No registrations found.
ID
Source
Brief title
Health condition
Excessive hair growth, hirsutism
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility of hair removal treatment with the Splendor-X SMART laser platform for hair removal treatment for all skin types.
Secondary outcome
• 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.
Background summary
It is a Prospective Multi Center Feasibility study, Within-Subject Controlled Treatment in healthy subjects. Subjects will receive 3 treatments and will return for two follow-up visits. Each treatment will include at least 2 different anatomical areas comparing each one in a left/right side to side comparison for 1) Splendor-X standard treatment: the investigator will choose his/her own laser presets to treat the subject with and 2) Splendor-X SMART treatment: the Splendor-X SMART system will calculate the recommended laser presets for optimal safety and efficacy parameters.
Study objective
We assume that hair removal treatment with the Splendor-X SMART is feasible.
Study design
Screening visit max 14 days before treatment 1, treatment 1, treatment 2 at 6 to 8 weeks after treatment 1, treatment 3 at 6 to 8 weeks after treatment 2, follow-up visit 1 at 3 months after treatment 3, follow-up visit 2 at 6 months after treatment 3.
Intervention
The study includes a total of up to 6 visits: 1 screening visit, 3 treatment visits and 2 follow-up visits.
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
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
Recruitment
IPD sharing statement
Plan description
The information and the key to the code will be stored at the clinical study site and may be transferred for the purpose of processing, analysis etc. to associated researchers outside the European Economic Area. This transfer will be done according to the European General Data Protection Regulation 2016. The data will be stored for 15 years at the hospital and for 15 years with the Sponsor. The key will not be shared with the Sponsor.
There are some people who will have access to personal information without the code. These people are monitors, Sponsor representative that may be present during procedures, and National and international authorities (for instance the Healthcare and Youth Inspectorate of the Netherlands). These people will keep the subject’s information confidential.
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9651 |
| Other | METC AMC : 2021_026 |