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:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT06822335
Eligibility Criteria:
Inclusion Criteria:
* Female and male subjects aged between 18 - 50 years old.
* Subject of Fitzpatrick phototype III-VI.
* Subject must be willing and be able to comply with the study schedule, procedures, and restrictions.
* Subjects with moderate to severe scores (4-8) on mean darkness intensity.
* Subjects with moderate to severe PIHP due to acne (score PAPHI\>10).
* Subjects with mild acne (GEA 2),
* Subjects having ≤ 4 inflammatory lesions total,
* Subjects showing understanding of the study procedures, restrictions, willingness to participate as evidenced by voluntary written informed consent.
Exclusion criteria
* Pregnant or intending to become pregnant during the study or breastfeeding or in menopause.
* Subjects under any hormonal therapy, such as contraceptive pills or androgen agonist/antagonist medications, within the last 3 months before Visit 1 or planning to start any therapy during the study.
* Subject with 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).
* Moderate to severe acne (GEA \>2).
* Systemic treatment of retinoids during the six previous months of the study.
* Under retinoid treatment within the last 6 months, including Over. The Counter (OTC) and all derivates of retinoids (e.g., retinol, retinal, retinaldehyde, retinol esters, etc.).
* Under any acne medication (including oral medication/laser treatment) within the last 6 months.
* Subjects treated for PIHP within the past 3 months with either a cosmetic product or a drug.
* Subject with make-up products on the day of the visit at the center.
* Cosmetic product for non-comedogenicity within the last 2 weeks.
* History of skin cancer.
* History of abnormal response to sun.
* Presence of recent suntan (according to Investigator opinion) or photo-test marks.
* History of allergy, hypersensitivity, or any serious reaction to any cosmetic product.
* Any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator.
* Having used within the month before inclusion any systemic medication for more than 5 consecutive days (e.g., steroidal, and non-steroidal anti-inflammatory drugs, corticoids, insulin, antihistamines, antihypertensive, antibiotics -e.g., quinolone, tetracycline, thiazides, fluoroquinolones-).
* Any subject who, in the judgment of the Investigator, should not participate in the study.
* Subject who cannot be contacted by telephone in case of emergency.
* Subject having participated within the 14 days before inclusion or currently participating in another clinical study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT06822335
Study Brief:
Protocol Section:
NCT06822335