NCT02385994

A Prospective Multi-Center Study Using Laser for the Treatment of Melasma and Lentigines in Asian Skin

A Prospective Multi-Center Study of a Novel Dual-Wavelength, Dual-Pulse Duration Laser for the Treatment of Melasma and Lentigines in Asian Skin

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Cutera Inc. · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this investigation is to evaluate safety and efficacy of the Cutera enlighten dual-pulse duration, dual-wavelength 532nm KTP/1064nm Nd:YAG laser for the treatment of melasma and lentigines on the face in Asian skin.

Detailed description

This is a multi-center prospective, 2 cohort study in 80 male or female subjects of Asian-descent, who desire laser treatment for moderate to severe melasma (all types) or lentigines (all types) located on the face. Forty subjects will be enrolled in cohort 1 and randomized to either treatment or control arm. Forty subjects will be enrolled for treatment of facial lentigines in cohort 2.

Conditions

• Melasma
• Lentigines

Interventions

Type	Name	Description
DEVICE	enLighten Laser	enLighten Laser treatment with dual-pulse width and dual-wavelength

Timeline

• Start date: 2015-04-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2015-03-11
• Last updated: 2017-01-31

Locations

2 sites across 2 countries: China, Japan