Phase 3
Completed N=2,102
A Safety and Efficacy Study of Dapsone Gel in Patients With Acne Vulgaris
Source: ClinicalTrials.gov NCT01974141 ↗Enrolled (actual)
2,102
Serious AEs
0.4%
Results posted
Feb 2017
Primary outcomePrimary: Percentage of Patients With a Score of 0 (None) or 1 (Minimal) on the 5-point Global Acne Assessment Score (GAAS) — 29.9; 21.2 Percentage of Patients
◆ Published Evidence
Emerging
17citations · ~2 / year
Efficacy, Safety, and Dermal Tolerability of Dapsone Gel, 7.5% in Patients with Moderate Acne Vulgaris: A Pooled Analysis of Two Phase 3 Trials.
Summary
This study will assess the safety and efficacy of dapsone gel versus vehicle control in patients with acne vulgaris.
Linked Publications (4)
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Efficacy, Safety, and Dermal Tolerability of Dapsone Gel, 7.5% in Patients with Moderate Acne Vulgaris: A Pooled Analysis of Two Phase 3 Trials.
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Once-Daily Topical Dapsone Gel, 7.5%: Effective for Acne Vulgaris Regardless of Baseline Lesion Count, With Superior Efficacy in Females
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Once-Daily Topical Dapsone Gel, 7.5%: Effective for Acne Vulgaris Regardless of Baseline Lesion Count, With Superior Efficacy in Females
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Once-Daily Topical Dapsone Gel, 7.5%: Effective for Acne Vulgaris Regardless of Baseline Lesion Count, With Superior Efficacy in Females
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With a Score of 0 (None) or 1 (Minimal) on the 5-point Global Acne Assessment Score (GAAS) |
29.9; 21.2 | — |
| PRIMARY Change From Baseline in Inflammatory Facial Lesion Counts |
29.0; 29.4; -16.1; -14.1 | — |
| PRIMARY Change From Baseline in Noninflammatory Facial Lesion Counts |
47.0; 48.7; -20.8; -17.6 | — |
| SECONDARY Change From Baseline in Total Lesion Counts |
75.9; 78.1; -36.9; -31.7 | — |
| SECONDARY Percentage Change From Baseline in Total Lesion Counts |
-48.7; -42.4 | — |
| SECONDARY Percentage of Patients Reporting "Very Good" or "Excellent" on Item 10 of the 5-Point Acne Symptom Impact Scale (ASIS) |
23.8; 19.2 | — |
| SECONDARY Change From Baseline in the 9-Item ASIS Sign Domain Score |
4.2; 4.2; -0.73; -0.69 | — |
| SECONDARY Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Oiliness on a the 5-Point ASIS Scale |
45.7; 51.8 | — |
| SECONDARY Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Redness on a the 5-Point ASIS Scale |
55.6; 53.0 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of acne vulgaris
- Willing to avoid excessive or prolonged exposure to ultraviolet light (eg, sunlight, tanning beds) throughout the study
Exclusion Criteria
- Severe cystic acne, acne conglobata, acne fulminans, or secondary acne
- Use of phototherapy devices (eg, ClearLight™), energy-based devices, adhesive cleansing strips (eg, Pond's®, Biore®), or cosmetic procedures (eg, facials, peeling, comedo extraction) in the past week
- Use of anti-inflammatory medications, salicylic acid; corticosteroids, antibiotics, antibacterials (including benzoyl peroxide-containing products [eg, benzamycin]), retinoids; other topical acne treatments (eg, photodynamic therapy, medicated soaps such as those containing benzoyl peroxide, salicylic acid, sulfur, or sodium sulfacetamide) in the past 2 weeks
- Use of birth control pills strictly for acne control
Data sourced from ClinicalTrials.gov (NCT01974141) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.