NCT07015931

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

Efficacy of 0.025% Retinoic Acid Cream Compared to 0.1% Adapalene Cream on Mild Acne Vulgaris, as Well as Safety Profile and Post-Acne Sequelae in Fitzpatrick Skin Types III-V: A Randomized Double-Blind Clinical Trial Using the Split-Face Method

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	retinoic acid cream 0.025%	half finger tip unit
DRUG	adapalene cream 0.1%	half finger tip unit

Timeline

• Start date: 2024-11-30
• Primary completion: 2025-03-08
• Completion: 2025-03-15
• First posted: 2025-06-11
• Last updated: 2025-06-11

Locations

1 site across 1 country: Indonesia