Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03681470 · ClinicalTrials.gov registry record · Phase 4
Aczone Gel 7.5% in the Treatment of Acne Vulgaris in Patients With Skin of Color
A Phase 4 study of Acne Vulgaris, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT03681470: Completed Phase 4 study of Acne Vulgaris, sponsored by Icahn School of Medicine at Mount Sinai.
NCT03681470 is a Phase 4 study of Acne Vulgaris that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 20 participants, below the 275-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03681470, a Phase 4 study of Acne Vulgaris, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
GAAS assesses acne severity on a 5-point score: 0 - None: No evidence of facial acne vulgaris. 1. \- Minimal: Few noninflammatory lesions are present; a few inflammatory lesions (papules/pustules) may be present; no nodulo-cystic lesions present. 2. \- Mild: Several to many noninflammatory lesions are present; a few inflammatory lesions are present; no nodulo-cystic lesions present. 3. \- Moderate: Many noninflammatory and inflammatory lesions are present; no nodulo-cystic lesions are present.
Conditions Studied
Interventions
- DRUG Aczone Gel
Study Locations (1)
New York
- Mount Sinai West - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-04-09 |
| Est. Completion | 2021-05-06 |
| Phase | Phase 4 |
What the finished NCT03681470 record still lists
NCT03681470 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 275-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Acne Vulgaris appearing as the primary indexed condition, and to 1 intervention - of which Aczone Gel is the first listed.
NCT03681470 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03681470 about?
NCT03681470 is a clinical study titled "Aczone Gel 7.5% in the Treatment of Acne Vulgaris in Patients With Skin of Color". 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 ...
What is the current status of trial NCT03681470?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2019-04-09. Estimated completion is 2021-05-06.
What conditions does trial NCT03681470 study?
This clinical trial studies the following conditions: Acne Vulgaris.
What interventions are being tested in trial NCT03681470?
The interventions under investigation include: Aczone Gel (DRUG).
Who is sponsoring clinical trial NCT03681470?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03681470 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acne Vulgaris
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03681470's enrollment target sits among peer trials
20 62nd of 67 higher than 5 of 67 other Acne Vulgaris trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acne Vulgaris trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Assess Sebaceous Gland Changes and Constituents of Sebum (Skin Oil) Induced by Clascoterone 1% Cream in Acne Patients
ACTIVE NOT RECRUITING · Phase 4
-
Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris
COMPLETED · Phase 4
-
AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation
COMPLETED · Phase 4
-
A Study to Compare Efficacy and Safety of Trifarotene Cream When Used With an Oral Antibiotic for the Treatment of Severe Acne Vulgaris (AV)
COMPLETED · Phase 4
-
Pharmacokinetic Study to Compare the Systemic Exposure of Differin® Gel, 0.3% or Differin® Gel, 0.1%
COMPLETED · Phase 4
-
Compare the Tolerance of Clindamycin 1% /Benzoyl Peroxide (BPO) 5% Gel to Clindamycin 1.2%/ BPO 2.5% Topical Medications
COMPLETED · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00573339 · 20 participants
Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing
- NCT00692939 · 20 participants · Phase 1
Autologous Stem Cell Transplantation for Crohn's Disease
- NCT00967785 · 20 participants · Phase 1
A Phase I Study of Mozobil in the Treatment of Patients With WHIMS
- NCT01406691 · 20 participants · Phase 4
Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI