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

Study acronym: Melasma650
StatusActive, Not Recruiting
PhaseNot applicable
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Primary completion date changed from estimate of Mar 1, 2026 to Jul 7, 2026
    • Study completion pushed from Sep 1, 2026 to Feb 1, 2027
    • Eligibility criteria expanded, about 27 words
    • Site details revised
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v5
  3. Minor Start date changed from estimate of Dec 1, 2024 to Dec 10, 2024v4
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  5. Notable Primary endpoint revised
    • Secondary endpoints: details revised at 1 of 1 entry
    v2
  6. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06644157
Lead Sponsor Centre Hospitalier Universitaire de Nice
Conditions
(from sponsor)
Melasma
Related terms Melanosis
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov