A study to assess the effects and safety of Sofinox Cream (Equivalent to Fusidic Acid 2.0% w/w) and Nicotinamide 3% w/w in volunteers with mild to moderate acne for 8 weeks
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Mild to Moderate Acne Vulgaris
- Registration Number
- CTRI/2013/10/004103
- Lead Sponsor
- Apex Laboratories Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 29
Inclusion Criteria
Male volunteers, aged 18-40 years
Skin phototype III-V (Fitzpatrick)
Subjects with mild to moderate facial acne vulgaris
Able to give written informed consent and to comply with the requirements of the study
Exclusion Criteria
Patients with any nodulo-cystic lesions at baseline
Secondary acne and severe acne (acne fulminans, acne Conglobata)
Patients with acne excoriata or having psychological disturbances
Subjects with underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy, such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Count of cutaneous inflammatory acne lesions <br/ ><br>- Average inflammatory lesion sizeTimepoint: Days 0 (day of inclusion), 14, 28, 42 and 56 <br/ ><br>
- Secondary Outcome Measures
Name Time Method - Self-evaluation questionnaire by the subjects at D0, D28 and D56 <br/ ><br>- Investigatorâ??s assessment of acne severity based on Leeds acne grading scale (Photographic scale) <br/ ><br>- Recurrence of target inflammatory acne lesions post subsidence <br/ ><br>- Skin conductivity with Corneometer® on days 0, 14, 28, 42 and 56 <br/ ><br>- Safety assessmentTimepoint: - Self-evaluation questionnaire by the subjects at D0, D28 and D56 <br/ ><br>- Investigatorâ??s assessment of acne severity based on Leeds acne grading scale (Photographic scale) <br/ ><br>- Recurrence of target inflammatory acne lesions post subsidence <br/ ><br>- Skin conductivity with Corneometer® on days 0, 14, 28, 42 and 56 <br/ ><br>- Safety assessment at days 0, 14, 28, 42 and 56