RecruitingPhase 4NCT07102186

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

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.


Sponsor

Badr University

Enrollment

120 participants

Start Date

Jul 21, 2025

Study Type

INTERVENTIONAL

Conditions

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

Inclusion Criteria1

  • 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 Criteria1

  • patients with severe acne, nodulocystic acne, secondary infections, known hypersensitivity to adapalene or hyaluronic acid, pregnant, or lactating individuals.

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Interventions

DRUGuse of adapalene gel 0.1% and hyaluronic acid at bedtime

in this intervention a combination of adapalene gel 0.1% and hyaluronic acid will be used

DRUGuse of adapalene gel 0.1% once daily at bedtime

in this intervention involves the use of adapalene gel 0.1% once daily only topically at bedtime


Locations(1)

Badr university in Cairo

Cairo, Cairo Governorate, Egypt

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NCT07102186


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