NCT07102186 Efficacy and Safety of Adapalene Gel and Hyaluronic Acid Versus Adapalene Gel Alone in Mild to Moderate Acne Vulgaris
| NCT ID | NCT07102186 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Badr University |
| Condition | Acne Vulgaris |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-07-21 |
| Primary Completion | 2025-10-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2025-07-21 with a primary completion date of 2025-10-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07102186 clinical trial?
This trial is open to participants of all sexes, studying Acne Vulgaris. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07102186 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07102186 currently recruiting?
Yes, NCT07102186 is actively recruiting participants. Contact the research team at hebatallah.ahmed@buc.edu.eg for enrollment information.
Where is the NCT07102186 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT07102186 clinical trial?
NCT07102186 is sponsored by Badr University. The trial plans to enroll 120 participants.