Change in Skin Elasticity With RF and PEMF

NCT03002194 | Completed Results

• 1 other identifier: CS0316
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This study will measure the difference in skin elasticity in females only before and after treatment with radiofrequency and pulsed electromagnetic field therapy.

Conditions

Skin Abnormalities

Keywords

rhytides; wrinkle

Outcome Measures

Primary Outcomes (1)

• Change in Facial Skin Elasticity

  A Cutometer® will be used to measure the change in gross elasticity (R2) of the facial skin as calculated by Ua/Uf which is a ratio of maximum recovery (Ua) and skin distensibility (Uf). The value is expressed as a percentage, the closer the value is to 1 (100%), the more elastic the skin.

  20 weeks after the last study treatment

Secondary Outcomes (2)

• Improvement in Subject Satisfaction With Facial Skin Laxity Compared to Baseline as Measured by the 5-point Likert Satisfaction Scale

  7 weeks and 20 weeks post study treatments

• General Aesthetic Improvement Scale (GAIS)

  7 weeks and 20 weeks post study treatments.

Study Arms (1)

RF and PEMF therapy

EXPERIMENTAL

Each subject is to receive 8 weekly study treatments. The study treatment consists of Glide (medical grade glycerin) being applied thoroughly to the study treatment area (face). The energy will be delivered by the Diamondpolar applicator attached to the Venus Versa, a medical device approved by health regulatory authorities, to deliver combined radiofrequency (RF) and pulsed electromagnetic field (PEMF) energies. Change in skin elasticity will be measured by Cutometer. Change in appearance will be assessed by independent reviewer using photographs.

Device: Cutometer; Other: Photographs

Interventions

Cutometer DEVICE

Skin elasticity will be measured by a Cutometer prior to beginning treatment, week 7 and 3 months after completion of the treatment.

RF and PEMF therapy

Photographs OTHER

Photographs will be taken prior to beginning treatment, week 7 and 3 months after completion of the treatment.

RF and PEMF therapy

Eligibility Criteria

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

You may qualify if:

• Healthy adult female subject, 18 years of age and older with Fitzpatrick skin types I-IV
• Ability to tolerate the RF/PEMF procedure, and willing to adhere to the treatment regimen

You may not qualify if:

• Having any active electrical implant or permanent implant anywhere in the body, e.g. pacemaker, internal defibrillator
• Prior use of retinoids in treated area within 2 weeks of initial treatment
• Use of oral Isotretinoin (Accutane®) within 6 months of initial treatment
• Patient on systemic corticosteroid therapy 6 months prior to start of study
• Prior use of collagen, fat injections and /or other methods of skin augmentation (enhancement with injected or implanted material) in treated area within 4-6 weeks of initial treatment. Treatment may not be performed at all over permanent dermal implants.
• Prior ablative resurfacing procedure in treated area with laser or other devices within 12 months of initial treatment
• Any other surgery in treated area within 12 months of initial treatment
• History of keloid formation or poor wound healing in a previously injured skin area
• Epidermal or dermal disorders
• Open laceration or abrasion of any sort on the area to be treated.
• History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
• Having any form of active cancer at the time of enrollment
• Significant concurrent illness, such as uncontrolled diabetes i.e. any disease state that in the opinion of the Investigator would interfere with the treatment, or healing process
• Participation in a study of another device or drug within 1 month prior to study enrollment
• Tattoos in the treatment area.

Sponsors & Collaborators

• Venus Concept: lead

Study Sites (1)

Art of Facial Surgery

North York, Ontario, M2N 6H7, Canada

Location

MeSH Terms

Conditions

Skin Abnormalities

Interventions

Moire Topography

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Photogrammetry; Photography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Interferometry; Investigative Techniques

Results Point of Contact

• Title: Yoni Iger
• Organization: Venus Concept Ltd

yoni@venusconcept.com

888-907-0115

Study Officials

• Yoni Iger, PhD

  Venus Concept Ltd.

  STUDY DIRECTOR

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: November 24, 2016
• First Posted: December 23, 2016
• Study Start: November 1, 2016
• Primary Completion: September 29, 2017
• Study Completion: September 29, 2017
• Last Updated: April 27, 2020
• Results First Posted: April 27, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)