Clinical Trial

Efficacy and Safety of Adapalene Gel and Hyaluronic Acid Versus Adapalene Gel Alone in Mild to Moderate Acne Vulgaris

Recruiting Phase 4
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Record status
This record was last updated August 3, 2025 (before its estimated October 21, 2025 completion). Its status may not reflect the trial's current state.
Summary
Acne vulgaris affects around 85% of adolescents and young adults. Adapalene, a topical retinoid, is a common treatment but often causes irritation, leading to poor adherence. Hyaluronic acid (HA), known for its hydrating and anti-inflammatory properties, may help reduce these side effects. This prospective, open-label, randomized controlled trial compares adapalene 0.1% gel combined with HA serum versus adapalene alone over 8 weeks in patients with mild to moderate acne. Key outcomes include acne lesion reduction, incidence and severity of side effects (erythema, dryness, scaling, stinging/burning, pruritus), and skin hydration assessed through the skin turgor test. Acne severity will be measured using the Acne Severity Index (ASI) and Investigator's Global Assessment (IGA) scale. The study anticipates better efficacy, reduced irritation, and improved skin hydration with the combination therapy. Ethical approval was obtained, and informed consent will be secured from all participants.
Trial Details
NCT Number NCT07102186
Lead Sponsor Badr University
Conditions Acne Vulgaris
Enrollment 120 participants
Start Date 2025-07-21
Primary Completion 2025-10-21 (estimated)
Study Completion 2025-10-21 (estimated)
Updated on ClinicalTrials.gov 2025-08-03