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

NCT ID: NCT02153697

Last Updated: 2014-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-10-31

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.

Detailed Description

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Conditions

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Solar Lentigines

Keywords

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solar lentigines Q-switches Laser bleaching cream

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Q-switched SINON Ruby Laser

Intervention Type DEVICE

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.

Pigmanorm Cream

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DRUG

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Zurich, Division of Dermatology

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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KEK-ZH-Nr. 2013-0435

Identifier Type: -

Identifier Source: org_study_id