We assume that hair removal treatment with the Splendor-X SMART is feasible.
ID
Bron
Verkorte titel
Aandoening
Excessive hair growth, hirsutism
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Feasibility of hair removal treatment with the Splendor-X SMART laser platform for hair removal treatment for all skin types.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
We assume that hair removal treatment with the Splendor-X SMART is feasible.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
The study includes a total of up to 6 visits: 1 screening visit, 3 treatment visits and 2 follow-up visits.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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;
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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;
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
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.
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9651 |
| Ander register | METC AMC : 2021_026 |