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 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT06644157
Eligibility Criteria:
Inclusion Criteria:
1. Men and women with a clinically diagnosed moderate to severe melasma (mMASI above 5)
2. ≥ 18 years old
3. For Women of childbearing potential (WOCBP), an effective contraception (estroprogestative pill, contraceptive implant, IUD, condoms or tubal ligation) should be used for more than one month before the inclusion in the study.
Women of childbearing potential (WOCBP) must have a negative urine pregnancy test result at baseline.
WOCBP are defined as women who are biologically capable of becoming pregnant, including women who are using contraceptives or whose sexual partners are either sterile or using contraceptives.
Women of non-childbearing potential (WONCBP) do not require a urine pregnancy test and must meet at least one of the following criteria:
* Have undergone hysterectomy or bilateral oophorectomy.
* Have medically confirmed ovarian failure; or
* Are medically confirmed to be post-menopausal (cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause).
4. Affiliation to a social security system
5. Signed informed consent
6. Patient willing and able to attend all study visits
Exclusion Criteria:
1. Pregnant or breast-feeding women or women with potential childbearing and not taking contraceptives or who plan to get pregnant during the study duration.
2. Patient with additional facial pigmentary disorder.
3. Patient having used a depigmenting cosmetic in the month prior to inclusion or having used a local corticosteroid on the skin, eyes, nose or mouth (inhaled corticosteroid) or systemic corticosteroids in the month prior to inclusion or having used local tretinoin or local hydroquinone in the month prior to inclusion.
4. Patient having other facial dermatosis that may interfere with the evaluation of the treatment
5. Patient having used a local corticosteroid on the skin, eyes, nose or mouth (inhaled corticosteroid) or systemic corticosteroids during the month preceding inclusion.
6. Patients with a contraindication to laser treatment are :
* A history of keloids or other abnormal scars.
* Use of photosensitising medication or history of photosensitivity disorders - Lupus erythematosus
* Sunburn in the treatment area
* Active infection in the treatment area
7. Patient having used local tretinoin or local hydroquinone during the month preceding inclusion.
8. Patient undergoing chronic anti-inflammatory treatment (NSAID use accepted if less than 10 days cumulative over the entire study).
9. Patient with a history of clinically significant allergy, in particular to components of the products studied.
10. Adult under guardianship or deprived of freedom
11. Patient in a situation, which, in the opinion of the Investigator, may interfere with optimal participation in the study.
12. Participants in other clinical therapeutic studies involving a drug that could interfere with the present evaluation.
13. Patient unable to communicate effectively with Investigator or unable to follow study requirements
14. Patient refusing to be photographed within the study period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06644157
Study Brief:
Protocol Section:
NCT06644157