Comparison of Topical Clascoterone and Adapalene for Mild Acne Vulgaris

NCT07673094 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 383/IREB/KTH
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

There is no local data available regarding the comparative efficacy of topical clascoterone and topical adapalene, particularly in patients with mild acne vulgaris. The findings of this study will help dermatologists identify the more effective topical treatment for mild acne vulgaris, leading to improved patient outcomes and better utilization of healthcare resources. Furthermore, the study will contribute local data to the existing literature and may assist in developing evidence-based treatment recommendations for patients with mild acne vulgaris in our setting. Patients meeting the inclusion criteria from the Dermatology Unit, Khyber Teaching Hospital, MTI, Peshawar will be incorporated into the study following approval from the ethics committee. At the commencement of the trial, baseline demographics including gender, age, height, weight, BMI, duration of acne, socioeconomic status, profession, monthly income, education level and residential status will be documented. An elaborate explanation of the process involved in the study will be provided to the participants, and consent will be taken following an explanation of the pros and cons involved. Randomization will be performed by computer generated random list. The group assignments will be put into sealed envelopes, which will be opened when the patient will be included in study. 30 patients will be in topical clascoterone group (A) while 30 patients will be in topical adapalene group (B). Patients allocated to Group A will receive topical clascoterone 1% cream. It is required that they will clean their faces using a mild cleansing agent, dry their faces and thereafter apply a thin coating of clascoterone 1% cream to their whole face area in the morning and evening for 12 consecutive weeks. Patients allocated to Group B will receive topical adapalene 0.1% gel. Patients will cleanse the skin using a gentle cleanser, allow it to dry in the air for 10 minutes, and then apply one pea-sized amount of 0.1% adapalene gel over their entire affected area of the face once a day before going to bed for 12 weeks.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

• IGA achievement

  investigator global assessment achievement of 0 which is clear face or 1 which is almost clear

  Baseline to 12 Weeks Participants will be assessed at baseline and at 12 weeks following initiation of treatment. Efficacy will be determined by the change in acne lesion counts and clinical improvement from baseline to week 12.

• Achievement of and IGA score of 0(clear) or 1(almost clear) after 12 weeks of treatment

  Investigator global assessment scoring

  Baseline to 12 Weeks Participants will be assessed at baseline and at 12 weeks following initiation of treatment. Efficacy will be determined by the change in acne lesion counts and clinical improvement from baseline to week 12.

Study Arms (2)

topical CLASCOTERONE 1 percent cream

EXPERIMENTAL

Drug: Clascoterone Cream 1%; Drug: Adapalene 0,1% cgel

Topical adapalene 0.1 percent gel

ACTIVE COMPARATOR

Drug: Clascoterone Cream 1%; Drug: Adapalene 0,1% cgel

Interventions

Clascoterone Cream 1% DRUG

Participants in this group will apply topical clascoterone 1% cream to the affected areas as prescribed for the duration of the study.

Topical adapalene 0.1 percent gel; topical CLASCOTERONE 1 percent cream

Adapalene 0,1% cgel DRUG

Participants in this group will apply topical adapalene 0.1% gel to the affected areas as prescribed for the duration of the study.

Topical adapalene 0.1 percent gel; topical CLASCOTERONE 1 percent cream

Eligibility Criteria

• Age: 12 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Clinical diagnosis of mild acne vulgaris as per operational definition
• Male or female patients
• Age 12 to 35 years

You may not qualify if:

• History of acne conglobata
• History of acne fulminans
• Use of topical anti-acne medications within the last 4 weeks
• Use of systemic anti-acne therapy within the last 12 weeks
• Known hypersensitivity or allergy to clascoterone or adapalene
• History of eczema
• History of rosacea
• History of seborrheic dermatitis
• History of psoriasis
• Presence of active skin infections
• Pregnant women
• Lactating women

Sponsors & Collaborators

• Khyber Teaching Hospital: lead

Related Publications (2)

• Morshed ASM, Noor T, Uddin Ahmed MA, Mili FS, Ikram S, Rahman M, Ahmed S, Uddin MB. Understanding the impact of acne vulgaris and associated psychological distress on self-esteem and quality of life via regression modeling with CADI, DLQI, and WHOQoL. Sci Rep. 2023 Nov 30;13(1):21084. doi: 10.1038/s41598-023-48182-6.

  PMID: 38030667 RESULT

• Vasam M, Korutla S, Bohara RA. Acne vulgaris: A review of the pathophysiology, treatment, and recent nanotechnology based advances. Biochem Biophys Rep. 2023 Nov 23;36:101578. doi: 10.1016/j.bbrep.2023.101578. eCollection 2023 Dec.

  PMID: 38076662 RESULT

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Haider Ali, MBBS,CHR

CONTACT

+923018078258; drhaider1001@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 29, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 22, 2027
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share