Excessive hair growth, hirsutism
Conditions
Interventions
The study includes a total of up to 6 visits: 1 screening visit, 3 treatment visits and 2 follow-up visits.
Sponsors
Lumenis Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 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;
Exclusion criteria
Exclusion criteria: 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of hair removal treatment with the Splendor-X SMART laser platform for hair removal treatment for all skin types. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Percent change of number of hairs before and after 3 treatments with the Splendor-X SMART system as compared to Splendor-X. • Difference between the Splendor-X SMART system and the subjective physician judgment on standard assessments of skin characteristics. • Splendor-X SMART melanin and erythema measurements as compared to MX18 for each treatment. | — |
Contacts
Public ContactAlbert Wolkerstorfer
Amsterdam UMC
Outcome results
None listed