Plaque Psoriasis
Conditions
Brief summary
A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.05% to TAZORAC® (tazarotene) Cream 0.05% and Both Active Treatments to a Vehicle Control in the Treatment of Stable Plaque Psoriasis
Interventions
DRUGTazarotene Cream 0.05%
Tazarotene Cream 0.05% to cover only the lesions with a thin film.
DRUGTAZORAC® (tazarotene) Cream 0.05%
TAZORAC® (tazarotene) Cream 0.05% to cover only the lesions with a thin film.
DRUGPlacebo
Placebo (vehicle of the test product) to cover only the lesions with a thin film.
Sponsors
Fougera Pharmaceuticals Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a definite clinical diagnosis of stable (at least 6 months) plaque psoriasis, involving at least 2% and no more than 20% of the body surface area (BSA) (not including the scalp and intertriginous areas) * Have a minimum plaque elevation at the target lesion site of at least moderate severity (grade ≥ 3 on the Psoriasis Area Severity Index \[PASI\]). The most severe lesion at baseline should be identified as the target lesion * Have an Investigator's Global Assessment (IGA) of disease severity of at least moderate (score ≥ 3) as an overall assessment of all lesions to be treated.
Exclusion criteria
* A female subject who is pregnant, nursing, planning a pregnancy, or does not agree to use an acceptable form of birth control within the study participation period * Have a current diagnosis of unstable forms of psoriasis in the treatment area, including pustular, guttate, exfoliative or erythrodermic psoriasis * Have a history of psoriasis unresponsive to topical treatments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Success Assessed by IGA | Week 12 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Severity None or Minimal on IGA | Week 12 | 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). |
| Target Site Plaque Elevation, Scaling and Erythema Scores of Less Than or Equal to 1 on the PASI | Week 12 | 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). |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Test Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.) | 284 |
| Reference TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.) | 286 |
| Placebo Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.) | 285 |
| Total | 855 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administrative Reasons | 0 | 0 | 1 |
| Overall Study | Adverse Event | 4 | 9 | 3 |
| Overall Study | Lack of Efficacy | 3 | 4 | 5 |
| Overall Study | Lost to Follow-up | 11 | 13 | 8 |
| Overall Study | Non-Compliance With Study Drug | 0 | 1 | 4 |
| Overall Study | Other | 4 | 3 | 9 |
| Overall Study | Protocol Violation | 2 | 2 | 1 |
| Overall Study | Significant Worsening of Condition | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 24 | 18 | 22 |
Baseline characteristics
| Characteristic | Test | Reference | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 53.5 Years STANDARD_DEVIATION 14.4 | 53.7 Years STANDARD_DEVIATION 14.2 | 52.7 Years STANDARD_DEVIATION 14.2 | 53.3 Years STANDARD_DEVIATION 14.2 |
| Race/Ethnicity, Customized Hispanic or Latino | 172 Participants | 168 Participants | 174 Participants | 514 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 112 Participants | 118 Participants | 111 Participants | 341 Participants |
| Sex: Female, Male Female | 142 Participants | 129 Participants | 155 Participants | 426 Participants |
| Sex: Female, Male Male | 142 Participants | 157 Participants | 130 Participants | 429 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 284 | 0 / 286 | 0 / 285 |
| other Total, other adverse events | 31 / 284 | 24 / 286 | 21 / 285 |
| serious Total, serious adverse events | 0 / 284 | 0 / 286 | 3 / 285 |
Outcome results
Primary
Treatment Success Assessed by IGA
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).
Time frame: Week 12
Population: mITT for superiority versus placebo, PP for equivalence versus Reference
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test | Treatment Success Assessed by IGA | 60.8 Percentage of Participants |
| Reference | Treatment Success Assessed by IGA | 63.2 Percentage of Participants |
| Placebo | Treatment Success Assessed by IGA | 56.0 Percentage of Participants |
90% CI: [-12.6, 3.6]Yates' corrected confidence interval
p-value: 0.352Cochran-Mantel-Haenszel
Secondary
Disease Severity None or Minimal on IGA
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).
Time frame: Week 12
Population: mITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test | Disease Severity None or Minimal on IGA | 17.5 Percentage of Participants |
| Reference | Disease Severity None or Minimal on IGA | 22.6 Percentage of Participants |
| Placebo | Disease Severity None or Minimal on IGA | 16.4 Percentage of Participants |
p-value: 0.8105Cochran-Mantel-Haenszel
p-value: 0.0613Cochran-Mantel-Haenszel
Secondary
Target Site Plaque Elevation, Scaling and Erythema Scores of Less Than or Equal to 1 on the PASI
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).
Time frame: Week 12
Population: mITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test | Target Site Plaque Elevation, Scaling and Erythema Scores of Less Than or Equal to 1 on the PASI | 16.3 Percentage of Participants |
| Reference | Target Site Plaque Elevation, Scaling and Erythema Scores of Less Than or Equal to 1 on the PASI | 22.2 Percentage of Participants |
| Placebo | Target Site Plaque Elevation, Scaling and Erythema Scores of Less Than or Equal to 1 on the PASI | 16.0 Percentage of Participants |
p-value: 1Cochran-Mantel-Haenszel
p-value: 0.0712Cochran-Mantel-Haenszel