Mild to moderate acne-prone skin Skin and Connective Tissue Diseases Acne
Conditions
Interventions
The evaluated product is a cosmetic.
Group 1: only the cosmetic product applied twice per day
Group 2: cosmetic product applied once per day + concomitant treatment (according to the prescribing habi
Sponsors
ISISPHARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerance (cutaneous acceptability) by clinical examination under dermatological control at baseline, 42, 84, and 72 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Efficacy in reducing acne lesions and marks (red and brown) measured using dermatological scoring on days 0, 42, 84, and 112 2. Quality of life measured using the Cardiff Acne Disability Index (CADI) at days 0, 84 and 112 | — |
Countries
Romania
Contacts
Public ContactAmélie Clément
Outcome results
None listed