Comparing the Efficacy and Safety of Adapalene Gel and Hyaluronic Acid Versus Adapalene Gel Alone in Mild to Moderate Acne Vulgaris: An Open-label Randomized Controlled Trial.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Patients with mild to moderate acne vulgaris who have not used topical retinoids or systemic acne treatments within the past 3 months will be included.

Locations
Other Locations
Egypt
Badr university in Cairo
RECRUITING
Cairo
Contact Information
Primary
Hebatallah Moustafa, PhD
hebatallah.ahmed@buc.edu.eg
01001652500
Time Frame
Start Date: 2025-07-21
Estimated Completion Date: 2025-10-21
Participants
Target number of participants: 120
Treatments
Active_comparator: adapalene gel 0.1% once daily at bedtime
Experimental: adapalene gel 0.1% once daily at bedtime and hyaluronic acid
Related Therapeutic Areas
Sponsors
Leads: Badr University

This content was sourced from clinicaltrials.gov