Comparison of Topical Clascoterone 1% Cream Versus Adapalene 0.1% Cream in the Treatment of Mild-to-Moderate Acne Vulgaris

Acne vulgaris is a chronic inflammatory disorder of the pilosebaceous unit characterized by comedones, papules, and pustules. It commonly affects adolescents and young adults and may adversely affect quality of life. Clascoterone is a topical androgen receptor inhibitor that reduces androgen-mediated effects in the skin, whereas adapalene is a topical retinoid that acts on follicular keratinization and has anti-inflammatory properties.

This randomized controlled trial will compare topical clascoterone 1% cream with adapalene 0.1% cream in patients with mild-to-moderate acne vulgaris.

Study setting: The study will be conducted in the Dermatology Outpatient Department of Pak Emirates Military Hospital, Rawalpindi, Pakistan.

Study population and sample size: A total of 130 participants aged 12-55 years, of any gender, with clinically diagnosed mild-to-moderate acne vulgaris will be recruited using consecutive non-probability sampling, subject to the study eligibility criteria.

Study interventions: Participants will be randomly allocated using the draw method into two groups:

Group A: Clascoterone 1% cream (1gm) applied to the affected facial area twice daily.

Group B: Adapalene 0.1% cream applied to the affected facial area once daily at night.

Both groups will receive the same basic advice regarding gentle cleansing, appropriate moisturizer use, avoidance of picking or squeezing acne lesions, and daytime sunscreen use.

Study assessments: Baseline information will include age, sex, duration of acne, previous acne treatment, baseline acne severity, inflammatory lesion count, non-inflammatory lesion count, and total lesion count. Follow-up assessments will be conducted at Weeks 4, 8, and 12. a follow up visit at week 12 will be conducted to assess sustained response. The Investigator's Global Assessment (IGA) score, acne lesion counts, treatment compliance, adverse effects, patient satisfaction, and overall treatment efficacy will be recorded.

Outcome assessment: The treatment success endpoint will be assessed at Week 12. Treatment success is defined as an IGA score of 0 (clear) or 1 (almost clear), together with at least a two-grade improvement from baseline. The efficacy of the two treatment groups will be compared. Safety and tolerability will be evaluated by recording adverse effects, including erythema, dryness, scaling, burning, stinging, itching, and other reported treatment-related symptoms.

Statistical analysis: Data will be analyzed using SPSS version 29. Continuous variables will be summarized using means and standard deviations or medians and interquartile ranges, as appropriate. Categorical variables will be summarized using frequencies and percentages. The chi-square test will be used for comparison of categorical outcomes, with a p-value of less than 0.05 considered statistically significant.

Ethical considerations: Institutional ethical approval and the applicable research approvals will be obtained before recruitment. Written informed consent will be obtained from participants or their legally authorized representatives, as applicable. Confidentiality will be maintained, and participation will be voluntary.

• 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.

Primary outcomes

• Treatment success at week 12 [12 weeks after initiation of treatment]: Treatment success is defined as an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear), with at least a two-grade improvement from baseline at Week 12. The proportion of participants achieving treatment success will be compared between the clascoterone 1% cream and adapalene 0.1% cream groups.

Sex: All, ages: 12 Years to 55 Years

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.

• dr Zeshan akhtar, MBBS, Principal investigator, Pak Emiratres MIlitary Hospital Rawalpindi Pakistan