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

University of Zurich (UZH)

Status: Completed

Conditions: Solar Lentigines

Treatments: Drug: Pigmanorm Cream; Device: Q-switched SINON Ruby Laser

Study type: Interventional

Funder types: Other

Identifiers

NCT02153697

KEK-ZH-Nr. 2013-0435

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Pigmanorm Cream, Q-switched Ruby laser,solar lentigines

Experimental group

Description:

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.

Treatment:

Drug: Pigmanorm Cream

Device: Q-switched SINON Ruby Laser