Phase 4 N=171 Randomized Single-blind Treatment

Dapsone Gel 5% and Tazarotene Cream 0.1% Versus Tazarotene Cream 0.1% Monotherapy for Facial Acne Vulgaris

Acne Vulgaris

Bottom Line

View on ClinicalTrials.gov: NCT00834210 ↗

Enrolled (actual)

171

Serious AEs

0.0%

Results posted

Oct 2011

Primary outcome: Primary: Change From Baseline in Inflammatory Lesion Counts (Papules,Pustules, and Nodules) at Week 12 — 38.94; 40.78; -25.77; -24.82 Number of Lesions

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Dapsone (Drug); Tazarotene (Drug)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: Allergan
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Inflammatory Lesion Counts (Papules,Pustules, and Nodules) at Week 12	38.94; 40.78; -25.77; -24.82	—
SECONDARY Change From Baseline in Investigator Global Assessment at Week 12	2.93; 3.04; -1.07; -0.96	—
SECONDARY Change From Baseline in Overall Disease Severity at Week 12	4.03; 4.08; -1.93; -1.63	—
SECONDARY Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12	46.42; 46.48; -26.73; -21.74	—

Summary

A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tazarotene cream 0.1% compared with tazarotene cream 0.1% monotherapy in treating moderate to severe facial acne vulgaris

Eligibility Criteria

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, 3 or more nodules and/or cysts (diameter of 1cm or greater). 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00834210). 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.