Actively Recruiting

Phase 4
All Genders
ID07102186

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

Led by Badr University · Updated on 2025-08-03

120

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Acne vulgaris is a common skin condition affecting about 85% of adolescents and young adults, often treated with topical retinoids like adapalene. This trial studies the effects of combining adapalene 0.1% gel with hyaluronic acid (HA) serum compared to adapalene alone in patients with mild to moderate acne. The goal is to see if the combination reduces acne lesions and lessens side effects such as redness, dryness, scaling, stinging, burning, and itching while improving skin hydration. The study is an open-label, randomized controlled trial lasting 8 weeks. Participants are divided into two groups: one uses adapalene 0.1% gel nightly with HA serum, and the other uses adapalene gel alone at bedtime. Assessments occur at the start and at weeks 2, 4, and 8 to monitor treatment effects, side effects, and skin hydration. During the trial, acne severity is measured with the Acne Severity Index and Investigator's Global Assessment scale, while skin hydration is evaluated using the skin turgor test. Side effects are scored for severity at each visit. Researchers aim to determine if the combination therapy improves acne outcomes and reduces irritation. All participants will provide informed consent, and data confidentiality is maintained throughout the study.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with mild to moderate acne vulgaris
  • No use of topical retinoids or systemic acne treatments within the past 3 months
Not Eligible

You will not qualify if you...

  • Severe acne or nodulocystic acne
  • Secondary skin infections
  • Known allergy to adapalene or hyaluronic acid
  • Pregnant or lactating individuals

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 8 weeks

Participants use adapalene gel 0.1% once daily at bedtime, either alone or combined with hyaluronic acid, to treat mild to moderate acne vulgaris.

Visits at baseline, Week 2, Week 4, and Week 8

Trial Site Locations

Total: 1 location

1

Badr university in Cairo

Cairo, Cairo Governorate, Egypt, 11829

Actively Recruiting

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Research Team

H

Hebatallah Moustafa, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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