Effectiveness of niosomal clindamycin solution in treatment of acne
Phase 2
- Conditions
- acne vulgaris.Acne vulgaris
- Registration Number
- IRCT2017080635524N1
- Lead Sponsor
- Vice Chancellor for research of Kerman University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Mild to moderate acne vulgaris; Both male and female;age (12-30years); lack of treatment during the one month period before the study
exclusion criteria: pregnancy; breast feeding; hypersensitivity to clindamycin; history of inflamatory bowel disease(IBD); history of neuromuscular junction blocker using; history of systemic retinoid using in the past 6 month; history of oral estrogen using in the past 3 month; history of topical retinoid and oral antibiotic using in the past 1 month; history of antimicrobial soap and comedogenic products using in the past 2 weeks; history of astringents and abrasive products using in the past 1 week; hirsutism; androgenetic alopecia; Polycystic ovarian syndrome.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Acne severity. Timepoint: Baseline, two weeks after intervention ,four weeks after intervention, eight weeks after intervention, twelve weeks after intervention. Method of measurement: Inflammatory and non-inflammatory lesions count, mild acne: most non-inflammatory lesions or less than 15 inflammatory lesions, moderate acne: 15 to 50 inflamatory lesions.;Acne grading. Timepoint: Baseline, two weeks after intervention ,four weeks after intervention, eight weeks after intervention, twelve weeks after intervention. Method of measurement: Global Acne Grading system: The face is divided into five parts, forehead(2 factor), right and left cheek(2 factor), nose(1 factor), chin(1 factor), no lesions = 0, comedones = 1, papules = 2, pustules = 3 and nodules = 4. The score for each area (Local score) is calculated using the formula: Local score = Factor × Grade (0-4). The global score is the sum of local scores.
- Secondary Outcome Measures
Name Time Method Erythema. Timepoint: Baseline, two weeks after intervention ,four weeks after intervention, eight weeks after intervention, twelve weeks after intervention. Method of measurement: Inspection.;Pruritus. Timepoint: Baseline, two weeks after intervention ,four weeks after intervention, eight weeks after intervention, twelve weeks after intervention. Method of measurement: Questionnaire.;Scaling. Timepoint: Baseline, two weeks after intervention ,four weeks after intervention, eight weeks after intervention, twelve weeks after intervention. Method of measurement: Inspection.