Trial Outcomes & Findings for A Study of the Safety and Efficacy of DFD-03 Lotion in the Treatment of Acne Vulgaris for 12 Weeks (NCT NCT03292640)
NCT ID: NCT03292640
Last Updated: 2021-03-01
Results Overview
Change in inflammatory lesion counts on the face from baseline to Week 12
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
547 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2021-03-01
Participant Flow
Participant milestones
| Measure |
DFD-03 Lotion (0.1% Tazarotene)
DFD-03 (0.1% tazarotene) Lotion: Subjects will apply a quarter (U.S coin) size amount of the study product all over the moistened face and rub it into the skin until foamy. Care should be taken to avoid the areas around the eyes, mouth, and nostrils. After a short time, the subject will rinse off the product by thoroughly rinsing with warm water. This procedure will be followed twice daily, in the morning and at bedtime, approximately 12 hours apart.
|
DFD-03 Vehicle (0% Tazarotene)
DFD-03 (0% tazarotene) Lotion (Placebo): Subjects will apply a quarter (U.S coin) size amount of the study product all over the moistened face and rub it into the skin until foamy. Care should be taken to avoid the areas around the eyes, mouth, and nostrils. After a short time, the subject will rinse off the product by thoroughly rinsing with warm water. This procedure will be followed twice daily, in the morning and at bedtime, approximately 12 hours apart.
|
|---|---|---|
|
Overall Study
STARTED
|
275
|
272
|
|
Overall Study
COMPLETED
|
214
|
230
|
|
Overall Study
NOT COMPLETED
|
61
|
42
|
Reasons for withdrawal
| Measure |
DFD-03 Lotion (0.1% Tazarotene)
DFD-03 (0.1% tazarotene) Lotion: Subjects will apply a quarter (U.S coin) size amount of the study product all over the moistened face and rub it into the skin until foamy. Care should be taken to avoid the areas around the eyes, mouth, and nostrils. After a short time, the subject will rinse off the product by thoroughly rinsing with warm water. This procedure will be followed twice daily, in the morning and at bedtime, approximately 12 hours apart.
|
DFD-03 Vehicle (0% Tazarotene)
DFD-03 (0% tazarotene) Lotion (Placebo): Subjects will apply a quarter (U.S coin) size amount of the study product all over the moistened face and rub it into the skin until foamy. Care should be taken to avoid the areas around the eyes, mouth, and nostrils. After a short time, the subject will rinse off the product by thoroughly rinsing with warm water. This procedure will be followed twice daily, in the morning and at bedtime, approximately 12 hours apart.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
17
|
16
|
|
Overall Study
Adverse Event
|
20
|
2
|
|
Overall Study
Lost to Follow-up
|
24
|
24
|
Baseline Characteristics
A Study of the Safety and Efficacy of DFD-03 Lotion in the Treatment of Acne Vulgaris for 12 Weeks
Baseline characteristics by cohort
| Measure |
DFD-03 Lotion (0.1% Tazarotene)
n=275 Participants
DFD-03 (0.1% tazarotene) Lotion: Subjects will apply a quarter (U.S coin) size amount of the study product all over the moistened face and rub it into the skin until foamy. Care should be taken to avoid the areas around the eyes, mouth, and nostrils. After a short time, the subject will rinse off the product by thoroughly rinsing with warm water. This procedure will be followed twice daily, in the morning and at bedtime, approximately 12 hours apart.
|
DFD-03 Vehicle (0% Tazarotene)
n=272 Participants
DFD-03 (0% tazarotene) Lotion (Placebo): Subjects will apply a quarter (U.S coin) size amount of the study product all over the moistened face and rub it into the skin until foamy. Care should be taken to avoid the areas around the eyes, mouth, and nostrils. After a short time, the subject will rinse off the product by thoroughly rinsing with warm water. This procedure will be followed twice daily, in the morning and at bedtime, approximately 12 hours apart.
|
Total
n=547 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
93 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
178 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
182 Participants
n=99 Participants
|
187 Participants
n=107 Participants
|
369 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
20.7 years
STANDARD_DEVIATION 6.5 • n=99 Participants
|
21.3 years
STANDARD_DEVIATION 7.6 • n=107 Participants
|
21.0 years
STANDARD_DEVIATION 7.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
143 Participants
n=99 Participants
|
111 Participants
n=107 Participants
|
254 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
132 Participants
n=99 Participants
|
161 Participants
n=107 Participants
|
293 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
28 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
45 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
186 Participants
n=99 Participants
|
186 Participants
n=107 Participants
|
372 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
275 participants
n=99 Participants
|
272 participants
n=107 Participants
|
547 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Intent To Treat (ITT) Population - All subjects randomized and dispensed study medication.
Change in inflammatory lesion counts on the face from baseline to Week 12
Outcome measures
| Measure |
DFD-03 Lotion (0.1% Tazarotene)
n=275 Face
DFD-03 (0.1% tazarotene) Lotion: Subjects will apply a quarter (U.S coin) size amount of the study product all over the moistened face and rub it into the skin until foamy. Care should be taken to avoid the areas around the eyes, mouth, and nostrils. After a short time, the subject will rinse off the product by thoroughly rinsing with warm water. This procedure will be followed twice daily, in the morning and at bedtime, approximately 12 hours apart.
|
DFD-03 Vehicle (0% Tazarotene)
n=272 Face
DFD-03 (0% tazarotene) Lotion (Placebo): Subjects will apply a quarter (U.S coin) size amount of the study product all over the moistened face and rub it into the skin until foamy. Care should be taken to avoid the areas around the eyes, mouth, and nostrils. After a short time, the subject will rinse off the product by thoroughly rinsing with warm water. This procedure will be followed twice daily, in the morning and at bedtime, approximately 12 hours apart.
|
|---|---|---|
|
Absolute Change in the Inflammatory Lesion Counts on the Face
Baseline
|
29.4 Lesions
Standard Deviation 13.82
|
29.7 Lesions
Standard Deviation 13.27
|
|
Absolute Change in the Inflammatory Lesion Counts on the Face
Week 12
|
15.9 Lesions
Standard Deviation 12.14
|
18.2 Lesions
Standard Deviation 16.58
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Intent To Treat (ITT) Population - All subjects randomized and dispensed study medication.
IGA success at Week 12 (an IGA score of 0 (Clear) or 1 (almost clear) with at least a 2-grade reduction from baseline)
Outcome measures
| Measure |
DFD-03 Lotion (0.1% Tazarotene)
n=275 Participants
DFD-03 (0.1% tazarotene) Lotion: Subjects will apply a quarter (U.S coin) size amount of the study product all over the moistened face and rub it into the skin until foamy. Care should be taken to avoid the areas around the eyes, mouth, and nostrils. After a short time, the subject will rinse off the product by thoroughly rinsing with warm water. This procedure will be followed twice daily, in the morning and at bedtime, approximately 12 hours apart.
|
DFD-03 Vehicle (0% Tazarotene)
n=272 Participants
DFD-03 (0% tazarotene) Lotion (Placebo): Subjects will apply a quarter (U.S coin) size amount of the study product all over the moistened face and rub it into the skin until foamy. Care should be taken to avoid the areas around the eyes, mouth, and nostrils. After a short time, the subject will rinse off the product by thoroughly rinsing with warm water. This procedure will be followed twice daily, in the morning and at bedtime, approximately 12 hours apart.
|
|---|---|---|
|
Proportion of Subjects With a Clinical Response of "Success" at Week 12 for Lesions on the Face Based on IGA.
|
58 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Intent To Treat (ITT) Population - All subjects randomized and dispensed study medication
Change in non-inflammatory lesion counts on the face from baseline to Week 12 - will be analyzed using the ANCOVA model
Outcome measures
| Measure |
DFD-03 Lotion (0.1% Tazarotene)
n=275 Participants
DFD-03 (0.1% tazarotene) Lotion: Subjects will apply a quarter (U.S coin) size amount of the study product all over the moistened face and rub it into the skin until foamy. Care should be taken to avoid the areas around the eyes, mouth, and nostrils. After a short time, the subject will rinse off the product by thoroughly rinsing with warm water. This procedure will be followed twice daily, in the morning and at bedtime, approximately 12 hours apart.
|
DFD-03 Vehicle (0% Tazarotene)
n=272 Participants
DFD-03 (0% tazarotene) Lotion (Placebo): Subjects will apply a quarter (U.S coin) size amount of the study product all over the moistened face and rub it into the skin until foamy. Care should be taken to avoid the areas around the eyes, mouth, and nostrils. After a short time, the subject will rinse off the product by thoroughly rinsing with warm water. This procedure will be followed twice daily, in the morning and at bedtime, approximately 12 hours apart.
|
|---|---|---|
|
Absolute Change in the Non-inflammatory Lesion Counts on the Face
Baseline
|
44.8 Lesions
Standard Deviation 33.93
|
44.4 Lesions
Standard Deviation 27.75
|
|
Absolute Change in the Non-inflammatory Lesion Counts on the Face
Week 12
|
24.3 Lesions
Standard Deviation 18.13
|
29.7 Lesions
Standard Deviation 23.12
|
Adverse Events
DFD-03 Lotion (0.1% Tazarotene)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
DFD-03 Vehicle (0% Tazarotene)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DFD-03 Lotion (0.1% Tazarotene)
n=275 participants at risk
DFD-03 (0.1% tazarotene) Lotion was to be applied twice daily for 12 weeks
|
DFD-03 Vehicle (0% Tazarotene)
n=272 participants at risk
DFD-03 Vehicle Lotion (0% tazarotene) was to be applied twice daily for 12 weeks
|
|---|---|---|
|
Injury, poisoning and procedural complications
Auto Accident with head trauma
|
0.36%
1/275 • Number of events 1 • Adverse event data were collected from the time treatment was initiated until study product treatment was discontinued (i.e. up to 12 weeks), except for spontaneously reported SAEs, which were to be reported up to 30 days after discontinuing study product use.
|
0.00%
0/272 • Adverse event data were collected from the time treatment was initiated until study product treatment was discontinued (i.e. up to 12 weeks), except for spontaneously reported SAEs, which were to be reported up to 30 days after discontinuing study product use.
|
|
Gastrointestinal disorders
Stomach Ulcer
|
0.36%
1/275 • Number of events 1 • Adverse event data were collected from the time treatment was initiated until study product treatment was discontinued (i.e. up to 12 weeks), except for spontaneously reported SAEs, which were to be reported up to 30 days after discontinuing study product use.
|
0.00%
0/272 • Adverse event data were collected from the time treatment was initiated until study product treatment was discontinued (i.e. up to 12 weeks), except for spontaneously reported SAEs, which were to be reported up to 30 days after discontinuing study product use.
|
Other adverse events
Adverse event data not reported
Additional Information
Srinivas Sidgiddi, Senior Director, Clinical Development
Dr. Reddy's Laboratoris, Inc
Phone: 9084585362
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place