Change in Skin Elasticity With RF and PEMF

Skin Abnormalities Clinical Trial

Official title:

Change in Skin Elasticity After Combined Radiofrequency and Electromagnetic Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03002194
• Other study ID #: CS0316
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: September 29, 2017

Study information

• Verified date: April 2020
• Source: Venus Concept
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This study is an open-label, baseline-controlled, single-center study to measure the change in skin elasticity after combined radio frequency (RF) and pulsed electromagnetic field (PEMF) treatment. Forty-five adult females will undergo weekly treatments over a period of 8 weeks. Skin elasticity will be measured by a Cutometer® prior to beginning treatment, week 7 and 3 months after completion of treatment. Photographs will be taken prior to treatment, at week 4, week 7 and 3 months after completion of treatment. Patient discomfort/pain and satisfaction questionnaires will be completed before, during and after treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 29, 2017
• Est. primary completion date: September 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Skin Abnormalities

Intervention

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

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

Locations

Country	Name	City	State
Canada	Art of Facial Surgery	North York	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Venus Concept

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Improvement in Subject Satisfaction With Facial Skin Laxity Compared to Baseline as Measured by the 5-point Likert Satisfaction Scale	Subject will assign a score that best represents the level of satisfaction they have in their appearance as a result of the study treatment. The scale reports five categories - 4 - very satisfied; 3 - satisfied; 2 - having no opinion; 1 - unsatisfied and 0 - very unsatisfied. The higher the score, the more satisfaction with the treatment that a subject reports.	7 weeks and 20 weeks post study treatments
Secondary	General Aesthetic Improvement Scale (GAIS)	Subject to assess their general improvement in appearance at 7 and 20 weeks post-intervention using a 7 category scale: 3 - very much improved; 2 - much improved; 1 - improved; 0 - no change; -1 - worse; -2 - much worse and -3 very much worse. The higher the positive score, the more the subject feels their appearance has changed for the better.	7 weeks and 20 weeks post study treatments.