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

Completed

• Conditions: Acne

• Registration Number: NCT07107854
• Lead Sponsor: Cosmetique Active International

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2023-02-15
• Primary Completion: 2024-01-26
• Study Completion: 2024-01-26
• Study First Submitted: 2025-07-10
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-04
• Last Update Submitted: 2025-08-04
• Study First Posted: 2025-08-06
• Last Update Posted: 2025-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
comedogenic potential	kinetics: Day 0, Day 14, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6	comedogenic potential by counting the retentional and inflammatory lesions by the dermatologist in charge of the study;

Trial Locations

Locations (1)

PAŁUBICKA Joanna; 🇵🇱 Gdańsk, Poland