Acne Vulgaris
Conditions
Brief summary
A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris
Interventions
Tazarotene Cream 0.1% applied to cover the affected areas of the face once daily for 84 +/- 4 days.
DRUGTazorac®
Tazorac® applied to cover the affected areas of the face once daily for 84 +/- 4 days.
DRUGPlacebo
Placebo (vehicle of the test product) applied to cover the affected areas of the face once daily for 84 +/- 4 days.
Sponsors
Fougera Pharmaceuticals Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris. * Must have a minimum of ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and ≤ 2 nodulocystic lesions at baseline on the face. * Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment.
Exclusion criteria
* Female subjects who are pregnant, nursing or planning to become pregnant during study participation. * Have a history of hypersensitivity or allergy to tazarotene, retinoids and/or any of the study medication ingredients. * Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Inflammatory Lesion Counts | Week 12 | Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts |
| Change in Non-inflammatory Lesion Counts | Week 12 | Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response of Success | Week 12 | 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 |
Countries
United States
Participant flow
Recruitment details
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
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Test Tazarotene Cream 0.1% (Fougera Pharmaceuticals Inc.) | 442 |
| Reference TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.) | 445 |
| Placebo Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.) | 223 |
| Total | 1,110 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 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 | missing | 7 | 2 | 2 |
| Overall Study | Non-Compliance With Study Drug | 0 | 2 | 0 |
| Overall Study | Pregnancy | 1 | 1 | 1 |
| Overall Study | Protocol Violation | 3 | 2 | 1 |
| Overall Study | Withdrawal by Subject | 20 | 18 | 5 |
Baseline characteristics
| Characteristic | Test | Reference | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 22.5 Years STANDARD_DEVIATION 7 | 22.7 Years STANDARD_DEVIATION 7 | 22.5 Years STANDARD_DEVIATION 7 | 22.6 Years STANDARD_DEVIATION 7 |
| Race/Ethnicity, Customized Hispanic or Latino | 265 Participants | 252 Participants | 130 Participants | 647 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 177 Participants | 193 Participants | 93 Participants | 463 Participants |
| Sex: Female, Male Female | 236 Participants | 215 Participants | 96 Participants | 547 Participants |
| Sex: Female, Male Male | 206 Participants | 230 Participants | 127 Participants | 563 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 442 | 0 / 445 | 0 / 223 |
| other Total, other adverse events | 45 / 442 | 57 / 445 | 12 / 223 |
| serious Total, serious adverse events | 1 / 442 | 0 / 445 | 0 / 223 |
Outcome results
Primary
Change in Inflammatory Lesion Counts
Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts
Time frame: Week 12
Population: mITT for superiority versus placebo, PP for equivalence versus Reference
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Test | Change in Inflammatory Lesion Counts | -58.44 percent change | Standard Error 1.33 |
| Reference | Change in Inflammatory Lesion Counts | -60.07 percent change | Standard Error 1.32 |
| Placebo | Change in Inflammatory Lesion Counts | -53.28 percent change | Standard Error 1.81 |
90% CI: [94.39, 103.31]ANOVA
p-value: 0.018595% CI: [-9.46, -0.87]ANOVA
Primary
Change in Non-inflammatory Lesion Counts
Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts
Time frame: Week 12
Population: mITT for superiority versus placebo, PP for equivalence versus Reference
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Test | Change in Non-inflammatory Lesion Counts | -50.11 percent change | Standard Error 1.27 |
| Reference | Change in Non-inflammatory Lesion Counts | -51.99 percent change | Standard Error 1.26 |
| Placebo | Change in Non-inflammatory Lesion Counts | -45.72 percent change | Standard Error 1.73 |
90% CI: [93.42, 103.61]ANOVA
p-value: 0.035495% CI: [-8.48, -0.3]ANOVA
Secondary
Clinical Response of Success
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
Time frame: Week 12
Population: mITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test | Clinical Response of Success | 20.0 percentage of participants |
| Reference | Clinical Response of Success | 23.7 percentage of participants |
| Placebo | Clinical Response of Success | 15.2 percentage of participants |