AcneNCT07107854
EVALUATION OF THE EFFICACY OF COSMETIC PRODUCT IN ADULTS SUBJECTS WITH MILD TO MODERATE ACNE
An observational study of Acne, run by Cosmetique Active International at 1 site in Poland.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- cosmetic: EFFACLAR ULTRA CONCENTRATED SERUM
- How many people
- 110 participants
- Where
- 1 sitePoland
- Study dates
- 15 Feb 2023to 26 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Acne
- Being tested
- cosmetic: EFFACLAR ULTRA CONCENTRATED SERUM
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cosmetic: EFFACLAR ULTRA CONCENTRATED SERUMOther
Transparent solution (gel)
What is being measured
The primary outcome is the main question the study is designed to answer.
comedogenic potential
comedogenic potential by counting the retentional and inflammatory lesions by the dermatologist in charge of the study;
Measured: kinetics: Day 0, Day 14, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start15 Feb 2023
- Primary completion26 Jan 2024
- Study completion26 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107854
- Sponsor's protocol ID
- 22E3856 / LRP 22027
- Status last verified
- Aug 2025
- First submitted
- 10 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE EFFICACY OF COSMETIC PRODUCT IN ADULTS SUBJECTS WITH MILD TO MODERATE ACNE - USE TEST UNDER DERMATOLOGICAL CONTROL - MULTICENTER STUDY
- ClinicalTrials.gov ID
- NCT07107854
- Acronym / sponsor ID
- 22E3856 / LRP 22027
- Conditions
- Acne
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Collaborators
- Eurofins
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 26 Jan 2024 (actual)
- Study completion
- 26 Jan 2024 (actual)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- Sex: female and male;
- Age: 20 years old and above;
- Type: Caucasian;
- Phototype: I to VI
- At least 10 subjects per phototype;
Key exclusion criteria (17 listed)
- Concerns woman: Pregnant or nursing woman or woman planning to get pregnant during the study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cosmetic: EFFACLAR ULTRA CONCENTRATED SERUMTransparent solution (gel) | Other | – |
Primary outcome
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;
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne, run by Cosmetique Active International at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comedogenic potential (time frame: kinetics: Day 0, Day 14, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.