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

ConditionAcne Vulgaris

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-35

SponsorJinnah Postgraduate Medical Centre

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Metronidazole Topical Gel 2%
Drug
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.
Clindamycin Topical Gel 1%
Drug
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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Metronidazole 2% GelExperimental treatment 1 intervention

Group B: Clindamycin 1% GelActive comparator 1 intervention

Trial outcomes

Primary outcomes

Treatment response by mGAGS at Week 12

Proportion of participants achieving ≥50% reduction in total Modified Global Acne Grading System (mGAGS) score from baseline (Responder = Yes; Non-responder = No).

Time frame

12 weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jinnah Postgraduate Medical Centre

Lead sponsor

Source ClinicalTrials.gov

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