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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: Cutera Inc.

Current Primary Outcome: Investigator Assessment measured by 5-point improvement scale [ Time Frame: 12 weeks ]

Degree of improvement in melasma or lentigines at 3 months post-final treatment measured by 5-point improvement scale.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Subject Assessment measured by 5-point improvement scale [ Time Frame: 12 weeks ]
    Degree of improvement in melasma or lentigines at 3 months post-final treatment measured by 5-point improvement scale.
  • Melasma Subject's MASI Improvement [ Time Frame: 12 weeks ]
    Change in mean Melasma Area and Severity Index (MASI) value at 3 months post-final treatment as compared to baseline
  • Relative Melanin Index [ Time Frame: 12 weeks ]
    Change in mean relative Melanin Index (MI) value at 3 months post-final treatment as compared to baseline as assessed by mexameter measurements
  • Pain and Adverse Events [ Time Frame: Day 1 ]
    Incidence and severity of adverse device effects during the study period, including subject pain level during laser treatment


Original Secondary Outcome:

  • Subject Assessment measured by 5-point improvement scale [ Time Frame: 12 weeks ]
    Degree of improvement in melasma or lentigines at 3 months post-final treatment measured by 5-point improvement scale.
  • Subject Assessment measured by 5-point improvement scale [ Time Frame: 12 weeks ]
    Degree of satisfaction in melasma or lentigines at 3 months post-final treatment measured by 5-point improvement scale.
  • Melasma Subject's MASI Improvement [ Time Frame: 12 weeks ]
    Change in mean Melasma Area and Severity Index (MASI) value at 3 months post-final treatment as compared to baseline
  • Relative Melanin Index [ Time Frame: 12 weeks ]
    Change in mean relative Melanin Index (MI) value at 3 months post-final treatment as compared to baseline as assessed by mexameter measurements
  • Pain and Adverse Events [ Time Frame: Day 1 ]
    Incidence and severity of adverse device effects during the study period, including subject pain level during laser treatment


Information By: Cutera Inc.

Dates:
Date Received: March 3, 2015
Date Started: April 2015
Date Completion:
Last Updated: January 30, 2017
Last Verified: January 2017