Overmatige haargroei Excessive hair growth hirsutism
Conditions
Interventions
Within-subject randomization will assign standard treatment or Splendor X SMART
AI guided treatment to either left or right half of the anatomical area.
Sponsors
Lumenis Be Ltd.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Parameters Feasibility studies are usually not powered as the number of participants is not critical - but obviously: the more, the better. Power calculations for demonstrating efficacy are below. Outcomes: Primary Endpoint Feasibility of hair removal treatment with the Splendor-X SMART system for all skin types. Treatment with the Splendor-X SMART system will be consider as feasible when a full treatment is completed using the calculated recommended laser presets by the AI system (preset is not overruled by the physician). The percentage of success will be documented. Safety endpoints - Incidence of adverse events during the treatment and follow-up period - Immediate response (erythema, edema, purpura, etc.) following each treatment measured on a 5-point Likert severity scale. - Subject*s assessment of pain and discomfort associated with treatments using an 11-point VAS pain score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints - Percent change of number of hairs before and after 3 treatments with the Splendor-X SMART guided as compared to the Splendor-X. - Difference between the measurements from novel Splendor-X SMART system and the subjective physician judgment on standard assessments of skin characteristics (hair color, thickness, density). - Splendor-X SMART melanin and erythema measurements as compared to MX18 for each treatment. | — |
Countries
Netherlands
Outcome results
None listed