An interventional study of Q-switched SINON Ruby Laser and Pigmanorm Cream in Solar Lentigines, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-16.
Sponsored by University of Zurich · Not applicable, Interventional, and Treatment
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.
28 studies on the registry are indexed under Lentigo; 2 are open to participants now.
This study's enrollment of 15 is below the median of 30 across 25 interventional studies indexed under Lentigo.
Browse Lentigo studies →University of Zurich is the lead sponsor of 1,049 studies on the registry; 133 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Drug: Pigmanorm Cream
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.
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).
Time frame: 140 days (Baseline, Day 28, Day 56, Day 140)
Evaluation of safety profile
Adverse effects are noted at each visit.
Time frame: 140 days (Baseline, Day 28, Day 56, Day 140)
Change from Baseline in Pigmentation at day 140
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).
Time frame: Long term outcome is assessed 3 months after finishing treatment.
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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