Silk'n HST Device Usability and Self Selection Study

NCT02919007 | Completed Results

• 1 other identifier: DO111411
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Usability study, conducted for the purpose of testing Silk'n HST Device usability.

Conditions

Wrinkles

Outcome Measures

Primary Outcomes (1)

• Usability Assessment

  Study success is determined according to the ability of all subjects to complete device related tasks, including applying and operating the Device without assistance in a timeframe of up to 1 hour and with minimal attempts to ask for assistance.

  1 hour

Study Arms (1)

Silk'n HST treatment

EXPERIMENTAL

Intervention includes treatment with the Silk'n HST on the periorbital areas as instructed in the user's manual. Measure includes the ability to operate the device correctly according to the user manual.

Device: Silk'n HST treatment

Interventions

Silk'n HST treatment DEVICE

Intervention includes treatment with the Silk'n HST on the periorbital areas as instructed in the user's manual

Silk'n HST treatment

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is male or female equal to or greater than 18 years of age.
• Subject is a potential candidate for purchasing the Silk'n HST device.
• Subject has facility with both hands.
• Subject is capable of understanding and is willing to sign informed consent.

You may not qualify if:

• Subject with dark brown or black spots, such as large freckles, birth marks, moles or warts on the area to be treated.
• Subject with eczema, psoriasis, lesions, open wounds or active infections, such as cold sore in the area to be treated.
• Subject with a history of kelodial scar formation, a known sensitivity to light (photosensitivity) or is taking medication that makes the skin more sensitive to light, including non-steroidal anti-inflammatory agents, (e.g., aspirins, ibuprofens, acetaminophen), tetracyclines, phenothiazines, thiazide, diuretics, sulfonyluraes, sulfonamides, DTIC, fluorouracil, vinblastine, griseofulvin, Alpha-Hydroxi Acids (AHAs), Beta-Hydroxi Acids (BHAs), Retin-A®, Accutane® and/or topical retinoids.
• Subject with abnormal skin conditions caused by diabetes, for example, or other systemic or metabolic diseases.
• Subject currently or has recently been treated with Alpha-Hydroxi Acids (AHAs), Beta-Hydroxi Acids (BHAs), Retin-A®, topical retinoids or azelaic acid.
• Subject has been treated with Accutane® (isotretinoin) within the past 6 months.
• Subject has been on a steroid regimen within the past 3 months.
• Subject has a history of herpes outbreaks in the area of treatment.
• Subject suffers from epilepsy.
• Subject with an active implant, such as a pacemaker, incontinence device, insulin pump, etc.
• Subject with a disease related to photosensitivity, such as porphyria, polymorphic light eruption, solar urticaria, lupus, etc.
• Subject with a history of skin cancer or areas of potential skin malignancies.
• Subject received radiation therapy or chemotherapy treatments within the past 3 months.
• Subject is pregnant or nursing (lactating).

Sponsors & Collaborators

• Home Skinovations Ltd.: lead

Results Point of Contact

• Title: Dr Liora Levi
• Organization: Home Skinovations

LioraL@silkn.com

+97249097470

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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 25, 2016
• First Posted: September 29, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 31, 2018
• Results First Posted: September 27, 2018

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share