Trial Outcomes & Findings for A Study of the Safety and Efficacy of DFD-03 for the Treatment of Acne Vulgaris (NCT NCT03290027)
NCT ID: NCT03290027
Last Updated: 2021-03-01
Results Overview
Change in inflammatory lesion counts on the face from baseline to Week 12 - will be analyzed using a two way analysis of covariance (ANCOVA) model
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
550 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2021-03-01
Participant Flow
Participant milestones
| Measure |
Active
DFD-03 (0.1% tazarotene) Lotion
DFD-03: DFD-03 Lotion
|
Vehicle
Vehicle (0% tazarotene) Lotion
Placebo Comparator: Vehicle (tazarotene 0%) Lotion
|
|---|---|---|
|
Overall Study
STARTED
|
277
|
273
|
|
Overall Study
COMPLETED
|
219
|
228
|
|
Overall Study
NOT COMPLETED
|
58
|
45
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Safety and Efficacy of DFD-03 for the Treatment of Acne Vulgaris
Baseline characteristics by cohort
| Measure |
Active
n=277 Participants
DFD-03 (0.1% tazarotene) Lotion
DFD-03: DFD-03 Lotion
|
Vehicle
n=273 Participants
Vehicle (0% tazarotene) Lotion
Placebo Comparator: Vehicle (tazarotene 0%) Lotion
|
Total
n=550 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
91 Participants
n=99 Participants
|
91 Participants
n=107 Participants
|
182 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
186 Participants
n=99 Participants
|
182 Participants
n=107 Participants
|
368 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
|
21.2 years
STANDARD_DEVIATION 7.9 • n=99 Participants
|
21.1 years
STANDARD_DEVIATION 8.0 • n=107 Participants
|
21.2 years
STANDARD_DEVIATION 7.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
145 Participants
n=99 Participants
|
158 Participants
n=107 Participants
|
303 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
132 Participants
n=99 Participants
|
115 Participants
n=107 Participants
|
247 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
109 Participants
n=99 Participants
|
105 Participants
n=107 Participants
|
214 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
168 Participants
n=99 Participants
|
168 Participants
n=107 Participants
|
336 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
21 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
|
51 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
109 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
200 Participants
n=99 Participants
|
194 Participants
n=107 Participants
|
394 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
|
13 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
277 Participants
n=99 Participants
|
273 Participants
n=107 Participants
|
550 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 - will be analyzed using a two way analysis of covariance (ANCOVA) model
Outcome measures
| Measure |
Active
n=277 Lesions
DFD-03 (0.1% tazarotene) Lotion
DFD-03: DFD-03 Lotion
|
Vehicle
n=273 Lesions
Vehicle (0% tazarotene) Lotion
Placebo Comparator: Vehicle (tazarotene 0%) Lotion
|
|---|---|---|
|
Absolute Change in the Inflammatory Lesion Counts on the Face
Baseline
|
30.1 Lesions
Standard Deviation 9.81
|
29.8 Lesions
Standard Deviation 9.13
|
|
Absolute Change in the Inflammatory Lesion Counts on the Face
Week 12
|
15.4 Lesions
Standard Deviation 11.43
|
16.9 Lesions
Standard Deviation 11.78
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: ITT Population
Change in non-inflammatory lesion counts on the face from baseline to Week 12 - will be analyzed using the same ANCOVA model
Outcome measures
| Measure |
Active
n=277 Participants
DFD-03 (0.1% tazarotene) Lotion
DFD-03: DFD-03 Lotion
|
Vehicle
n=273 Participants
Vehicle (0% tazarotene) Lotion
Placebo Comparator: Vehicle (tazarotene 0%) Lotion
|
|---|---|---|
|
Absolute Change in the Non-inflammatory Lesion Counts on the Face
Baseline
|
37.4 Lesions
Standard Deviation 14.71
|
36.6 Lesions
Standard Deviation 13.07
|
|
Absolute Change in the Non-inflammatory Lesion Counts on the Face
Week 12
|
20.3 Lesions
Standard Deviation 13.88
|
22.1 Lesions
Standard Deviation 18.26
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: ITT Population
IGA success at Week 12 (an IGA score of 0 (Clear) or 1 (almost clear) with at least a 2-grade reduction from baseline) - will be analyzed using the Cochran-Mantel-Haenszel (CMH) test for general association
Outcome measures
| Measure |
Active
n=277 Participants
DFD-03 (0.1% tazarotene) Lotion
DFD-03: DFD-03 Lotion
|
Vehicle
n=273 Participants
Vehicle (0% tazarotene) Lotion
Placebo Comparator: Vehicle (tazarotene 0%) Lotion
|
|---|---|---|
|
Proportion of Subjects With Treatment Success Based on IGA Score
|
51 Participants
|
34 Participants
|
Adverse Events
Active
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Vehicle
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active
n=277 participants at risk
DFD-03 (0.1% tazarotene) Lotion
DFD-03: DFD-03 Lotion
|
Vehicle
n=273 participants at risk
Vehicle (0% tazarotene) Lotion
Placebo Comparator: Vehicle (tazarotene 0%) Lotion
|
|---|---|---|
|
Psychiatric disorders
Anxiety
|
0.36%
1/277 • Number of events 1 • Adverse event data were collected from the time treatment was initiated until study product treatment was discontinued, except for spontaneously reported SAEs, which were to be reported up to 30 days after discontinuing study product use.
|
0.00%
0/273 • Adverse event data were collected from the time treatment was initiated until study product treatment was discontinued, except for spontaneously reported SAEs, which were to be reported up to 30 days after discontinuing study product use.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polyps/Epithelioid
|
0.36%
1/277 • Number of events 1 • Adverse event data were collected from the time treatment was initiated until study product treatment was discontinued, except for spontaneously reported SAEs, which were to be reported up to 30 days after discontinuing study product use.
|
0.00%
0/273 • Adverse event data were collected from the time treatment was initiated until study product treatment was discontinued, except for spontaneously reported SAEs, which were to be reported up to 30 days after discontinuing study product use.
|
|
Reproductive system and breast disorders
Overian cyst ruptured
|
0.00%
0/277 • Adverse event data were collected from the time treatment was initiated until study product treatment was discontinued, except for spontaneously reported SAEs, which were to be reported up to 30 days after discontinuing study product use.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected from the time treatment was initiated until study product treatment was discontinued, 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place