Treatment and Prevention of Melasma Relapses by Using 1064nm 650 Microsecond Laser

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NICE · Oct 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat and prevent melasma, a common skin condition that causes dark patches on the face, often affecting women, especially during or after pregnancy. The researchers believe that using a special laser treatment, along with a cream that helps lighten the skin, could improve results and reduce the chances of the melasma coming back. Participants will apply a depigmenting cream twice a day for three months and receive six laser treatment sessions on one side of their face over 12 weeks. They will also use a high-SPF sunscreen throughout the study.

To be eligible, participants need to be at least 18 years old and have moderate to severe melasma. Women who can become pregnant must use effective contraception and have a negative pregnancy test before joining. It's important that participants can attend all study visits and sign an informed consent form. However, pregnant or breastfeeding women, those with other skin conditions, or recent users of certain skin treatments cannot participate. If you or someone you know is struggling with melasma and meets these criteria, this study may be a good opportunity to explore new treatment options.

Gender

ALL

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.