Comparative Study of the Therapy of Solar Lentigines With a Q-switched Rubin Laser Versus a Bleaching Cream
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02153697|
Recruitment Status : Completed
First Posted : June 3, 2014
Last Update Posted : December 16, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Solar Lentigines||Device: Q-switched SINON Ruby Laser Drug: Pigmanorm Cream||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparative Study Investigating the Therapy of of Solar Lentigines With the Q-switched SINON Rubin 694nm Laser Versus Pigmanorm® Cream|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
Experimental: 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.
Device: 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.
Drug: 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.
- Evaluation of clearing of pigmentation [ Time Frame: 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).
- Evaluation of safety profile [ Time Frame: 140 days (Baseline, Day 28, Day 56, Day 140) ]Adverse effects are noted at each visit.
- Change from Baseline in Pigmentation at day 140 [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153697
|University Hospital Zurich, Division of Dermatology|