Comparative Study Investigating the Therapy of of Solar Lentigines With the Q-switched SINON Rubin 694nm Laser Versus Pigmanorm® Cream
Sponsor study identifier
interventional
15
1 country
1
Study Start
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2014
Actual (reported)Study Completion
October 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
May 20, 2014
Actual (reported)June 3, 2014
Actual (reported)October 2014
Actual (reported)October 2014
Actual (reported)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)
Evaluation of safety profile
140 days (Baseline, Day 28, Day 56, Day 140)
Change from Baseline in Pigmentation at day 140
Long term outcome is assessed 3 months after finishing treatment.
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.
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.
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.
University Hospital Zurich, Division of Dermatology
Zurich, Switzerland
15 participants (actual enrollment reported by the registry).
First Submitted
May 20, 2014
First Posted
June 3, 2014
Study Start
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
Side Effects of Q-Switched Ruby Laser for the Treatment of Lentigines in Light and Dark Skin Types
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Primary Completion
October 2014
Actual (reported)Study Completion
October 2014
Actual (reported)Last Updated
December 16, 2014
Record last verified: 2014-12
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Source: ClinicalTrials.gov.
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