CompletedNot Applicable

Silk'n HST for Wrinkle Reduction - Clinical Study Protocol

30 participantsStarted 2015-11

Plain-language 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.

Who can participate

Age range

35 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Adult subjects aged 35-65.
. The subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects, and sign the Informed Consent Form, including the permission to use photography (forms attached).
. The subjects should be willing to comply with the study procedure and schedule, including the follow up visits, and will refrain from using any other or similar treatment technologies (i.e., Laser, RF, IR) for the facial condition.
. The subjects will carry on with their usual diet and exercise and will not have a significant weight change during the study.
. The subject is able to read the User Manual in English.
. Subjects should have II-VI Fitzpatrick wrinkle score as indicated on the Fitzpatrick Wrinkle and Elastosis Scale (see Table 1).
. Negative results in a urine pregnancy test.

Exclusion criteria

. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
. Permanent implant in the treated area such as metal plates and screws, silicone implants or an injected chemical substance.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

reduction of wrinkle severity according to the Fitzpatrick wrinkle scale

Timeframe: 18 weeks

Trial details

NCT IDNCT02913547

SponsorHome Skinovations Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-05

View on ClinicalTrials.gov More Wrinkles trials