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

Study Overview
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Brief Summary
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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.

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

Conditions
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Solar Lentigines

Intervention / Treatment
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* Device: Q-switched SINON Ruby Laser
* Drug: Pigmanorm Cream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pigmanorm Cream, Q-switched Ruby laser,solar lentigines<br>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. | Device: Q-switched SINON Ruby Laser<br>* 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.<br>Drug: Pigmanorm Cream<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 140 days (Baseline, Day 28, Day 56, Day 140) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of safety profile | Adverse effects are noted at each visit. | 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). | Long term outcome is assessed 3 months after finishing treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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solar lentigines, Q-switches Laser, bleaching cream