Trial Outcomes & Findings for Safety and Efficacy of the Full Face Applications of Variable Doses of a Commercial Botulinum Toxin Type a (Dysport®) (NCT NCT01032954)
NCT ID: NCT01032954
Last Updated: 2020-10-14
Results Overview
Facial Wrinkle Scale: 0 - none, 1 - mild; 2 - moderate; 3 - severe
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
90 participants
Primary outcome timeframe
Baseline; Week 4; Week 16; Week 20; Week 24
Results posted on
2020-10-14
Participant Flow
Participant milestones
| Measure |
125 to 170 Units of Botulinum Toxin Type A
Subjects have received the lower dose of Botulinum Toxin type A
|
171 to 210 Units of Botulinum Toxin Type A
Subjects have received the intermediate dose of Botulinum Toxin type A.
|
211 to 250 Units of Botulinum Toxin Type A
Subjects have received the higher dose of Botulinum Toxin type A.
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
30
|
|
Overall Study
COMPLETED
|
26
|
29
|
30
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of the Full Face Applications of Variable Doses of a Commercial Botulinum Toxin Type a (Dysport®)
Baseline characteristics by cohort
| Measure |
Group 1
n=30 Participants
Subjects have received the lower dose of Botulinum Toxin type A, between 125 to 170 units of Botulinum Toxin type A.
|
Group 2
n=30 Participants
Subjects have received the intermediate dose of Botulinum Toxin type A, between 171 to 210 units of Botulinum Toxin type A.
|
Group 3
n=30 Participants
Subjects have received the higher dose of Botulinum Toxin type A, between 211 to 250 units of Botulinum Toxin type A
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
90 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 9 • n=99 Participants
|
47 years
STANDARD_DEVIATION 9 • n=107 Participants
|
50 years
STANDARD_DEVIATION 9 • n=206 Participants
|
48 years
STANDARD_DEVIATION 7 • n=7 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
90 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
Brazil
|
30 participants
n=99 Participants
|
30 participants
n=107 Participants
|
30 participants
n=206 Participants
|
90 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline; Week 4; Week 16; Week 20; Week 24Population: Patients in each visit.
Facial Wrinkle Scale: 0 - none, 1 - mild; 2 - moderate; 3 - severe
Outcome measures
| Measure |
125 to 170 Units of Botulinum Toxin Type A
n=26 Participants
Subjects were treated with a total dose of 125 to 170 units of Botulinum Toxin type A on facial indications in upper, middle and lower face.
|
171 to 210 Units of Botulinum Toxin Type A
n=29 Participants
Subjects were treated with a total dose of 171 to 210 units of Botulinum Toxin type A on facial indications in upper, middle and lower face.
|
211 to 250 Units of Botulinum Toxin Type A
n=30 Participants
Subjects were treated with a total dose of 211 to 250 units of Botulinum Toxin type A on facial indications in upper, middle and lower face.
|
|---|---|---|---|
|
Wrinkles' Severity (Forehead)
Baseline
|
2.31 units on a scale
Standard Deviation 0.84
|
2.66 units on a scale
Standard Deviation 0.49
|
2.60 units on a scale
Standard Deviation 0.68
|
|
Wrinkles' Severity (Forehead)
Week 4
|
1.78 units on a scale
Standard Deviation 0.44
|
1.33 units on a scale
Standard Deviation 0.70
|
0.93 units on a scale
Standard Deviation 0.70
|
|
Wrinkles' Severity (Forehead)
Week 16
|
1.82 units on a scale
Standard Deviation 0.75
|
2.15 units on a scale
Standard Deviation 0.75
|
1.96 units on a scale
Standard Deviation 0.66
|
|
Wrinkles' Severity (Forehead)
Week 20
|
2.25 units on a scale
Standard Deviation 0.89
|
2.48 units on a scale
Standard Deviation 0.68
|
2.32 units on a scale
Standard Deviation 0.61
|
|
Wrinkles' Severity (Forehead)
Week 24
|
2.44 units on a scale
Standard Deviation 0.88
|
2.58 units on a scale
Standard Deviation 0.58
|
2.48 units on a scale
Standard Deviation 0.63
|
PRIMARY outcome
Timeframe: Baseline; Week 4; Week 16; Week 20; Week 24Population: Patients in each visit.
GLADYS study Atlas: 0 - no wrinkles, 1 - mild wrinkles; 2 - moderate wrinkles; 3 - severe wrinkles
Outcome measures
| Measure |
125 to 170 Units of Botulinum Toxin Type A
n=26 Participants
Subjects were treated with a total dose of 125 to 170 units of Botulinum Toxin type A on facial indications in upper, middle and lower face.
|
171 to 210 Units of Botulinum Toxin Type A
n=29 Participants
Subjects were treated with a total dose of 171 to 210 units of Botulinum Toxin type A on facial indications in upper, middle and lower face.
|
211 to 250 Units of Botulinum Toxin Type A
n=30 Participants
Subjects were treated with a total dose of 211 to 250 units of Botulinum Toxin type A on facial indications in upper, middle and lower face.
|
|---|---|---|---|
|
Wrinkles' Severity (Glabella)
Baseline
|
1.92 units on a scale
Standard Deviation 0.67
|
2.07 units on a scale
Standard Deviation 0.53
|
2.20 units on a scale
Standard Deviation 0.66
|
|
Wrinkles' Severity (Glabella)
Week 4
|
0.54 units on a scale
Standard Deviation 0.58
|
0.59 units on a scale
Standard Deviation 0.50
|
0.57 units on a scale
Standard Deviation 0.50
|
|
Wrinkles' Severity (Glabella)
Week 16
|
1.25 units on a scale
Standard Deviation 0.60
|
1.12 units on a scale
Standard Deviation 0.60
|
1.07 units on a scale
Standard Deviation 0.54
|
|
Wrinkles' Severity (Glabella)
Week 20
|
1.42 units on a scale
Standard Deviation 0.65
|
1.44 units on a scale
Standard Deviation 0.58
|
1.31 units on a scale
Standard Deviation 0.71
|
|
Wrinkles' Severity (Glabella)
Week 24
|
1.65 units on a scale
Standard Deviation 0.69
|
1.66 units on a scale
Standard Deviation 0.48
|
1.53 units on a scale
Standard Deviation 0.63
|
PRIMARY outcome
Timeframe: Baseline; Week 4; Week 16; Week 20; Week 24Population: Patients in each visit.
Photonumeric Atlas for the Assessment of Crow's Feet Severity: 0 - none, 1 - mild; 2 - moderate; 3 - severe
Outcome measures
| Measure |
125 to 170 Units of Botulinum Toxin Type A
n=26 Participants
Subjects were treated with a total dose of 125 to 170 units of Botulinum Toxin type A on facial indications in upper, middle and lower face.
|
171 to 210 Units of Botulinum Toxin Type A
n=29 Participants
Subjects were treated with a total dose of 171 to 210 units of Botulinum Toxin type A on facial indications in upper, middle and lower face.
|
211 to 250 Units of Botulinum Toxin Type A
n=30 Participants
Subjects were treated with a total dose of 211 to 250 units of Botulinum Toxin type A on facial indications in upper, middle and lower face.
|
|---|---|---|---|
|
Wrinkles' Severity (Periocular [Crow's Feet])
Baseline
|
2.04 units on a scale
Standard Deviation 0.72
|
2.41 units on a scale
Standard Deviation 0.57
|
2.17 units on a scale
Standard Deviation 0.79
|
|
Wrinkles' Severity (Periocular [Crow's Feet])
Week 4
|
1.04 units on a scale
Standard Deviation 0.66
|
1.21 units on a scale
Standard Deviation 0.56
|
1.27 units on a scale
Standard Deviation 0.45
|
|
Wrinkles' Severity (Periocular [Crow's Feet])
Week 16
|
1.54 units on a scale
Standard Deviation 0.59
|
1.92 units on a scale
Standard Deviation 0.49
|
1.86 units on a scale
Standard Deviation 0.71
|
|
Wrinkles' Severity (Periocular [Crow's Feet])
Week 20
|
1.67 units on a scale
Standard Deviation 0.70
|
2.12 units on a scale
Standard Deviation 0.44
|
2.10 units on a scale
Standard Deviation 0.41
|
|
Wrinkles' Severity (Periocular [Crow's Feet])
Week 24
|
1.88 units on a scale
Standard Deviation 0.59
|
2.10 units on a scale
Standard Deviation 0.41
|
2.33 units on a scale
Standard Deviation 0.55
|
Adverse Events
125 to 170 Units of Botulinum Toxin Type A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
171 to 210 Units of Botulinum Toxin Type A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
211 to 250 Units of Botulinum Toxin Type A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Doris Hexsel
Brazilian Center for Studies in Dermatology
Phone: 555130262633
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place