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

University of Zurich15 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solar Lentigines

Interventions

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Evaluation of clearing of pigmentation

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).

Time frame: 140 days (Baseline, Day 28, Day 56, Day 140)

Secondary Outcomes

Evaluation of safety profile

Adverse effects are noted at each visit.

Time frame: 140 days (Baseline, Day 28, Day 56, Day 140)

Change from Baseline in Pigmentation at day 140

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).

Time frame: Long term outcome is assessed 3 months after finishing treatment.