Using a laser treatment to prevent melasma relapses

Treatment and Prevention of Melasma Relapses by Using 1064nm 650 Microsecond Laser: a Prospective Randomized Intra-individual Study

This study is testing if a combination of laser treatment and a special cream can help people with moderate to severe melasma keep it from coming back.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Nice (other)
• Locations: 1 site (Nice, Alpes-Maritimes)
• Trial ID: NCT06644157 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of the Aerolase laser treatment in conjunction with a topical depigmenting agent, Mela B3 cream, for patients with moderate to severe melasma. Participants will apply the cream twice daily for three months while receiving laser treatment on one side of their face every other week for a total of six sessions. The aim is to enhance the efficacy of the cream and reduce the intensity of melasma relapses by targeting both pigmentation and vascular components. The study will also include the use of a high SPF sunscreen to protect the skin during treatment.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 18 and older with clinically diagnosed moderate to severe melasma.

Not a fit: Patients with mild melasma or those who do not meet the inclusion criteria, such as those not using effective contraception if they are women of childbearing potential, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the frequency and severity of melasma relapses in affected patients.

How similar studies have performed: While there is limited data on this specific laser treatment for melasma, similar laser therapies have shown promise in managing hyperpigmentation disorders.

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.

Where this trial is running

Nice, Alpes-Maritimes

• CHU de Nice - Hôpital de l'Archet — Nice, Alpes-Maritimes, France (RECRUITING)

Study contacts

• Principal investigator: Thierry Passeron, PhD — CHU de Nice, Service de Dermatologie
• Study coordinator: Thierry Passeron, ¨PhD

Conditions: Melasma