Efficacy and Safety Evaluation of Splendor-X SMART System for hair removal, Prospective Multi Center Feasibility study, Within-Subject Controlled Treatment in healthy subjects.
- Conditions
- Overmatige haargroeiExcessive hair growthhirsutism
- Registration Number
- NL-OMON52239
- Lead Sponsor
- umenis Be Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 20
Healthy adult, females or males, between 18 and 50 years of age with skin type
I-VI, having at least moderately dense dark brown or black hair on at least 2
areas. These treated areas will diverse between anatomical areas: legs, thighs,
upper or lower back, chest or abdomen, axillae, bikini, front of the neck.
Previous hair removal procedures at intended areas
Active infections in the treated area;
Dysplastic nevi in the treatment area;
Significant concurrent skin conditions or any inflammatory skin conditions;
Active cold sores, open lacerations or abrasions in the treated area;
Chronic or cutaneous viral, fungal, or bacterial diseases;
Intense tan, Deep suntan, recent suntan within 2 weeks, sunburn or artificially
tanned skin;
Current cancer, 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
- Secondary Outcome Measures
Name Time Method