Phase 3 N=2,102 Randomized Triple-blind Treatment

A Safety and Efficacy Study of Dapsone Gel in Patients With Acne Vulgaris

Acne Vulgaris

Bottom Line

View on ClinicalTrials.gov: NCT01974141 ↗

Enrolled (actual)

2,102

Serious AEs

0.4%

Results posted

Feb 2017

Primary outcome: 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 Percentage of Patients

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Dapsone Gel (Drug); Dapsone Gel Vehicle (Drug)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: Almirall, S.A.
Primary completion: Oct 2014

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	—

Summary

This study will assess the safety and efficacy of dapsone gel versus vehicle control in patients with acne vulgaris.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01974141). 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.