CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Aczone Geldrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03681470
NCT03681470Phase 4Completed
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An Open-label Study to Investigate the Efficacy and Tolerability of Aczone Gel, 7.5% in the Treatment of Acne Vulgaris in Men and Women With Skin of Color

Icahn School of Medicine at Mount Sinai·interventional·Posted Sep 24, 2018·Updated Jul 27, 2022

In Brief

A Phase 4 clinical trial evaluating Aczone Gel for Acne Vulgaris. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Acne vulgaris is a common skin disease characterized by inflammatory papules, pustules, and comedones that is prevalent in men and women of color. Research has demonstrated that Aczone ® (dapsone) gel, 7.5% used once daily is effective, safe, and well-tolerated for the treatment of acne in both men and women; however, limited data is available regarding its efficacy and safety in skin of color (SOC). The current study aims to investigate the therapeutic impact of Aczone gel 7.5% in SOC males and females ages 18 and older with acne vulgaris. The study will also evaluate the impact of Aczone ® gel on hyperpigmentation and PIH of the face.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne Vulgaris
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedSep 24, 2018
Enrollment StartApr 9, 2019
Primary CompletionMay 6, 2021
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 7.8 years ago

Interventions

Aczone Geldrug

Aczone Gel 7.5%