NCT02913547

Silk'n HST for Wrinkle Reduction - Clinical Study Protocol

Safety, Efficacy and Usage Compliance of the Silk'n HST Home Use Device for Treating Periorbital Wrinkles and Improving Skin Appearance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Home Skinovations Ltd. · Industry
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Wrinkles

Interventions

Type	Name	Description
DEVICE	Silk'n HST	Treatment with Silk'n HST on the periorbital area as instructed in the user's manual

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-05-01
• Completion: 2016-06-01
• First posted: 2016-09-23
• Last updated: 2018-08-07