Back to resultsComparative Study of the Therapy of Solar Lentigines With a Q-switched Rubin Laser Versus a Bleaching Cream
Primary Purpose
Solar Lentigines
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Q-switched SINON Ruby Laser
Pigmanorm Cream
Sponsored by
About this trial
This is an interventional treatment trial for Solar Lentigines focused on measuring solar lentigines, Q-switches Laser, bleaching cream
Eligibility Criteria
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
Sites / Locations
- University Hospital Zurich, Division of Dermatology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pigmanorm Cream, Q-switched Ruby laser,solar lentigines
Arm Description
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Evaluation of safety profile
Adverse effects are noted at each visit.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02153697
Brief Title
Comparative Study of the Therapy of Solar Lentigines With a Q-switched Rubin Laser Versus a Bleaching Cream
Official Title
Comparative Study Investigating the Therapy of of Solar Lentigines With the Q-switched SINON Rubin 694nm Laser Versus Pigmanorm® Cream
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solar Lentigines
Keywords
solar lentigines, Q-switches Laser, bleaching cream
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pigmanorm Cream, Q-switched Ruby laser,solar lentigines
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Q-switched SINON Ruby Laser
Intervention Description
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
Drug
Intervention Name(s)
Pigmanorm Cream
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of clearing of pigmentation
Description
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)
Secondary Outcome Measure Information:
Title
Evaluation of safety profile
Description
Adverse effects are noted at each visit.
Time Frame
140 days (Baseline, Day 28, Day 56, Day 140)
Title
Change from Baseline in Pigmentation at day 140
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospital Zurich, Division of Dermatology
City
Zurich
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Comparative Study of the Therapy of Solar Lentigines With a Q-switched Rubin Laser Versus a Bleaching Cream
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