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

NCT07107854 | Completed

• 1 other identifier: 22E3856 / LRP 22027
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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

Conditions

Acne

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

cosmetic: EFFACLAR ULTRA CONCENTRATED SERUM OTHER

Transparent solution (gel)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Cosmetique Active International: lead
• Eurofins: collaborator

Study Sites (1)

PAŁUBICKA Joanna

Gdansk, Gdańsk, 80-288, Poland

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: August 6, 2025
• Study Start: February 15, 2023
• Primary Completion: January 26, 2024
• Study Completion: January 26, 2024
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)