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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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
measurements were accomplished via standardized photographs blinded evaluation.
Time frame: 18 weeks
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.
Time frame: 18 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.