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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Clindamycin and Dapsone gel for 03 months


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: moderate acne vulgaris either gender 20 to 50 yrs Exclusion Criteria: systemic treatment taken pregnant or lactating women hematological abnormalities

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A Clindamycin gel<br> | Drug: Clindamycin and Dapsone gel for 03 months<br>* Clindamycin is a topical antibiotic which has been widely used in treatment of acne for many decades. 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. It has antibacterial as well as anti inflammatory effects<br>|
| Experimental: Group B Dapsone gel<br> | Drug: Clindamycin and Dapsone gel for 03 months<br>* Clindamycin is a topical antibiotic which has been widely used in treatment of acne for many decades. 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. It has antibacterial as well as anti inflammatory effects<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the Efficacy of Clindamycin Phosphate 1% Gel Versus Once-daily Dapsone 5% Gel in the Treatment of Moderate Acne Vulgaris | 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. | It will be assessed upto 03 months |