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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2014

Interventions

  • Device: Q-switched SINON Ruby Laser
    • Solar lentigines on the right back of the hand side are treated with the Q-switched SINON Ruby Laser at Baseline and if required at day 28.
  • Drug: Pigmanorm Cream
    • Solar lentigines on the left back of the hand side are treated once a day during 7 weeks with Pigmanorm cream, a bleaching cream containing hydrochinon.

Arms, Groups and Cohorts

  • Experimental: Pigmanorm Cream, Q-switched Ruby laser,solar lentigines
    • Solar lentigines on the left back of the hand side are treated with Pigmanorm Cream once a day for 7 weeks. Solar lentigines on the right back of the hand side are treated with a Q-switched Ruby laser at Baseline and if required at day 28.

Clinical Trial Outcome Measures

Primary Measures

  • 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).

Secondary Measures

  • 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).

Participating in This Clinical Trial

Inclusion Criteria

  • Age ≥ 50 – female patient must be in post-menopause (> 2 years) – Clinically and dermoscopic confirmed solar lentigines on both sides back of the hands Exclusion Criteria:

  • non melanocytic pigmentation, vitiligo, melanoma and suspicion of melanoma – intolerance against an ingredience of pigmanorm® cream – acute inflammation or eczema on back of the hands – patients with renal disease – intake of photosensibilisating medication in the past 3 months – treatment of solar lentigines on back of the hands in the past 6 months – solarium or sun exposure about 6 weeks before and after treatment – immunsuppressed patients

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Zurich
  • Provider of Information About this Clinical Study
    • Sponsor

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