NCT07392047

Metronidazole 2% Gel Versus Clindamycin 1% Gel for Moderate Acne Vulgaris

Comparison Of The Efficacy Of 2% Metronidazole Gel Versus 1% Clindamycin Gel In The Treatment Of Moderate Acne Vulgaris

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Jinnah Postgraduate Medical Centre · Other Government
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

Acne vulgaris is a common inflammatory skin disorder. This randomized controlled trial (RCT) will compare the efficacy and safety of 2% metronidazole gel versus 1% clindamycin gel in adults with moderate acne vulgaris at Jinnah Postgraduate Medical Centre (JPMC), Karachi. Sixty eligible participants (18-35 years) will be enrolled using consecutive sampling and randomized in a 1:1 ratio using blocked randomization. Participants will apply the assigned gel as a thin layer twice daily for 12 weeks. Acne severity will be assessed using the Modified Global Acne Grading System (mGAGS) at baseline and at weeks 4, 8, and 12. The primary outcome is the proportion of participants achieving at least a 50% reduction from baseline in total mGAGS score at week 12. Local adverse effects (e.g., erythema, itching, irritation) will be recorded at each follow-up visit.

Detailed description

This is an investigator-initiated, parallel-group randomized controlled trial (RCT) conducted in the Department of Dermatology, Jinnah Postgraduate Medical Centre (JPMC), Karachi. After approval from the Institutional Review Board (IRB) and the College of Physicians and Surgeons Pakistan (CPSP), adults aged 18-35 years with moderate acne vulgaris, defined by a Modified Global Acne Grading System (mGAGS) score of 45-80, and not using other anti-acne therapies will be enrolled using non-probability consecutive sampling. Participants who are pregnant or lactating, have severe acne (mGAGS \>80), have a known allergy to metronidazole or clindamycin, or have other dermatologic conditions affecting the face will be excluded. Participants will be randomized in a 1:1 allocation using blocked randomization to receive either metronidazole 2% gel or clindamycin 1% gel. The assigned treatment will be applied as a thin layer twice daily (morning and night) for 12 weeks after gentle cleansing and drying of the face. Concomitant anti-acne products will be discouraged during the intervention period. Follow-up assessments will occur at weeks 4, 8, and 12. At each visit, acne severity will be assessed using mGAGS, and tolerability will be evaluated by recording local adverse effects, including erythema, itching, dryness, burning, or irritation. The primary endpoint is treatment response at week 12, defined as a ≥50% reduction in total mGAGS score from baseline. Participants will be classified as responders (≥50% reduction) or non-responders (\<50% reduction). Data will be analyzed using Statistical Package for the Social Sciences (SPSS) version 26. Categorical outcomes will be compared using the chi-square test or Fisher's exact test, and continuous variables will be compared using the independent-samples t test or Mann-Whitney U test according to data distribution. Stratified analyses will explore effect modification by age and sex. A two-sided p value ≤0.05 will be considered statistically significant.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Metronidazole Topical Gel 2%	Topical metronidazole gel 2% applied as a thin layer to affected areas twice daily (morning and night) for 12 weeks after gentle cleansing and drying.
DRUG	Clindamycin Topical Gel 1%	Topical clindamycin gel 1% applied as a thin layer to affected areas twice daily (morning and night) for 12 weeks after gentle cleansing and drying.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2026-02-06
• Last updated: 2026-02-06