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Clinical trial

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

ID
Name
NO.F.2-81/2022-GENL/250/JPMC
Description
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.
Trial arms
Trial start
2022-08-01
Estimated PCD
2022-12-01
Trial end
2023-02-01
Status
Completed
Phase
Early phase I
Treatment
Clindamycin and Dapsone gel for 03 months
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
Arms:
Group A Clindamycin gel, Group B Dapsone gel
Size
100
Primary endpoint
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
Eligibility criteria
Inclusion Criteria: * moderate acne vulgaris * either gender * 20 to 50 yrs Exclusion Criteria: * systemic treatment taken * pregnant or lactating women * hematological abnormalities
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}
Updated at
2023-07-03

1 organization

1 product

1 indication

Organization
Jinnah Postgraduate Medical Centre
Product
Clindamycin and Dapsone Gel
Indication
Acne Vulgaris