Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pigmanorm Cream, Q-switched Ruby laser,solar lentigines | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Q-switched SINON Ruby Laser | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of safety profile | Adverse effects are noted at each visit. | 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich, Division of Dermatology | Zurich | Switzerland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pigmanorm Cream | 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. |
|
| Long term outcome is assessed 3 months after finishing treatment. |