Adapalene gel plus hyaluronic acid versus adapalene alone for mild to moderate acne
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.
This test will see if adding a hyaluronic acid serum to nightly adapalene gel helps people with mild to moderate acne get fewer lesions and less irritation.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Sex | All |
| Sponsor | Badr University Academic / other |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Trial ID | NCT07102186 on ClinicalTrials.gov |
What this trial studies
This prospective, open-label, randomized controlled comparison enrolls patients with mild to moderate acne and randomizes them to adapalene 0.1% gel plus hyaluronic acid serum or adapalene 0.1% gel alone for 8 weeks. Participants must not have used topical retinoids or systemic acne treatments in the prior 3 months and will receive nightly applications with clinic follow-up. Primary efficacy outcomes include change in acne lesion counts and severity measured by the Acne Severity Index (ASI) and Investigator's Global Assessment (IGA), while safety outcomes record erythema, dryness, scaling, stinging/burning, and pruritus. Skin hydration will be assessed using a skin turgor test, with adherence and adverse events tracked at scheduled visits at Badr University in Cairo.
Who should consider this trial
Good fit: Ideal candidates are adolescents or adults with mild to moderate acne vulgaris who are not pregnant or lactating and who have not used topical retinoids or systemic acne treatments in the past 3 months.
Not a fit: Patients with severe or nodulocystic acne, active secondary skin infections, known hypersensitivity to adapalene or hyaluronic acid, or who are pregnant or breastfeeding are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the combination could reduce retinoid-related irritation, improve skin hydration, and help patients stay on effective acne treatment longer.
How similar studies have performed: Adapalene is a well-established topical retinoid and hyaluronic acid is known for hydrating and anti-inflammatory effects, but randomized comparisons of the combination versus adapalene alone are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * patients with severe acne, nodulocystic acne, secondary infections, known hypersensitivity to adapalene or hyaluronic acid, pregnant, or lactating individuals.
Where this trial is running
Cairo, Cairo Governorate
- Badr university in Cairo — Cairo, Cairo Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Hebatallah Moustafa, PhD
- Email: hebatallah.ahmed@buc.edu.eg
- Phone: 01001652500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.