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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
Phase 1, PHASE2 trial testing retinoic acid cream 0.025% in Acne Vulgaris in 23 participants. Completed in 15 March 2025.
8 March 2025
Quick facts
| Lead sponsor | Indonesia University |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 23 |
| Start date | 30 November 2024 |
| Primary completion | 8 March 2025 |
| Estimated completion | 15 March 2025 |
| Sites | 1 location across Indonesia |
Drugs / interventions tested
- retinoic acid cream 0.025% — full drug profile →
- adapalene cream 0.1% — full drug profile →
Conditions studied
- Acne Vulgaris — all drugs for Acne Vulgaris →
Sponsor
Indonesia University
Who can join
15 and older, any sex, with Acne Vulgaris. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07015931
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07015931 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Indonesia University
- Last refreshed: 11 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07015931.
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