Treatment and Prevention of Melasma Relapses by Using 1064nm 650 Microsecond Laser (NCT06644157) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Treatment and Prevention of Melasma Relapses by Using 1064nm 650 Microsecond Laser
France30 participantsStarted 2024-12-10
Plain-language summary
Melasma is a frequently acquired hyperpigmentary disorder affecting up to 30% of child-bearing women in some populations. Melasma is still often called chloasma or the pregnancy mask and is considered as the main consequence of female hormone stimulation on a predisposed genetic background but only 20% of pregnant women are affected. The investigator hypothesize that the Aerolase laser treatment could not only enhance the efficacy of the topical depigmenting agents but also by reducing the vascular component decrease the intensity of the relapses.
All patients applied to the entire face the cosmetic depigmenting agent Mela B3 (La Roche Posay) cream twice daily for 3 months. One session of laser on one side of the face (randomly assigned for each patient for the duration of the study) will be performed every other week for 12 weeks for a total of 6 sessions. All the patients will apply the entire face a sunscreen of sun protection factor 50 with high UVA protection (UV Mune 400; La Roche Posay) during the entire study duration.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Men and women with a clinically diagnosed moderate to severe melasma (mMASI above 5)
✓. ≥ 18 years old
✓. 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.
✓. Affiliation to a social security system
✓. Signed informed consent
✓. Patient willing and able to attend all study visits
Exclusion criteria
✕. Pregnant or breast-feeding women or women with potential childbearing and not taking contraceptives or who plan to get pregnant during the study duration.
✕. Patient with additional facial pigmentary disorder.
✕. 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.
✕. Patient having other facial dermatosis that may interfere with the evaluation of the treatment
✕. Patient having used a local corticosteroid on the skin, eyes, nose or mouth (inhaled corticosteroid) or systemic corticosteroids during the month preceding inclusion.
✕. Patients with a contraindication to laser treatment are :
✕. Patient having used local tretinoin or local hydroquinone during the month preceding inclusion.
✕. Patient undergoing chronic anti-inflammatory treatment (NSAID use accepted if less than 10 days cumulative over the entire study).