Acne Vulgaris
Conditions
Brief summary
Comparison of the safety and efficacy of Tazarotene Cream 0.1% compared with Adapalene Gel 0.3% in treating moderate to severe facial acne vulgaris
Interventions
1 pea-size amount, QD x 16 weeks
DRUGAdapalene
1 pea-size amount, QD x 16 weeks
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Facial acne vulgaris characterized by the following: 25-100 facial inflammatory lesions (papules plus pustules); and 40 or more non-inflammatory lesions (open/closed comedones)); stable disease, non-rapidly regressing facial acne vulgaris; and, 3 or less facial nodules and/or cysts (diameter of 1cm or greater). * Female subjects of childbearing potential must have a negative urine pregnancy test at baseline and practice reliable method of contraception throughout the study.
Exclusion criteria
* Non-compliance with washout period * Skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris * Allergy or sensitivity to any component of the test medications * Cosmetic or surgical procedure complementary to the treatment of facial acne within 14 days of the baseline visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Percent Change From Baseline in the Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12 | Baseline, Week 12 | Median percent change from baseline in the non-inflammatory lesion counts (open and closed comedones) at Week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts(improvement). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With >= 1 Grade Improvement in the Investigator Global Assessment at Week 16 | Week 16 | Percentage of patients with \>= 1 grade improvement (decrease in score) in the Investigator Global Assessment (IGA) at Week 16. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne. |
| Percentage of Patients With >= 2 Grade Improvement in the Overall Disease Severity Score at Week 12 | Week 12 | Percentage of patients with \>= 2 grade improvement (decrease in score) in the overall disease severity score at Week 12. The overall disease severity score was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness, and skin condition), where 0=no acne lesions and 6=most severe acne. |
| Median Percent Change From Baseline in Inflammatory Lesion Counts (Papules/Pustules, Nodules) at Week 16 | Baseline, Week 16 | Median percent change from baseline in inflammatory lesion counts (papules/pustules, nodules) at Week 16. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 to 10 millimeters in width and depth) and nodules are larger (greater than 5 to 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tazarotene Cream 0.1% 1 pea-size amount, QD x 16 weeks | 77 |
| Adapalene Gel 0.3% 1 pea-size amount, QD x 16 weeks | 88 |
| Total | 165 |
Baseline characteristics
| Characteristic | Tazarotene Cream 0.1% | Adapalene Gel 0.3% | Total |
|---|---|---|---|
| Age Continuous | 20.9 years FULL_RANGE 7.7 | 20.8 years FULL_RANGE 7.6 | 20.9 years FULL_RANGE 7.6 |
| Sex: Female, Male Female | 48 Participants | 56 Participants | 104 Participants |
| Sex: Female, Male Male | 29 Participants | 32 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 72 | 9 / 85 |
| serious Total, serious adverse events | 0 / 72 | 0 / 85 |
Outcome results
Primary
Median Percent Change From Baseline in the Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12
Median percent change from baseline in the non-inflammatory lesion counts (open and closed comedones) at Week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts(improvement).
Time frame: Baseline, Week 12
Population: Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tazarotene Cream 0.1% | Median Percent Change From Baseline in the Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12 | -68.14 Percent Change |
| Adapalene Gel 0.3% | Median Percent Change From Baseline in the Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12 | -60.00 Percent Change |
Secondary
Median Percent Change From Baseline in Inflammatory Lesion Counts (Papules/Pustules, Nodules) at Week 16
Median percent change from baseline in inflammatory lesion counts (papules/pustules, nodules) at Week 16. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 to 10 millimeters in width and depth) and nodules are larger (greater than 5 to 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).
Time frame: Baseline, Week 16
Population: Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tazarotene Cream 0.1% | Median Percent Change From Baseline in Inflammatory Lesion Counts (Papules/Pustules, Nodules) at Week 16 | -67.86 Percent Change |
| Adapalene Gel 0.3% | Median Percent Change From Baseline in Inflammatory Lesion Counts (Papules/Pustules, Nodules) at Week 16 | -55.56 Percent Change |
Secondary
Percentage of Patients With >= 1 Grade Improvement in the Investigator Global Assessment at Week 16
Percentage of patients with \>= 1 grade improvement (decrease in score) in the Investigator Global Assessment (IGA) at Week 16. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne.
Time frame: Week 16
Population: Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tazarotene Cream 0.1% | Percentage of Patients With >= 1 Grade Improvement in the Investigator Global Assessment at Week 16 | 77.0 Percentage of patients |
| Adapalene Gel 0.3% | Percentage of Patients With >= 1 Grade Improvement in the Investigator Global Assessment at Week 16 | 66.7 Percentage of patients |
Secondary
Percentage of Patients With >= 2 Grade Improvement in the Overall Disease Severity Score at Week 12
Percentage of patients with \>= 2 grade improvement (decrease in score) in the overall disease severity score at Week 12. The overall disease severity score was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness, and skin condition), where 0=no acne lesions and 6=most severe acne.
Time frame: Week 12
Population: Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tazarotene Cream 0.1% | Percentage of Patients With >= 2 Grade Improvement in the Overall Disease Severity Score at Week 12 | 50.8 Percentage of patients |
| Adapalene Gel 0.3% | Percentage of Patients With >= 2 Grade Improvement in the Overall Disease Severity Score at Week 12 | 32.9 Percentage of patients |