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

Study Overview

• Status: Completed
• Conditions: Acne
• Intervention / Treatment: Other: cosmetic: EFFACLAR ULTRA CONCENTRATED SERUM

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 Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• Poland
  • Gdańsk, Poland, 80-288
    • PAŁUBICKA Joanna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cosmetique Active International
• Collaborators: Eurofins

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Actual): January 26, 2024
• Study Completion (Actual): January 26, 2024

Study Registration Dates

• First Submitted: July 10, 2025
• First Submitted That Met QC Criteria: August 4, 2025
• First Posted (Actual): August 6, 2025

Study Record Updates

• Last Update Posted (Actual): August 6, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: 22E3856 / LRP 22027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No