Silk'n HST for Wrinkle Reduction - Clinical Study Protocol

NCT02913547 | Completed

• 1 other identifier: DO109828
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Wrinkles

Outcome Measures

Primary Outcomes (1)

• reduction of wrinkle severity according to the Fitzpatrick wrinkle scale

  measurements were accomplished via standardized photographs blinded evaluation.

  18 weeks

Secondary Outcomes (1)

• subjective wrinkle improvement as measured by satisfactory questionnaires

  18 weeks

Study Arms (1)

Treatment group

EXPERIMENTAL

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

Interventions

Silk'n HST DEVICE

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

Treatment group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Poorly controlled endocrine disorders, such as diabetes or thyroid abnormality per investigator's discretion.
• Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash per investigator's discretion.
• History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin per investigator's discretion.
• Any surgery in treated area within 3 months prior to treatment or before complete healing.
• Injected fillers in the last 6 months and Botox in the last week.
• Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
• As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the subject.

Sponsors & Collaborators

• Home Skinovations Ltd.: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2016
• First Posted: September 23, 2016
• Study Start: November 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 7, 2018

Record last verified: 2016-09