Comparison of the Efficacy of Clindamycin Phosphate 1% Gel Versus Once-daily Dapsone 5% Gel in the Treatment of Moderate Acne Vulgaris

Phase 2

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Clindamycin and Dapsone gel for 03 months

• Registration Number: NCT05926869
• Lead Sponsor: Jinnah Postgraduate Medical Centre

Brief Summary

Acne vulgaris (AV) is a disease of the pilosebaceous unit that causes noninflammatory lesions (open and closed comedones), inflammatory lesions (papules, pustules, and nodules), and varying degrees of scarring. The key pathogenic processes includes alteration of follicular keratinization that leads to comedones; increased and altered sebum production under androgen control; follicular colonization by Propionibacterium acnes; . The role of topical antibiotics in treating acne is well established. Clindamycin is a topical antibiotic which has been widely used in treatment of acne for many decades. The extensive use of antibiotics in acne has lead to the development of resistance to antimicrobial therapy. Dapsone is known to have antibacterial as well as anti-inflammatory action which may help in reduction of acne.

Detailed Description

Topical Dapsone 5% gel contains sulfone and has an advanced solvent micro particulate delivery system that enables penetration of stratum corneum . It is a new topical drug used in the treatment of Moderate Acne Vulgaris.

Study Timeline

• Study Start: 2022-08-01
• Primary Completion: 2022-12-01
• Study Completion: 2023-02-01
• Study First Submitted: 2023-03-22
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-23
• Last Update Submitted: 2023-06-23
• Study First Posted: 2023-07-03
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• moderate acne vulgaris
• either gender
• 20 to 50 yrs

Exclusion Criteria

• systemic treatment taken
• pregnant or lactating women
• hematological abnormalities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B Dapsone gel	Clindamycin and Dapsone gel for 03 months	-
Group A Clindamycin gel	Clindamycin and Dapsone gel for 03 months	-

Primary Outcome Measures

Name	Time	Method
Comparison of the Efficacy of Clindamycin Phosphate 1% Gel Versus Once-daily Dapsone 5% Gel in the Treatment of Moderate Acne Vulgaris	It will be assessed upto 03 months	Efficacy will be assessed using Global Acne Grading Sore ( GAGS ). For GAGS (Score 1-18 = mild, score 19-30 = moderate, score 31-38 = severe). Mean difference of GAGs score before and after the treatment will be calculated.

Trial Locations

Locations (1)

JPMC; 🇵🇰 Karachi, Sindh, Pakistan