A clinical trial to study the safety and efficacy of the LightSheer Duet 1060nm HS laser system
Not Applicable
- Registration Number
- CTRI/2014/01/004292
- Lead Sponsor
- umenis India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
Healthy adult, females or males (at least 80% female) older than 18 years of age with skin type I-VI; Having at least two suitable treatment areas for hair removal with dark brown or black hair;
Exclusion Criteria
•Active infections;
•Dysplastic nevi;
•Tattoos;
•Significant concurrent skin conditions or any inflammatory skin conditions;
•Active cold sores, open lacerations or abrasions;
•Chronic or cutaneous viral, fungal, or bacterial diseases;
•Deep suntan, recent suntan, sunburn or artificially tanned skin;
•Current skin cancer
•Treatment should not be attempted on patients with a history of skin cancer or pre-cancerous lesions at the treatment areas;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy <br/ ><br>Demonstrate temporary hair removal 4-6 weeks following 3 treatments. <br/ ><br>Safety <br/ ><br>To evaluate the safety of hair removal using the LightSheer Duet 1060nm in Fitzpatrick I-VI and tanned skin types. <br/ ><br>Timepoint: Post Treatment 3
- Secondary Outcome Measures
Name Time Method â?¢Demonstrate temporary hair removal 3 month following 5 treatments. <br/ ><br>â?¢Demonstrate permanent hair reduction 6 months following 5 treatments. <br/ ><br>â?¢Evaluate the immediate response following treatment as well as the subjectâ??s perception of the treatment. <br/ ><br>â?¢Evaluate hair coarseness and color. <br/ ><br>â?¢Evaluate length of the treatment. <br/ ><br>â?¢Evaluate the tissue alterations at the follicular level.Timepoint: 3 and 6 months post Treatment 5