Clinical Trial: Comparative Study of the Therapy of Solar Lentigines With a Q-switched Rubin Laser Versus a Bleaching Cream

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

Official Title: Comparative Study Investigating the Therapy of of Solar Lentigines With the Q-switched SINON Rubin 694nm Laser Versus Pigmanorm® Cream

Brief Summary:

Benign pigmented lesions as solar lentigines are a common finding in Caucasian individuals. Their removal may be requested for aesthetic reasons.

The goal of the study is comparing the efficacy and tolerance of two different therapy modalities established for treating solar lentigines.

The right back of the hand side will be treated with the Q-switched SINON Rubin 694nm Laser, the left back of the hand side with a hydrochinon containing bleaching cream (Pigmanorm® cream).

The investigators estimate that a physical therapy with a Q-switched Rubin laser system is more effective in the removal of solar lentigines than a topical chemical therapy with a hydrochinon containing bleaching cream.


Detailed Summary:
Sponsor: University of Zurich

Current Primary Outcome: Evaluation of clearing of pigmentation [ Time Frame: 140 days (Baseline, Day 28, Day 56, Day 140) ]

The primary efficacy objective is to evaluate the clearing of pigmentation(percentage of clearing) following a quartile scale of poor (25% clearance), fair (26-50% clearance), good (51-75% clearance), and excellent (76-100% clearance).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Evaluation of safety profile [ Time Frame: 140 days (Baseline, Day 28, Day 56, Day 140) ]
    Adverse effects are noted at each visit.
  • Change from Baseline in Pigmentation at day 140 [ Time Frame: Long term outcome is assessed 3 months after finishing treatment. ]
    The clearing of pigmentation (percentage of clearing) following a quartile scale of poor (25% clearance), fair (26-50% clearance), good (51-75% clearance), and excellent (76-100% clearance) is assessed at day 140 from Baseline ( = 3 months after finishing treatment).


Original Secondary Outcome: Same as current

Information By: University of Zurich

Dates:
Date Received: May 20, 2014
Date Started: March 2014
Date Completion:
Last Updated: December 15, 2014
Last Verified: December 2014