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

NCT ID: NCT07102186

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-21
• Study Completion Date: 2025-10-21

Brief 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.

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

adapalene gel 0.1% once daily at bedtime

Group Type: ACTIVE_COMPARATOR

use of adapalene gel 0.1% once daily at bedtime

Intervention Type: DRUG

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

adapalene gel 0.1% once daily at bedtime and hyaluronic acid

Group Type: EXPERIMENTAL

use of adapalene gel 0.1% and hyaluronic acid at bedtime

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Badr University

OTHER

Sponsor Role: lead

Responsible Party

Hebatallah Ahmed Mohamed Moustafa

Assistant professor in the clinical pharmacy and pharmacy practice department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Badr university in Cairo

Cairo, Cairo Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Hebatallah Moustafa, PhD

Role: CONTACT

hebatallah.ahmed@buc.edu.eg

01001652500

Facility Contacts

Hebatallah Moustafa

Role: primary

hebatallah.ahmed@buc.edu.eg

01001652500

Other Identifiers

BUC-IACUC-241117-119

Identifier Type: -

Identifier Source: org_study_id