Evaluation of Topical Dutasteride as a Potential New Therapy for Facial Acne Vulgaris Versus the Triple Combination Therapy (Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel)

NCT07421804 | Not Yet Recruiting

• 1 other identifier: Topical dutasteride in AV
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Acne vulgaris (AV) is one of the most prevalent dermatological conditions worldwide, affecting approximately 85% of adolescents and young adults between the ages of 12 and 24 years .While acne is often self-limiting, it can have profound psychosocial implications as individuals with acne are more likely to experience emotional distress, lower self-esteem and anxiety disorders . Acne Vulgaris is a chronic inflammatory skin condition affecting the pilosebaceous units that leads to the development of different skin lesions such as comedones, papules, pustules, nodules and cystic lesions .

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

• Evaluate and compare the therapeutic efficacy (clinical, microbiological & psychological) of topical Dutasteride 0.05% versus topical fixed-dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% gel in patients with facial AV

  o Total lesions count (TLC) (inflammatory lesions and noninflammatory lesions)

  16 weeks

• Evaluate and compare the therapeutic efficacy (clinical, microbiological & psychological) of topical Dutasteride 0.05% versus topical fixed-dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% gel in patients with facial AV

  o The investigator's global assessment (IGA) of acne severity grade modified to assess the half-face acne severity ; Treatment success will be defined as an Investigator's Global Assessment score of 0 (clear) or 1 (almost clear), and a 2-grade or greater improvement from baseline at week 12.

  12 weeks

Secondary Outcomes (2)

• Addressing the safety profile of the two topical therapeutics

  12 weeks

• Psychological effect of AV and its relation to therapeutic outcomes

  12 weeks

Study Arms (2)

Topical Dutasteride 0.05% gel versus placebo (Petrolatum) (split face).

EXPERIMENTAL

Drug: topical dutasteride

Topical Dutasteride 0.05% gel versus topical triple fixed-dose combination

EXPERIMENTAL

Drug: topical dutasteride

Interventions

topical dutasteride DRUG

* Group I will be treated by topical Dutasteride 0.05% gel versus placebo (Petrolatum) (split face). * Group II will be treated by topical Dutasteride 0.05% gel versus topical triple fixed-dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% gel (split face).

Also known as: Dutasteride, Triple fixed combination

Topical Dutasteride 0.05% gel versus placebo (Petrolatum) (split face).; Topical Dutasteride 0.05% gel versus topical triple fixed-dose combination

Eligibility Criteria

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

You may qualify if:

• Patients with facial acne vulgaris older than 18 years.

You may not qualify if:

• · Unrealistic expectations.
• Unable to follow up.
• Severe and nodulocystic AV.
• Patients on topical treatment for AV (4 weeks before enrollment) and on systemic treatment for AV (3 months before enrollment).
• Patients on any systemic medication 3 months before enrollment.
• Suspicion of malignancy, including prostate cancer
• History of infertility or difficulty in fathering children.
• Pregnancy \& lactation.
• Planning to become pregnant during study period or 6 months after ending treatment
• Patients with any concomitant dermatologic or systemic illness.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (16)

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MeSH Terms

Conditions

Acne Vulgaris

Interventions

Dutasteride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Ola A Elminshawy, M.Sc.

CONTACT

+201112693230; ola-elminshawy@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 8, 2026
• First Posted: February 19, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share