Efficacy and Safety Evaluation of Splendor-X SMART System for hair removal
- Conditions
- Excessive hair growth, hirsutism
- Registration Number
- NL-OMON29490
- Lead Sponsor
- umenis Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 40
1.All skin types: I-VI
2.male or female
3.Age – 18-50 years of age
4.Having two suitable treatment areas (legs, thighs, back, Chest, axillae, bikini, front of the neck or abdomen) with dark brown or black hair appropriate for hair removal;
1.Previous hair removal procedures at intended areas
2.Active infections in the treated area;
3.Dysplastic nevi in the treatment area;
4.Significant concurrent skin conditions or any inflammatory skin conditions;
5.Active cold sores, open lacerations or abrasions in the treated area;
6.Chronic or cutaneous viral, fungal, or bacterial diseases;
7.Intense tan, Deep suntan, recent suntan within 2 weeks, sunburn or artificially tanned skin;
8.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 Feasibility of hair removal treatment with the Splendor-X SMART laser platform for hair removal treatment for all skin types.
- Secondary Outcome Measures
Name Time Method •Percent change of number of hairs before and after 3 treatments with the Splendor-X SMART system as compared to Splendor-X.<br>•Difference between the Splendor-X SMART system and the subjective physician judgment on standard assessments of skin characteristics.<br>•Splendor-X SMART melanin and erythema measurements as compared to MX18 for each treatment.<br>