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

July 28, 2025 updated by: Hebatallah Ahmed Mohamed Moustafa, Badr University

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Acne vulgaris is a prevalent dermatological condition affecting approximately 85% of adolescents and young adults. Topical retinoids, such as adapalene, are considered a first-line treatment for mild to moderate acne due to their comedolytic, anti-inflammatory, and keratolytic properties. However, retinoid-associated irritation, including dryness, erythema, and peeling, often leads to poor adherence and treatment discontinuation.

Hyaluronic acid (HA), a naturally occurring glycosaminoglycan, is well known for its hydrating and anti-inflammatory properties. When combined with adapalene, it may improve patient adherence by reducing retinoid-induced irritation while maintaining or enhancing the therapeutic effects. While previous studies have assessed individual efficacy, there is a lack of direct comparative studies evaluating the combination of adapalene with hyaluronic acid versus adapalene alone in treating mild to moderate acne vulgaris.

The aim of this study is to compare the reduction in acne lesion count between adapalene and hyaluronic acid versus adapalene alone over 8 weeks, to evaluate differences in treatment-related adverse effects such erythema, scaling, dryness, stinging or burning, and pruritus, and to determine overall skin hydration.

This is a prospective, open-label, randomized controlled trial conducted at a dermatology clinic. Patients will be randomized into two groups: (1) adapalene 0.1% gel + hyaluronic acid serum and (2) adapalene 0.1% gel alone. The study duration will be 8 weeks with assessments at baseline and the 2nd, 4th, and 8th weeks. 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 include patients with severe acne, nodulocystic acne, secondary infections, known hypersensitivity to adapalene or hyaluronic acid, pregnant, or lactating individuals.

The acne severity index (ASI) will be assessed at baseline and at the end of the study to evaluate acne severity, considering both lesion count and distribution. The investigator's global assessment (IGA) clinical tool will be used at baseline and every 2 weeks thereafter to assess the severity of acne and monitor treatment response. It is a 5-point ordinal scale that evaluates the overall severity of acne based on lesion count, type, and inflammation. The skin turgor test will be used to assess skin hydration and the time it takes for the skin to return to its original position is observed (> 2 seconds: moderate to severe dehydration, <2 seconds, but not immediately: mild dehydration, and immediately: absent dehydration). Local tolerance to the drugs will be evaluated by using the score: 0-none; 1-mild; 2-moderate; 3-severe for erythema, scaling, dryness, stinging or burning, and pruritus at each follow-up visit.

The investigators expect a greater reduction in acne lesion counts, a lower incidence and severity of retinoid-associated irritation, and an improved skin hydration with combination therapy. Institutional Review Board (IRB) approval was obtained before initiating data collection (BUC-IACUC-241117-119). Data confidentiality will be ensured through secure storage and anonymization. Written informed consent will be obtained from all participants.

This study aims to provide clinical evidence supporting the role of hyaluronic acid in enhancing the efficacy and tolerability of adapalene in acne treatment, potentially improving patient outcomes and tolerance.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: adapalene gel 0.1% once daily at bedtime
Drug: use 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
Experimental: adapalene gel 0.1% once daily at bedtime and hyaluronic acid
Drug: use 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local tolerance to the drugs scale
Time Frame: 8 weeks
Local tolerance to the drugs will be evaluated by using the score: 0-none; 1-mild; 2-moderate; 3-severe for erythema, scaling, dryness, stinging or burning, and pruritus at each follow-up visit. The higher the score the lower the tolerance to the drugs. Minimum score is zero and maximum score is 15.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
investigator's global assessment (IGA)
Time Frame: 8 weeks
investigator's global assessment (IGA) clinical tool will be used at baseline and every 2 weeks thereafter to assess the severity of acne and monitor treatment response. It is a 5-point ordinal scale that evaluates the overall severity of acne based on lesion count, type, and inflammation. Only patients with score of 2 (mild) or 3 (moderate) will be enrolled and followed up
8 weeks
acne severity index
Time Frame: 8 weeks
The acne severity index (ASI) will be assessed at baseline and at the end of the study to evaluate acne severity, considering both lesion count and distribution.The higher the score the poorer the outcomes. Minimum score is zero.
8 weeks
skin turgor assessment
Time Frame: 8 weeks
The skin turgor test will be used to assess skin hydration and the time it takes for the skin to return to its original position is observed (> 2 seconds: moderate to severe dehydration, <2 seconds, but not immediately: mild dehydration, and immediately: absent dehydration).
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Badr University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2025

Primary Completion (Estimated)

October 21, 2025

Study Completion (Estimated)

October 21, 2025

Study Registration Dates

First Submitted

July 21, 2025

First Submitted That Met QC Criteria

July 28, 2025

First Posted (Actual)

August 3, 2025

Study Record Updates

Last Update Posted (Actual)

August 3, 2025

Last Update Submitted That Met QC Criteria

July 28, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUC-IACUC-241117-119

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

study protocol and informed consent form

IPD Sharing Time Frame

21-7-2025 till 21-10-2025

IPD Sharing Access Criteria

data will be available via the main investigator, email: hebatallah.ahmed@buc.edu.eg

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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