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

NCT07102186 | Recruiting Phase 4

• 1 other identifier: BUC-IACUC-241117-119
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Keywords

acne vulgaris; adapalene; Hyaluronic acid; Topical Retinoids

Outcome Measures

Primary Outcomes (1)

• Local tolerance to the drugs scale

  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 Outcomes (3)

• investigator's global assessment (IGA)

  8 weeks

• acne severity index

  8 weeks

• skin turgor assessment

  8 weeks

Study Arms (2)

adapalene gel 0.1% once daily at bedtime

ACTIVE COMPARATOR

Drug: use of adapalene gel 0.1% once daily at bedtime

adapalene gel 0.1% once daily at bedtime and hyaluronic acid

EXPERIMENTAL

Drug: use of adapalene gel 0.1% and hyaluronic acid at bedtime

Interventions

use of adapalene gel 0.1% and hyaluronic acid at bedtime DRUG

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

adapalene gel 0.1% once daily at bedtime and hyaluronic acid

use of adapalene gel 0.1% once daily at bedtime 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Badr University: lead

Study Sites (1)

Badr university in Cairo

Cairo, Cairo Governorate, 11829, Egypt

RECRUITING

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Central Study Contacts

Hebatallah Moustafa, PhD

CONTACT

01001652500; hebatallah.ahmed@buc.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor in the clinical pharmacy and pharmacy practice department

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 3, 2025
• Study Start: July 21, 2025
• Primary Completion: October 21, 2025
• Study Completion: October 21, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 21-7-2025 till 21-10-2025
• Access Criteria: data will be available via the main investigator, email: hebatallah.ahmed@buc.edu.eg

Locations

EG (1)