Trial Outcomes & Findings for A Study Comparing Tazarotene Cream 0.05% to TAZORAC® (Tazarotene) Cream 0.05% and Both to a Placebo Control in the Treatment of Plaque Psoriasis (NCT NCT02886702)
NCT ID: NCT02886702
Last Updated: 2018-08-29
Results Overview
Proportion of subjects with treatment success (defined as none, minimal or mild disease, a score of 0, 1 or 2 within the treatment area) on the "Investigator's Global Assessment of Disease Severity" (IGA) at the Week 12 visit (Day 85 ± 4 days, End of Study).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
855 participants
Primary outcome timeframe
Week 12
Results posted on
2018-08-29
Participant Flow
At Visit 1, eligible subjects were randomized to the Test, Reference or Placebo product in a 1:1:1 ratio using an interactive response technology (IRT) system.
927 subjects were screened for study participation, 855 subjects were randomized and included in the statistical analyses. 29 investigative sites (one with two locations) randomized subjects into the study.
Participant milestones
| Measure |
Test
Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)
|
Reference
TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)
|
Placebo
Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
|
|---|---|---|---|
|
Overall Study
STARTED
|
284
|
286
|
285
|
|
Overall Study
Modified Intent-to Treat (mITT)
|
263
|
266
|
275
|
|
Overall Study
Per-Protocol Population (PP)
|
208
|
209
|
201
|
|
Overall Study
COMPLETED
|
236
|
235
|
232
|
|
Overall Study
NOT COMPLETED
|
48
|
51
|
53
|
Reasons for withdrawal
| Measure |
Test
Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)
|
Reference
TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)
|
Placebo
Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
|
|---|---|---|---|
|
Overall Study
Other
|
4
|
3
|
9
|
|
Overall Study
Withdrawal by Subject
|
24
|
18
|
22
|
|
Overall Study
Significant Worsening of Condition
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
2
|
2
|
1
|
|
Overall Study
Non-Compliance With Study Drug
|
0
|
1
|
4
|
|
Overall Study
Lost to Follow-up
|
11
|
13
|
8
|
|
Overall Study
Lack of Efficacy
|
3
|
4
|
5
|
|
Overall Study
Adverse Event
|
4
|
9
|
3
|
|
Overall Study
Administrative Reasons
|
0
|
0
|
1
|
Baseline Characteristics
Started (Safety Population)
Baseline characteristics by cohort
| Measure |
Test
n=284 Participants
Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)
|
Reference
n=286 Participants
TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)
|
Placebo
n=285 Participants
Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
|
Total
n=855 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.5 Years
STANDARD_DEVIATION 14.4 • n=93 Participants • Started (Safety Population)
|
53.7 Years
STANDARD_DEVIATION 14.2 • n=4 Participants • Started (Safety Population)
|
52.7 Years
STANDARD_DEVIATION 14.2 • n=27 Participants • Started (Safety Population)
|
53.3 Years
STANDARD_DEVIATION 14.2 • n=483 Participants • Started (Safety Population)
|
|
Sex: Female, Male
Female
|
142 Participants
n=93 Participants • Started (Safety Population)
|
129 Participants
n=4 Participants • Started (Safety Population)
|
155 Participants
n=27 Participants • Started (Safety Population)
|
426 Participants
n=483 Participants • Started (Safety Population)
|
|
Sex: Female, Male
Male
|
142 Participants
n=93 Participants • Started (Safety Population)
|
157 Participants
n=4 Participants • Started (Safety Population)
|
130 Participants
n=27 Participants • Started (Safety Population)
|
429 Participants
n=483 Participants • Started (Safety Population)
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
172 Participants
n=93 Participants • Started (Safety Population)
|
168 Participants
n=4 Participants • Started (Safety Population)
|
174 Participants
n=27 Participants • Started (Safety Population)
|
514 Participants
n=483 Participants • Started (Safety Population)
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
112 Participants
n=93 Participants • Started (Safety Population)
|
118 Participants
n=4 Participants • Started (Safety Population)
|
111 Participants
n=27 Participants • Started (Safety Population)
|
341 Participants
n=483 Participants • Started (Safety Population)
|
PRIMARY outcome
Timeframe: Week 12Population: mITT for superiority versus placebo, PP for equivalence versus Reference
Proportion of subjects with treatment success (defined as none, minimal or mild disease, a score of 0, 1 or 2 within the treatment area) on the "Investigator's Global Assessment of Disease Severity" (IGA) at the Week 12 visit (Day 85 ± 4 days, End of Study).
Outcome measures
| Measure |
Test
n=263 Participants
Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)
|
Reference
n=266 Participants
TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)
|
Placebo
n=275 Participants
Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
|
|---|---|---|---|
|
Treatment Success Assessed by IGA
|
60.8 Percentage of Participants
|
63.2 Percentage of Participants
|
56.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 12Population: mITT
Proportion of subjects with none or minimal disease, a score of 0 or 1 on the IGA at the Week 12 visit (Day 85 ± 4 days, End of Study).
Outcome measures
| Measure |
Test
n=263 Participants
Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)
|
Reference
n=266 Participants
TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)
|
Placebo
n=275 Participants
Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
|
|---|---|---|---|
|
Disease Severity None or Minimal on IGA
|
17.5 Percentage of Participants
|
22.6 Percentage of Participants
|
16.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 12Population: mITT
Proportion of subjects with target site plaque elevation, scaling and erythema scores of less than or equal to 1 (Clear or Almost Clear) on the Psoriasis Area Severity Index (PASI) at the Week 12 visit (Day 85 ± 4 days, End of Study).
Outcome measures
| Measure |
Test
n=263 Participants
Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)
|
Reference
n=266 Participants
TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)
|
Placebo
n=275 Participants
Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
|
|---|---|---|---|
|
Target Site Plaque Elevation, Scaling and Erythema Scores of Less Than or Equal to 1 on the PASI
|
16.3 Percentage of Participants
|
22.2 Percentage of Participants
|
16.0 Percentage of Participants
|
Adverse Events
Test
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Reference
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Test
n=284 participants at risk
Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)
|
Reference
n=286 participants at risk
TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)
|
Placebo
n=285 participants at risk
Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/284 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
0.00%
0/286 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
0.35%
1/285 • Number of events 1 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/284 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
0.00%
0/286 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
0.35%
1/285 • Number of events 1 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/284 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
0.00%
0/286 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
0.35%
1/285 • Number of events 1 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
|
Renal and urinary disorders
Ischaemic nephropathy
|
0.00%
0/284 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
0.00%
0/286 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
0.35%
1/285 • Number of events 1 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/284 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
0.00%
0/286 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
0.35%
1/285 • Number of events 1 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/284 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
0.00%
0/286 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
0.35%
1/285 • Number of events 1 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/284 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
0.00%
0/286 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
0.35%
1/285 • Number of events 1 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
Other adverse events
| Measure |
Test
n=284 participants at risk
Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)
|
Reference
n=286 participants at risk
TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)
|
Placebo
n=285 participants at risk
Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
|
|---|---|---|---|
|
General disorders
Application site dryness
|
0.70%
2/284 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
1.4%
4/286 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
0.70%
2/285 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
|
General disorders
Application site erosion
|
1.8%
5/284 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
1.4%
4/286 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
2.1%
6/285 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
|
General disorders
Application site erythema
|
1.8%
5/284 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
1.7%
5/286 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
1.4%
4/285 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
|
General disorders
Application site pain
|
3.2%
9/284 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
3.1%
9/286 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
3.5%
10/285 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
|
General disorders
Application site pruritus
|
2.8%
8/284 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
1.4%
4/286 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
1.4%
4/285 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
|
General disorders
Application site rash
|
0.70%
2/284 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
1.7%
5/286 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
0.35%
1/285 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
|
Infections and infestations
Nasopharyngitis
|
1.8%
5/284 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
0.70%
2/286 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
1.1%
3/285 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
|
Infections and infestations
Sinusitis
|
0.00%
0/284 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
0.35%
1/286 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
1.1%
3/285 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
|
Nervous system disorders
Headache
|
2.1%
6/284 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
0.70%
2/286 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
1.1%
3/285 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.70%
2/284 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
1.0%
3/286 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
0.35%
1/285 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
|
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