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

August 4, 2025 updated by: Cosmetique Active International

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
comedogenic potential
Time Frame: 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;
kinetics: Day 0, Day 14, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cosmetique Active International

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eurofins

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 26, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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