Acne Vulgaris
Conditions
Brief summary
A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tretinoin gel 0.025% compared with tretinoin gel 0.025% monotherapy in treating moderate to severe facial acne vulgaris
Interventions
DRUGDapsone; Tretinoin
Dapsone topical gel 5%, 1 pea-size amount BID x 12 weeks and Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks
DRUGTretinoin
Tretinoin gel 0.025%, 1 pea-size amount QD x 12 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: * 30-100 facial inflammatory lesions; and, 25-100 facial non-inflammatory lesions; * Stable disease, non-rapidly regressing facial acne vulgaris; and, less than or equal to 3 nodules and/or cysts (diameter greater than or equal to 1cm) * Female subjects of childbearing potential must have a negative pregnancy test at baseline and practice reliable method of contraception throughout the study
Exclusion criteria
* Non-compliance with washout period; * History of clinically significant anemia or hemolysis; * Skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris; * Allergy or sensitivity to any component of the test medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12 | Baseline, Week 12 | Change from baseline in inflammatory lesion counts (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Investigator Global Assessment at Week 12 | Baseline, Week 12 | Change from baseline in the Investigator Global Assessment (IGA) at week 12. 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. A negative number change from baseline indicates a reduction in acne severity (improvement). |
| Change From Baseline in Overall Disease Severity at Week 12 | Baseline, Week 12 | Change from baseline in overall disease severity at week 12. The overall disease severity 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. A negative number change from baseline indicates a reduction in overall acne disease severity (improvement). |
| Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12 | Baseline, Week 12 | Change from baseline in non-inflammatory lesion counts (open/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 a 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tretinoin Gel 0.025% Tretinoin gel 0.025% | 82 |
| Dapsone Gel 5% and Tretinoin Gel 0.025% Dapsone gel 5% and Tretinoin gel 0.025% | 81 |
| Total | 163 |
Baseline characteristics
| Characteristic | Tretinoin Gel 0.025% | Dapsone Gel 5% and Tretinoin Gel 0.025% | Total |
|---|---|---|---|
| Age Continuous | 20.2 years | 19.7 years | 20.0 years |
| Sex: Female, Male Female | 44 Participants | 38 Participants | 82 Participants |
| Sex: Female, Male Male | 38 Participants | 43 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 82 | 10 / 81 |
| serious Total, serious adverse events | 0 / 82 | 0 / 81 |
Outcome results
Primary
Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12
Change from baseline in inflammatory lesion counts (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 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 12
Population: Intent-to-treat (ITT), which included all patients who started the study (randomized).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tretinoin Gel 0.025% | Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12 | Baseline | 38.96 Number of Lesions | Standard Deviation 6.3 |
| Tretinoin Gel 0.025% | Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12 | Week 12 | -24.05 Number of Lesions | Standard Deviation 13.02 |
| Dapsone Gel 5% and Tretinoin Gel 0.025% | Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12 | Baseline | 40.06 Number of Lesions | Standard Deviation 9.4 |
| Dapsone Gel 5% and Tretinoin Gel 0.025% | Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12 | Week 12 | -25.82 Number of Lesions | Standard Deviation 12.36 |
Secondary
Change From Baseline in Investigator Global Assessment at Week 12
Change from baseline in the Investigator Global Assessment (IGA) at week 12. 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. A negative number change from baseline indicates a reduction in acne severity (improvement).
Time frame: Baseline, Week 12
Population: Intent-to-treat (ITT), which included all patients who started the study (randomized).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tretinoin Gel 0.025% | Change From Baseline in Investigator Global Assessment at Week 12 | Baseline | 3.02 Scores on a scale | Standard Deviation 0.47 |
| Tretinoin Gel 0.025% | Change From Baseline in Investigator Global Assessment at Week 12 | Week 12 | -1.07 Scores on a scale | Standard Deviation 0.85 |
| Dapsone Gel 5% and Tretinoin Gel 0.025% | Change From Baseline in Investigator Global Assessment at Week 12 | Baseline | 2.99 Scores on a scale | Standard Deviation 0.43 |
| Dapsone Gel 5% and Tretinoin Gel 0.025% | Change From Baseline in Investigator Global Assessment at Week 12 | Week 12 | -1.08 Scores on a scale | Standard Deviation 0.89 |
Secondary
Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12
Change from baseline in non-inflammatory lesion counts (open/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 a 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 (ITT), which included all patients who started the study (randomized).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tretinoin Gel 0.025% | Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12 | Baseline | 40.94 Number of lesions | Standard Deviation 11.13 |
| Tretinoin Gel 0.025% | Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12 | Week 12 | -19.91 Number of lesions | Standard Deviation 13.2 |
| Dapsone Gel 5% and Tretinoin Gel 0.025% | Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12 | Baseline | 40.69 Number of lesions | Standard Deviation 10.17 |
| Dapsone Gel 5% and Tretinoin Gel 0.025% | Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12 | Week 12 | -15.81 Number of lesions | Standard Deviation 21.3 |
Secondary
Change From Baseline in Overall Disease Severity at Week 12
Change from baseline in overall disease severity at week 12. The overall disease severity 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. A negative number change from baseline indicates a reduction in overall acne disease severity (improvement).
Time frame: Baseline, Week 12
Population: Intent-to-treat (ITT), which included all patients who started the study (randomized).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tretinoin Gel 0.025% | Change From Baseline in Overall Disease Severity at Week 12 | Baseline | 4.14 Scores on a scale | Standard Deviation 0.72 |
| Tretinoin Gel 0.025% | Change From Baseline in Overall Disease Severity at Week 12 | Week 12 | -1.79 Scores on a scale | Standard Deviation 1.21 |
| Dapsone Gel 5% and Tretinoin Gel 0.025% | Change From Baseline in Overall Disease Severity at Week 12 | Baseline | 4.05 Scores on a scale | Standard Deviation 0.77 |
| Dapsone Gel 5% and Tretinoin Gel 0.025% | Change From Baseline in Overall Disease Severity at Week 12 | Week 12 | -1.76 Scores on a scale | Standard Deviation 1.29 |