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Comparison of Topical Clascoterone 1% Cream Versus Adapalene 0.1% Cream in the Treatment of Mild-to-Moderate Acne Vulgaris: A Randomized Controlled Trial

Sponsor: Pak Emirates Military Hospital • ClinicalTrials.gov ID: NCT07883538

Registry updated: 2026-10-20

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Description

This study will compare the effectiveness and safety of topical clascoterone 1% cream and adapalene 0.1% cream in patients with mild-to-moderate acne vulgaris. Acne is a common skin condition that causes blackheads, whiteheads, pimples, and inflammation. A total of 130 eligible participants aged 12-40 years will be enrolled in a randomized controlled trial at the Dermatology Outpatient Department of Pak Emirates Military Hospital, Rawalpindi, Pakistan. Participants will be randomly assigned to one of two treatment groups. Group A will receive clascoterone 1% cream applied twice daily, while Group B will receive adapalene 0.1% cream applied once daily at night. Treatment will continue for 12 weeks. Participants will be assessed at baseline and during follow-up visits at Weeks 4, 8, and 12. Treatment response will be evaluated using the Investigator's Global Assessment (IGA) score and acne lesion counts. Treatment success will be defined as an IGA score of 0 (clear) or 1 (almost clear), with at least a two-grade improvement from baseline at Week 12. Adverse effects, treatment compliance, and patient satisfaction will also be assessed. The study aims to compare the efficacy and tolerability of both treatments in patients with mild-to-moderate acne vulgaris.

Interventions

Clascoterone 1% cream (Drug)
Clascoterone 1% cream applied topically to the affected facial area twice daily for 12 weeks. Participants will receive standard advice regarding gentle cleansing, moisturizer use, avoidance of picking or squeezing acne lesions, and daytime sunscreen use.
Adapalene 0.1% cream (Drug)
Adapalene 0.1% cream applied topically to the affected facial area once daily at night for 12 weeks. Participants will receive the same standard advice regarding gentle cleansing, moisturizer use, avoidance of picking or squeezing acne lesions, and daytime sunscreen use.

Eligibility criteria

Inclusion Criteria: 1. Patients with clinically diagnosed mild-to-moderate acne vulgaris. 2. Patients willing to use the assigned treatment and attend scheduled follow-up visits. 3. Any gender between the ages of 12 and 55. Exclusion Criteria: 1. Acne-like eruptions caused by drugs or another identifiable condition. 2. Recent topical or systemic anti-acne treatment that may affect assessment of the study treatment. 3. Pregnancy or breastfeeding as both these treatments are contraindicated. 4. Known allergy or hypersensitivity to clascoterone, adapalene or their formulation components.

Conditions

Acne Vulgaris

Locations

Pak Emirates Military Hospital — Rawalpindi, Punjab Province, Pakistan

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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