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Silk'n HST for Wrinkle Reduction - Clinical Study Protocol

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ClinicalTrials.gov Identifier: NCT02913547
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Home Skinovations Ltd.

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.

Condition or disease Intervention/treatment Phase
Wrinkles Device: Silk'n HST Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety, Efficacy and Usage Compliance of the Silk'n HST Home Use Device for Treating Periorbital Wrinkles and Improving Skin Appearance
Study Start Date : November 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: Treatment group

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




Primary Outcome Measures :
  1. reduction of wrinkle severity according to the Fitzpatrick wrinkle scale [ Time Frame: 18 weeks ]
    measurements were accomplished via standardized photographs blinded evaluation.


Secondary Outcome Measures :
  1. subjective wrinkle improvement as measured by satisfactory questionnaires [ Time Frame: 18 weeks ]
    A subjective impression of improvement in wrinkle appearance following 6 weeks treatment, 3 months following treatment end.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Adult subjects aged 35-65.
  2. 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).
  3. 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.
  4. The subjects will carry on with their usual diet and exercise and will not have a significant weight change during the study.
  5. The subject is able to read the User Manual in English.
  6. Subjects should have II-VI Fitzpatrick wrinkle score as indicated on the Fitzpatrick Wrinkle and Elastosis Scale (see Table 1).
  7. Negative results in a urine pregnancy test.

Exclusion Criteria:

  1. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
  2. Permanent implant in the treated area such as metal plates and screws, silicone implants or an injected chemical substance.
  3. Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles per investigator's discretion.
  4. Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases per investigator's discretion.
  5. Pregnancy or nursing, as well as 3-6 months post-childbirth.
  6. History of bleeding coagulopathies, or prolonged use of anticoagulants (daily aspirin dosing of 81 mg is acceptable).
  7. Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medication per investigator's discretion.
  8. 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.
  9. Poorly controlled endocrine disorders, such as diabetes or thyroid abnormality per investigator's discretion.
  10. Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash per investigator's discretion.
  11. History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin per investigator's discretion.
  12. Any surgery in treated area within 3 months prior to treatment or before complete healing.
  13. Injected fillers in the last 6 months and Botox in the last week.
  14. Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
  15. As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the subject.
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Responsible Party: Home Skinovations Ltd.
ClinicalTrials.gov Identifier: NCT02913547    
Other Study ID Numbers: DO109828
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided