Trial Outcomes & Findings for A Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both to a Placebo Control in the Treatment of Acne Vulgaris (NCT NCT02886715)
NCT ID: NCT02886715
Last Updated: 2018-08-17
Results Overview
Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1110 participants
Primary outcome timeframe
Week 12
Results posted on
2018-08-17
Participant Flow
At Baseline Visit eligible subjects were randomized to the Test, Reference or Placebo product in a 2:2:1 ratio using an interactive response technology (IRT) system
1154 subjects were screened for study participation, 1110 subjects were randomized and included in the statistical analyses. 25 investigative sites randomized subjects into the study.
Participant milestones
| Measure |
Test
Tazarotene Cream 0.1% (Fougera Pharmaceuticals Inc.)
|
Reference
TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.)
|
Placebo
Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
|
|---|---|---|---|
|
Overall Study
STARTED
|
442
|
445
|
223
|
|
Overall Study
Modified ITT (mITT)
|
421
|
418
|
217
|
|
Overall Study
Per Protocol (PP) Population
|
346
|
351
|
176
|
|
Overall Study
COMPLETED
|
378
|
390
|
203
|
|
Overall Study
NOT COMPLETED
|
64
|
55
|
20
|
Reasons for withdrawal
| Measure |
Test
Tazarotene Cream 0.1% (Fougera Pharmaceuticals Inc.)
|
Reference
TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.)
|
Placebo
Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
|
|---|---|---|---|
|
Overall Study
Non-Compliance With Study Drug
|
0
|
2
|
0
|
|
Overall Study
Adverse Event
|
4
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
29
|
26
|
10
|
|
Overall Study
Pregnancy
|
1
|
1
|
1
|
|
Overall Study
Protocol Violation
|
3
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
20
|
18
|
5
|
|
Overall Study
missing
|
7
|
2
|
2
|
Baseline Characteristics
Started (Safety Population)
Baseline characteristics by cohort
| Measure |
Test
n=442 Participants
Tazarotene Cream 0.1% (Fougera Pharmaceuticals Inc.)
|
Reference
n=445 Participants
TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.)
|
Placebo
n=223 Participants
Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
|
Total
n=1110 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
22.5 Years
STANDARD_DEVIATION 7.0 • n=93 Participants • Started (Safety Population)
|
22.7 Years
STANDARD_DEVIATION 7.0 • n=4 Participants • Started (Safety Population)
|
22.5 Years
STANDARD_DEVIATION 7.0 • n=27 Participants • Started (Safety Population)
|
22.6 Years
STANDARD_DEVIATION 7.0 • n=483 Participants • Started (Safety Population)
|
|
Sex: Female, Male
Female
|
236 Participants
n=93 Participants • Started (Safety Population)
|
215 Participants
n=4 Participants • Started (Safety Population)
|
96 Participants
n=27 Participants • Started (Safety Population)
|
547 Participants
n=483 Participants • Started (Safety Population)
|
|
Sex: Female, Male
Male
|
206 Participants
n=93 Participants • Started (Safety Population)
|
230 Participants
n=4 Participants • Started (Safety Population)
|
127 Participants
n=27 Participants • Started (Safety Population)
|
563 Participants
n=483 Participants • Started (Safety Population)
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
265 Participants
n=93 Participants • Started (Safety Population)
|
252 Participants
n=4 Participants • Started (Safety Population)
|
130 Participants
n=27 Participants • Started (Safety Population)
|
647 Participants
n=483 Participants • Started (Safety Population)
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
177 Participants
n=93 Participants • Started (Safety Population)
|
193 Participants
n=4 Participants • Started (Safety Population)
|
93 Participants
n=27 Participants • Started (Safety Population)
|
463 Participants
n=483 Participants • Started (Safety Population)
|
PRIMARY outcome
Timeframe: Week 12Population: mITT for superiority versus placebo, PP for equivalence versus Reference
Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts
Outcome measures
| Measure |
Test
n=421 Participants
Tazarotene Cream 0.1% (Fougera Pharmaceuticals Inc.)
|
Reference
n=418 Participants
TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.)
|
Placebo
n=217 Participants
Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
|
|---|---|---|---|
|
Change in Inflammatory Lesion Counts
|
-58.44 percent change
Standard Error 1.33
|
-60.07 percent change
Standard Error 1.32
|
-53.28 percent change
Standard Error 1.81
|
PRIMARY outcome
Timeframe: Week 12Population: mITT for superiority versus placebo, PP for equivalence versus Reference
Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts
Outcome measures
| Measure |
Test
n=421 Participants
Tazarotene Cream 0.1% (Fougera Pharmaceuticals Inc.)
|
Reference
n=418 Participants
TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.)
|
Placebo
n=217 Participants
Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
|
|---|---|---|---|
|
Change in Non-inflammatory Lesion Counts
|
-50.11 percent change
Standard Error 1.27
|
-51.99 percent change
Standard Error 1.26
|
-45.72 percent change
Standard Error 1.73
|
SECONDARY outcome
Timeframe: Week 12Population: mITT
The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment
Outcome measures
| Measure |
Test
n=421 Participants
Tazarotene Cream 0.1% (Fougera Pharmaceuticals Inc.)
|
Reference
n=418 Participants
TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.)
|
Placebo
n=217 Participants
Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
|
|---|---|---|---|
|
Clinical Response of Success
|
20.0 percentage of participants
|
23.7 percentage of participants
|
15.2 percentage of participants
|
Adverse Events
Test
Serious events: 1 serious events
Other events: 45 other events
Deaths: 0 deaths
Reference
Serious events: 0 serious events
Other events: 57 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Test
n=442 participants at risk
Tazarotene Cream 0.1% (Fougera Pharmaceuticals Inc.)
|
Reference
n=445 participants at risk
TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.)
|
Placebo
n=223 participants at risk
Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
|
|---|---|---|---|
|
Psychiatric disorders
Suicide attempt
|
0.23%
1/442 • Number of events 1 • From baseline to week 12 (end of study)
|
0.00%
0/445 • From baseline to week 12 (end of study)
|
0.00%
0/223 • From baseline to week 12 (end of study)
|
Other adverse events
| Measure |
Test
n=442 participants at risk
Tazarotene Cream 0.1% (Fougera Pharmaceuticals Inc.)
|
Reference
n=445 participants at risk
TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.)
|
Placebo
n=223 participants at risk
Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
|
|---|---|---|---|
|
General disorders
Application site dryness
|
2.5%
11/442 • From baseline to week 12 (end of study)
|
3.4%
15/445 • From baseline to week 12 (end of study)
|
0.90%
2/223 • From baseline to week 12 (end of study)
|
|
General disorders
Application site exfoliation
|
1.6%
7/442 • From baseline to week 12 (end of study)
|
1.8%
8/445 • From baseline to week 12 (end of study)
|
0.45%
1/223 • From baseline to week 12 (end of study)
|
|
General disorders
Application site pain
|
3.6%
16/442 • From baseline to week 12 (end of study)
|
2.0%
9/445 • From baseline to week 12 (end of study)
|
0.45%
1/223 • From baseline to week 12 (end of study)
|
|
General disorders
Application site pruritus
|
1.1%
5/442 • From baseline to week 12 (end of study)
|
2.2%
10/445 • From baseline to week 12 (end of study)
|
1.8%
4/223 • From baseline to week 12 (end of study)
|
|
Infections and infestations
Nasopharyngitis
|
1.1%
5/442 • From baseline to week 12 (end of study)
|
2.2%
10/445 • From baseline to week 12 (end of study)
|
0.90%
2/223 • From baseline to week 12 (end of study)
|
|
Nervous system disorders
Headache
|
1.6%
7/442 • From baseline to week 12 (end of study)
|
1.3%
6/445 • From baseline to week 12 (end of study)
|
1.3%
3/223 • From baseline to week 12 (end of study)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.23%
1/442 • From baseline to week 12 (end of study)
|
2.0%
9/445 • From baseline to week 12 (end of study)
|
0.90%
2/223 • From baseline to week 12 (end of study)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.68%
3/442 • From baseline to week 12 (end of study)
|
1.6%
7/445 • From baseline to week 12 (end of study)
|
0.00%
0/223 • From baseline to week 12 (end of study)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Fougera' agreements with its investigators may vary. However, Fougera does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER