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Efficacy, Safety Profile, and Post-Acne Sequelae of 0.025% Retinoic Acid Cream vs. 0.1% Adapalene Cream in Mild Acne Vulgaris in Fitzpatrick Skin Types III-V

NCT07015931 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-06-11

No results posted yet for this study

Summary

The goal of this clinical trial is to compare the effectiveness, safety profile, and post-acne sequelae of 0.025% retinoic acid cream versus 0.1% adapalene cream for mild acne vulgaris in individuals with Fitzpatrick skin types III-V.

Main research questions are:

1. How does 0.025% retinoic acid cream compare to 0.1% adapalene cream in reducing the total number of acne lesions in patients with mild acne vulgaris and Fitzpatrick skin types III-V?
2. What is the severity of adverse effects that occur on the facial side treated with 0.1% adapalene cream and the facial side treated with 0.025% retinoic acid cream in patients with mild acne vulgaris and Fitzpatrick skin types III-V?
3. What is the severity of post-inflammatory hyperpigmentation (PIH) that occurs on the facial side treated with 0.1% adapalene cream and the facial side treated with 0.025% retinoic acid cream in patients with mild acne vulgaris and Fitzpatrick skin types III-V?
4. What is the severity of post-acne erythema (PAE) that occurs on the facial side treated with 0.1% adapalene cream and the facial side treated with 0.025% retinoic acid cream in patients with mild acne vulgaris and Fitzpatrick skin types III-V?
5. What is the quantity, type, and severity of post-acne scarring (PAS) that occurs on the facial side treated with 0.1% adapalene cream and the facial side treated with 0.025% retinoic acid cream in patients with mild acne vulgaris and Fitzpatrick skin types III-V?

Participants will:

* Undergo baseline assessments, including acne lesion count, hyperpigmentation index, Clinician Erythema Assessment (CEA) scale, and post-acne scarring grading on each facial side.
* Apply 0.025% retinoic acid cream and 0.1% adapalene cream on different facial sides as per randomization, every night for 12 weeks.
* Record daily adverse effects per facial side, lesion manipulation frequency, and sun exposure duration
* Attend follow-up visits every 4 weeks for acne lesion count, hyperpigmentation index, CEA scale, post-acne scarring grading, and assessment of adverse effect severity.

Conditions

  • Acne Vulgaris

Interventions

DRUG

retinoic acid cream 0.025%

half finger tip unit

DRUG

adapalene cream 0.1%

half finger tip unit

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-30
Primary Completion
2025-03-08
Completion
2025-03-15

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07015931 on ClinicalTrials.gov