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The objective of the study is to evaluate the safety, efficacy and usage compliance of the home-use device Silk'n HST for self-treatment of periorbital wrinkles and skin laxity and improvement of skin appearance.
This is a single arm prospective study of 18 weeks aimed to evaluate the safety and efficiency of Silk'n HST treatment on the periorbital areas. 30 subjects will be enrolled by a single USA clinical site. Throughout the trial there will be 3 pre-scheduled face to face treatment visits, as well as additional 18 independent treatments at home. 2 additional follow-up visits will be conducted 1 and 3 months following treatment end. In addition, 2 maintenance treatment will be conducted independently at home once a month following treatment end.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Each subject will serve as his/her own control, while comparing results before treatment, and after 6 weeks of treatment. Intervention includes treatment with the Silk'n HST on the periorbital areas as instructed in the user's manual. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silk'n HST | Device | Treatment with Silk'n HST on the periorbital area as instructed in the user's manual |
|
| Measure | Description | Time Frame |
|---|---|---|
| reduction of wrinkle severity according to the Fitzpatrick wrinkle scale | measurements were accomplished via standardized photographs blinded evaluation. | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| subjective wrinkle improvement as measured by satisfactory questionnaires | A subjective impression of improvement in wrinkle appearance following 6 weeks treatment, 3 months following treatment end. | 18 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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