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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Dapsone gel 5% and Tretinoin gel 0.025% |
|
| 2 | Active Comparator | Tretinoin gel 0.025% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapsone; Tretinoin | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, Week 12 |
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Inclusion Criteria:
Facial acne vulgaris characterized by the following:
Female subjects of childbearing potential must have a negative pregnancy test at baseline and practice reliable method of contraception throughout the study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Strongsville | Ohio | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tretinoin Gel 0.025% | Tretinoin gel 0.025% |
| FG001 | Dapsone Gel 5% and Tretinoin Gel 0.025% | Dapsone gel 5% and Tretinoin gel 0.025% |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tretinoin Gel 0.025% | Tretinoin gel 0.025% |
| BG001 | Dapsone Gel 5% and Tretinoin Gel 0.025% | Dapsone gel 5% and Tretinoin gel 0.025% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Intent-to-treat (ITT), which included all patients who started the study (randomized). | Posted | Mean | Standard Deviation | Number of Lesions | Baseline, Week 12 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tretinoin Gel 0.025% | Tretinoin gel 0.025% |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs | Allergan, Inc. | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D003622 | Dapsone |
| D014212 | Tretinoin |
| ID | Term |
|---|---|
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D014801 | Vitamin A |
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| Tretinoin | Drug | Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks |
|
|
| 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). | Baseline, Week 12 |
| 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). | Baseline, Week 12 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Dapsone Gel 5% and Tretinoin Gel 0.025% |
Dapsone gel 5% and Tretinoin gel 0.025% |
|
|
| 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). | Intent-to-treat (ITT), which included all patients who started the study (randomized). | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 12 |
|
|
|
| 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). | Intent-to-treat (ITT), which included all patients who started the study (randomized). | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 12 |
|
|
|
| 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). | Intent-to-treat (ITT), which included all patients who started the study (randomized). | Posted | Mean | Standard Deviation | Number of lesions | Baseline, Week 12 |
|
|
|
| 0 |
| 82 |
| 12 |
| 82 |
| EG001 | Dapsone Gel 5% and Tretinoin Gel 0.025% | Dapsone gel 5% and Tretinoin gel 0.025% | 0 | 81 | 10 | 81 |
| Headache | Nervous system disorders | Non-systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
| D012176 |
| Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |