39 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 16 - look in the mirror · Missing
|
2 Participants
|
5 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 16 - fantastic · Definitely disagree
|
17 Participants
|
10 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 16 - fantastic · Somewhat disagree
|
19 Participants
|
17 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 16 - fantastic · Somewhat agree
|
24 Participants
|
21 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 16 - fantastic · Definitely agree
|
37 Participants
|
47 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 16 - fantastic · Missing
|
2 Participants
|
5 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 16 - miraculous · Definitely disagree
|
26 Participants
|
14 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 16 - miraculous · Somewhat disagree
|
14 Participants
|
20 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 16 - miraculous · Somewhat agree
|
35 Participants
|
33 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 16 - miraculous · Definitely agree
|
22 Participants
|
28 Participants
|
|
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Week 16 - miraculous · Missing
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: through study completion, an average of 16 weeksPopulation: The population consists of all subjects who received at least one injection with the study medication.
Frequency, seriousness and severity of treatment-emergent adverse events (TEAEs), serious AEs (SAEs) and AEs of special interest (AESIs), as well as causal relationship to the study medication and the study procedure, during the entire study period. A subject with multiple occurrences of an adverse event is counted only once within the worst severity category.
Outcome measures
| Measure |
Group A: BoNT/A-DP (20 U, 0.5 mL)
n=100 Participants
The injection sites should be prepared according to standard clinical procedures..
A volume of 0.5 mL of the properly reconstituted BoNT/A-DP should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A "BoNT/A-DP": To assess the efficacy of treatment with BoNT/A-DP in reducing the severity of glabellar frown lines at maximum frown.
|
Group B: Botox Cosmetic (20 U, 0.5 mL)
n=100 Participants
The injection sites should be prepared according to standard clinical procedures.
A volume of 0.5 mL of the properly reconstituted Botox Cosmetic should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A "Botox Cosmetics": To assess the efficacy of treatment with Botox Cosmetics in reducing the severity of glabellar frown lines at maximum frown.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs)
Subjects with any treatment-emergent adverse events
|
25 Participants
|
22 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs)
Subjects with any serious treatment-emergent adverse events
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs)
Subjects with any treatment-emergent adverse events of special interest
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs)
Subjects with any severe treatment-emergent adverse events
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs)
Subjects with any moderate treatment-emergent adverse events
|
5 Participants
|
4 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs)
Subjects with any mild treatment-emergent adverse events
|
20 Participants
|
18 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs)
Subjects with any treatment-emergent adverse events related to study medication
|
4 Participants
|
3 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs)
Subjects with any treatment-emergent adverse events related to study procedure
|
6 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Weeks 1, 4, 12, and 16Population: The population consists of all subjects who received at least one injection with the study medication. Only subjects with available data at the respective visit were analyzed.
Summary of change from baseline in diastolic/systolic blood pressure at weeks 1, 4, 12 and 16 after a single treatment and compared to Botox Cosmetic.
Outcome measures
| Measure |
Group A: BoNT/A-DP (20 U, 0.5 mL)
n=100 Participants
The injection sites should be prepared according to standard clinical procedures..
A volume of 0.5 mL of the properly reconstituted BoNT/A-DP should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A "BoNT/A-DP": To assess the efficacy of treatment with BoNT/A-DP in reducing the severity of glabellar frown lines at maximum frown.
|
Group B: Botox Cosmetic (20 U, 0.5 mL)
n=100 Participants
The injection sites should be prepared according to standard clinical procedures.
A volume of 0.5 mL of the properly reconstituted Botox Cosmetic should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A "Botox Cosmetics": To assess the efficacy of treatment with Botox Cosmetics in reducing the severity of glabellar frown lines at maximum frown.
|
|---|---|---|
|
Change From Baseline in Blood Pressure at Weeks 1, 4, 12 and 16
Diastolic Blood Pressure (mmHg) - Week 1 - Change from Baseline
|
0.9 millimeters of mercury
Standard Deviation 8.48
|
-1.9 millimeters of mercury
Standard Deviation 8.50
|
|
Change From Baseline in Blood Pressure at Weeks 1, 4, 12 and 16
Diastolic Blood Pressure (mmHg) - Week 4 - Change from Baseline
|
0.1 millimeters of mercury
Standard Deviation 8.29
|
-1.9 millimeters of mercury
Standard Deviation 8.80
|
|
Change From Baseline in Blood Pressure at Weeks 1, 4, 12 and 16
Diastolic Blood Pressure (mmHg) - Week 12 - Change from Baseline
|
-0.1 millimeters of mercury
Standard Deviation 9.64
|
-1.2 millimeters of mercury
Standard Deviation 10.19
|
|
Change From Baseline in Blood Pressure at Weeks 1, 4, 12 and 16
Diastolic Blood Pressure (mmHg) - Week 16 - Change from Baseline
|
1.0 millimeters of mercury
Standard Deviation 9.30
|
-1.6 millimeters of mercury
Standard Deviation 10.85
|
|
Change From Baseline in Blood Pressure at Weeks 1, 4, 12 and 16
Systolic Blood Pressure (mmHg) - Week 1 - Change from Baseline
|
0.2 millimeters of mercury
Standard Deviation 10.84
|
-2.4 millimeters of mercury
Standard Deviation 12.29
|
|
Change From Baseline in Blood Pressure at Weeks 1, 4, 12 and 16
Systolic Blood Pressure (mmHg) - Week 4 - Change from Baseline
|
0.3 millimeters of mercury
Standard Deviation 11.44
|
-0.9 millimeters of mercury
Standard Deviation 12.78
|
|
Change From Baseline in Blood Pressure at Weeks 1, 4, 12 and 16
Systolic Blood Pressure (mmHg) - Week 12 - Change from Baseline
|
0.6 millimeters of mercury
Standard Deviation 11.79
|
-1.3 millimeters of mercury
Standard Deviation 14.77
|
|
Change From Baseline in Blood Pressure at Weeks 1, 4, 12 and 16
Systolic Blood Pressure (mmHg) - Week 16 - Change from Baseline
|
1.5 millimeters of mercury
Standard Deviation 12.30
|
-1.5 millimeters of mercury
Standard Deviation 15.52
|
SECONDARY outcome
Timeframe: Weeks 1, 4, 12, and 16Population: The population consists of all subjects who received at least one injection with the study medication. Only subjects with available data at the respective visit were analyzed.
Summary of change from baseline in pulse rate at weeks 1, 4, 12 and 16 after a single treatment and compared to Botox Cosmetic.
Outcome measures
| Measure |
Group A: BoNT/A-DP (20 U, 0.5 mL)
n=100 Participants
The injection sites should be prepared according to standard clinical procedures..
A volume of 0.5 mL of the properly reconstituted BoNT/A-DP should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A "BoNT/A-DP": To assess the efficacy of treatment with BoNT/A-DP in reducing the severity of glabellar frown lines at maximum frown.
|
Group B: Botox Cosmetic (20 U, 0.5 mL)
n=100 Participants
The injection sites should be prepared according to standard clinical procedures.
A volume of 0.5 mL of the properly reconstituted Botox Cosmetic should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A "Botox Cosmetics": To assess the efficacy of treatment with Botox Cosmetics in reducing the severity of glabellar frown lines at maximum frown.
|
|---|---|---|
|
Change From Baseline in Pulse Rate at Weeks 1, 4, 12 and 16
Pulse Rate (beats/min) - Week 12 - Change from Baseline
|
1.2 beats/min
Standard Deviation 11.72
|
-0.2 beats/min
Standard Deviation 11.90
|
|
Change From Baseline in Pulse Rate at Weeks 1, 4, 12 and 16
Pulse Rate (beats/min) - Week 1 - Change from Baseline
|
2.2 beats/min
Standard Deviation 10.25
|
-0.4 beats/min
Standard Deviation 9.94
|
|
Change From Baseline in Pulse Rate at Weeks 1, 4, 12 and 16
Pulse Rate (beats/min) - Week 4 - Change from Baseline
|
1.0 beats/min
Standard Deviation 11.60
|
1.6 beats/min
Standard Deviation 9.46
|
|
Change From Baseline in Pulse Rate at Weeks 1, 4, 12 and 16
Pulse Rate (beats/min) - Week 16 - Change from Baseline
|
1.9 beats/min
Standard Deviation 11.02
|
0.5 beats/min
Standard Deviation 11.31
|
Adverse Events
Group A (n=100): BoNT/A-DP (20 U, 0.5 mL)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Group B (n=100): Botox Cosmetic (20 U, 0.5 mL)
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A (n=100): BoNT/A-DP (20 U, 0.5 mL)
n=100 participants at risk
The injection sites should be prepared according to standard clinical procedures..
A volume of 0.5 mL of the properly reconstituted BoNT/A-DP should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A "BoNT/A-DP": To assess the efficacy of treatment with BoNT/A-DP in reducing the severity of glabellar frown lines at maximum frown.
|
Group B (n=100): Botox Cosmetic (20 U, 0.5 mL)
n=100 participants at risk
The injection sites should be prepared according to standard clinical procedures.
A volume of 0.5 mL of the properly reconstituted Botox Cosmetic should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A "Botox Cosmetics": To assess the efficacy of treatment with Botox Cosmetics in reducing the severity of glabellar frown lines at maximum frown.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.00%
0/100 • 16 weeks
|
1.0%
1/100 • Number of events 1 • 16 weeks
|
Other adverse events
| Measure |
Group A (n=100): BoNT/A-DP (20 U, 0.5 mL)
n=100 participants at risk
The injection sites should be prepared according to standard clinical procedures..
A volume of 0.5 mL of the properly reconstituted BoNT/A-DP should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A "BoNT/A-DP": To assess the efficacy of treatment with BoNT/A-DP in reducing the severity of glabellar frown lines at maximum frown.
|
Group B (n=100): Botox Cosmetic (20 U, 0.5 mL)
n=100 participants at risk
The injection sites should be prepared according to standard clinical procedures.
A volume of 0.5 mL of the properly reconstituted Botox Cosmetic should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A "Botox Cosmetics": To assess the efficacy of treatment with Botox Cosmetics in reducing the severity of glabellar frown lines at maximum frown.
|
|---|---|---|
|
Infections and infestations
Corona virus infection
|
2.0%
2/100 • Number of events 2 • 16 weeks
|
1.0%
1/100 • Number of events 1 • 16 weeks
|
|
Injury, poisoning and procedural complications
Muscle strain
|
2.0%
2/100 • Number of events 2 • 16 weeks
|
0.00%
0/100 • 16 weeks
|
|
Investigations
Viral test positive
|
0.00%
0/100 • 16 weeks
|
3.0%
3/100 • Number of events 3 • 16 weeks
|
|
Nervous system disorders
Headache
|
6.0%
6/100 • Number of events 6 • 16 weeks
|
10.0%
10/100 • Number of events 11 • 16 weeks
|
|
Vascular disorders
Hypertension
|
1.0%
1/100 • Number of events 1 • 16 weeks
|
2.0%
2/100 • Number of events 2 • 16 weeks
|
Additional Information
Clinical Development - Head of Clinical Operations
Croma Pharma GmbH
Phone: +43 2262 684680
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place