Clinical Trial: Study of the 532 nm KTP Laser for the Treatment of Poikiloderma of Civatte

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

Official Title: A Single-Center Prospective, Open-Label Study of the Excel V 532 nm KTP Laser for the Treatment of Poikiloderma of Civatte

Brief Summary: This study will evaluate the safety and efficacy of the Excel V 532 nm KTP laser for the treatment of dyschromia of the neck and/or chest (poikiloderma of Civatte).

Detailed Summary:
Sponsor: Cutera Inc.

Current Primary Outcome:

• Severity Assessment Score [ Time Frame: 24 weeks post final treatment ]
  Change in physician's Severity Assessment score based on blinded assessment of subject photographs by a panel of independent dermatologists.
• Physician's Global Assessment (Blinded) [ Time Frame: 24 weeks post final treatment ]
  Before and after subject photographs will be presented to a panel of independent dermatologists. The panel will be blinded to treatment parameters and the photograph time point. Each dermatologist will be asked to select the baseline photograph and then rate improvement in poikiloderma of Civatte in the post-treatment photograph using a 5-point improvement scale.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Physician's Global Assessment [ Time Frame: 12 and 24 weeks post final treatment ]
  Investigator will assess improvement in poikiloderma of Civatte as compared to baseline using a 5-point improvement scale.
• Severity Assessment Score [ Time Frame: 12 and 24 weeks post final treatment ]
  Investigator will perform Severity Assessment of the subject's poikiloderma of Civatte.
• Subject's Global Assessment [ Time Frame: 12 and 24 weeks post final treatment ]
  Subjects will assess improvement of poikiloderma of Civatte as compared to baseline using a 5-point improvement scale.
• Subject Satisfaction Assessment [ Time Frame: 12 and 24 weeks post final laser treatment ]
  Subjects will assess overall satisfacion with improvement of poikiloderma of Civatte and proceedure using a 5-point satisfaction scale.
• Spectrophotometer Measurement [ Time Frame: 12 and 24 weeks post final laser treatment ]
  Change in pigmentation and erythema as assessed by spectrophotometer measurements as compared to baseline.
• Assessment of Adverse Events [ Time Frame: 24 weeks post final laster treatment ]
  Incidence and severity of all procedure-related adverse events.

Original Secondary Outcome: Same as current

Information By: Cutera Inc.

Dates:
Date Received: December 5, 2011
Date Started: November 2011
Date Completion:
Last Updated: August 5, 2013
Last Verified: August 2013