CompletedPhase 1/2

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

Indonesia23 participantsStarted 2024-11-30

Plain-language 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.

Who can participate

Age range15 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Clinical diagnosis of mild acne vulgaris, defined as fewer than 20 comedonal lesions, fewer than 15 inflammatory lesions, or a total lesion count of 30 or less, with a difference in total lesion count between the two sides of the face ≤ 5 lesions. * Minimum age of 15 years. * Indonesian individuals with Fitzpatrick skin types III-V. * Willing to participate in the study by signing an informed consent form. Exclusion Criteria: * History of routine application of topical agents containing active ingredients on the face within the past 2 weeks. * History of oral antibiotic use within the past 2 weeks. * History of systemic retinoid use within the past 3 months. * Currently pregnant or breastfeeding. * Using oral contraceptives at the time of assessment. * Presence of other dermatologic conditions on the face aside from acne vulgaris. * Having sensitive facial skin classified as rosacea-type, stinging-type, or allergic-type. * Unwilling to discontinue topical active agent therapy that has been used routinely for at least 2 weeks prior to study participation.

What they're measuring

Comparison of the percentage reduction in total acne lesions between the 0.025% tretinoin cream group and the 0.1% adapalene cream group

Timeframe: from enrollment to the end of treatment at 12 weeks

Trial details

NCT IDNCT07015931

SponsorIndonesia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-08