Silk'n HST for Wrinkle Reduction - Clinical Study Protocol
|ClinicalTrials.gov Identifier: NCT02913547|
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : August 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Wrinkles||Device: Silk'n HST||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety, Efficacy and Usage Compliance of the Silk'n HST Home Use Device for Treating Periorbital Wrinkles and Improving Skin Appearance|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||June 2016|
Experimental: Treatment group
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.
Device: Silk'n HST
Treatment with Silk'n HST on the periorbital area as instructed in the user's manual
- reduction of wrinkle severity according to the Fitzpatrick wrinkle scale [ Time Frame: 18 weeks ]measurements were accomplished via standardized photographs blinded evaluation.
- subjective wrinkle improvement as measured by satisfactory questionnaires [ Time Frame: 18 weeks ]A subjective impression of improvement in wrinkle appearance following 6 weeks treatment, 3 months following treatment end.