Study on the tolerance and efficiency of a dermo-cosmetic product for mild to moderate acne in combination or comparison to current treatments in Romania
- Conditions
- Mild to moderate acne-prone skinSkin and Connective Tissue DiseasesAcne
- Registration Number
- ISRCTN70142596
- Lead Sponsor
- ISISPHARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 90
1. Sex: female and/or male
2. Subject having given his/her informed written consent or parental authorization
3. Subject willing to adhere to the protocol and study procedures
Specific criteria:
1. Healthy subject with acne-prone skin: grade 2 or 3 (Global Acne Evaluation [GEA] scale) and with at least 10 inflammatory lesions
2. Group 2 and 3: Beginning an anti-acne treatment (zinc orally, antibiotic orally, contraceptive or hormonal treatment, topical retinoid or a combination)
1. Excluding treatment:
1.1. Epiduo® or combination of benzoyl peroxide (BPO) + Adapalene
1.2. Oral isotretinoin
1.3. Chronically used anti-inflammatory drugs
2. Subject manipulating his/her acneic lesions
3. Any change in hormonal treatment (including contraceptives) during the three previous months of the study
4. Cutaneous pathology on the study zone (eczema, etc)
5. Excessive exposure to sunlight or UV rays within the previous month
6. Subject enrolled in another clinical trial during the study period
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tolerance (cutaneous acceptability) by clinical examination under dermatological control at baseline, 42, 84, and 72 days
- Secondary Outcome Measures
Name Time Method 1. Efficacy in reducing acne lesions and marks (red and brown) measured using dermatological scoring on days 0, 42, 84, and 112<br>2. Quality of life measured using the Cardiff Acne Disability Index (CADI) at days 0, 84 and 112