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

Not Applicable

Completed

• Conditions: Solar Lentigines
• Interventions: Device: Q-switched SINON Ruby Laser; Drug: Pigmanorm Cream

• Registration Number: NCT02153697
• Lead Sponsor: University of Zurich

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 Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-05-20
• Study First Submitted QC: 2014-05-30
• Study First Posted: 2014-06-03
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-15
• Last Update Posted: 2014-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pigmanorm Cream, Q-switched Ruby laser,solar lentigines	Q-switched SINON Ruby Laser	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.
Pigmanorm Cream, Q-switched Ruby laser,solar lentigines	Pigmanorm Cream	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.

Primary Outcome Measures

Name	Time	Method
Evaluation of clearing of pigmentation	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 Outcome Measures

Name	Time	Method
Evaluation of safety profile	140 days (Baseline, Day 28, Day 56, Day 140)	Adverse effects are noted at each visit.
Change from Baseline in Pigmentation at day 140	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).

Trial Locations

Locations (1)

University Hospital Zurich, Division of Dermatology; 🇨🇭 Zurich, Switzerland