Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-25 @ 5:06 AM
NCT ID:
NCT06770127
Eligibility Criteria:
Inclusion Criteria:
* Fitzpatrick skin phototype: III to VI;
* Moderate to severe PIHP due to acne (score PAHPI \> 10);
* Subjects with mild acne on the face (GEA = 2);
* ≤ 4 inflammatory lesions total (non-inflammatory lesions could be 0)
Exclusion Criteria:
* Subjects with symptoms of COVID-19 (moderate fever, dry cough and other symptoms described by the World Health Organization);
* Subjects with a temperature above 37.5 °C;
* COVID-19 positive patients;
* For women: pregnant or nursing woman or woman planning to get pregnant during the study;
* Cutaneous pathology on the study zone (eczema, etc);
* Use of topical or systemic treatment (for ex: treatment of acne) during the previous weeks liable to interfere with the assessment of the cutaneous acceptability/efficacy of the study product;
* Subject with make-up products on the day of the visit at the laboratory;
* Acne and depigmenting treatment (topical or systemic):
* Topical treatment claiming depigmenting effect of the face: within the last month,
* Facial procedures: within the last 3 months,
* Systemic retinoid: within the last 6 months.
* Cosmetic product for non-comedogenicity within the last 2 weeks;
* Subjects treated for PIHP within the past 3 months with either a cosmetic product or a drug;
* Any change in hormonal treatment (including contraceptive) during the three previous months of the study;
* Subject having undergone a surgery under general anesthesia within the previous month;
* Excessive exposure to sunlight or UV-rays within the previous month;
* Subject enrolled in another clinical trial during the study period.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT06770127
Study Brief:
Protocol Section:
NCT06770127