NCT06644157

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melasma

Interventions

Type	Name	Description
DEVICE	Laser Néo Élite	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.

Timeline

• Start date: 2024-12-10
• Primary completion: 2026-03-01
• Completion: 2026-09-01
• First posted: 2024-10-16
• Last updated: 2025-12-01

Locations

1 site across 1 country: France