EVALUATION OF THE EFFICACY OF COSMETIC PRODUCT IN ADULTS SUBJECTS WITH MILD TO MODERATE ACNE

EVALUATION OF THE EFFICACY OF COSMETIC PRODUCT IN ADULTS SUBJECTS WITH MILD TO MODERATE ACNE - USE TEST UNDER DERMATOLOGICAL CONTROL - MULTICENTER STUDY

EVALUATION OF THE EFFICACY OF COSMETIC PRODUCT IN ADULTS SUBJECTS WITH MILD TO MODERATE ACNE. USE TEST UNDER DERMATOLOGICAL CONTROL. THE STUDY CONDUCTED IN POLAND AND MAURITIUS

Claims:

• Improvement of acne
• Improvement of skin smoothness parameters

Objectives:

To evaluate:

• Its capacity to maintain the human face in good condition (cutaneous acceptability) by clinical examination under dermatological control;
• their comedogenic potential by counting the retentional and inflammatory lesions by the dermatologist in charge of the study;
• its smoothing effect by collecting polymer silicone skin's prints Silflo® and analysis using 3D Primos® Compact System
• its capacity to improve skin elasticity using cutometer®
• its capacity to maintain skin hydration using corneometer®
• its effect on the skin state by clinical scoring by the dermatologist in charge of the study;
• its effect on skin state by clinical auto scoring by the subjects;
• their anti-acne effect by GEA score and AFAST (score B) by the dermatologist in charge of the study;
• to illustrate their visual expected effect using ColorFace® and skincam®;
• to evaluate the change of subjects' quality of life questionnaire (AI-ADL) from baseline to D84 and D168;
• subjectively its cosmetic acceptability, properties, efficacy and future use by analysis of the subjects' answers to a subjective evaluation questionnaire

Inclusion Criteria:

- Sex: female and male;

• Age: 20 years old and above;
• Type: Caucasian;
• Phototype: I to VI
• At least 10 subjects per phototype;
• At least 5 subjects with GEA 3 per phototype;
• At least 2 males per phototype
• Subjects with mild to moderate acne (GEA 2-3);
• Subjects with at least 8 inflammatory lesions (full face);
• Subjects at least 20 non inflammatory lesions (full face). Healthy subject;
• Subject having given her/his free informed, web written consent;
• Subject willing to adhere to the protocol and study procedures.

Exclusion Criteria:

• Concerns woman: Pregnant or nursing woman or woman planning to get pregnant during the study;

  • Cutaneous pathology on the studied zone other than acne (eczema etc.);
  • Use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the acceptability and efficacy of the studied products (according to the investigator's appreciation);
  • Oral treatment of retinoids during the six previous months of the study;
  • Topical acne treatment since less than one month;
  • Acne with documented hormonal origin (e.g PCOS, hyperandrogenia of other origin).
  • Any change in hormonal treatment (including contraceptive) during the three previous months of the study or subject under Androcur®;
  • Subject under cyproterone-based or drospirenone medications (like Diane 35®, or Jasmine®, or Holgyème® or generic) treatments since less than six months;
  • Professional facial care during the previous month of the study;
  • Subject manipulating her acne lesions;
  • Subject with make-up on the day of the visit at the laboratory;
  • Excessive exposure to sunlight or UV-rays within the previous month;
  • Subject having undergone a surgery under general anesthesia within the previous month;
  • Subject enrolled in another clinical trial during the study period (concerns the studied zone);
  • Subject considered by the investigator to be likely not compliant to the protocol;
  • Subject enrolled in another clinical trial during the study period (concerns the studied zone);
  • Subject who does not meet the Ministry of Health guidelines for COVID-19 at time of the visit.