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 range35 Years – 65 Years

SexALL

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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.
✕. Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles per investigator's discretion.
✕. Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases per investigator's discretion.
✕. Pregnancy or nursing, as well as 3-6 months post-childbirth.
✕. History of bleeding coagulopathies, or prolonged use of anticoagulants (daily aspirin dosing of 81 mg is acceptable).
✕. Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medication per investigator's discretion.
✕. Subjects with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regime.

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

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