Clinical trial NCT03002194: Change in Skin Elasticity With RF and PEMF
Official title: Change in Skin Elasticity After Combined Radiofrequency and Electromagnetic Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Abnormalities
Keywords: rhytides
wrinkle
Lead sponsor: Venus Concept
Sponsor class: INDUSTRY
First posted: 2016-12-23
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Facial Skin Elasticity
timeFrame: 20 weeks after the last study treatment
Secondary outcomes:
measure: Improvement in Subject Satisfaction With Facial Skin Laxity Compared to Baseline as Measured by the 5-point Likert Satisfaction Scale
timeFrame: 7 weeks and 20 weeks post study treatments
measure: General Aesthetic Improvement Scale (GAIS)
timeFrame: 7 weeks and 20 weeks post study treatments.
Other outcomes:
Locations:
city: North York
country: Canada
facility: Art of Facial Surgery
state: Ontario
Study officials:
affiliation: Venus Concept Ltd.
name: Yoni Iger, PhD
role: STUDY_DIRECTOR
References: