N/A
N=48
Change in Skin Elasticity With RF and PEMF
Skin Abnormalities
Bottom Line
View on ClinicalTrials.gov: NCT03002194 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Change in Facial Skin Elasticity — 0.7658; 0.7244 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cutometer (Device); Photographs (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Venus Concept
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Facial Skin Elasticity |
0.7658; 0.7244 | — |
| SECONDARY Improvement in Subject Satisfaction With Facial Skin Laxity Compared to Baseline as Measured by the 5-point Likert Satisfaction Scale |
3.11; 2.58 | — |
| SECONDARY General Aesthetic Improvement Scale (GAIS) |
1.19; 0.58 | — |
Summary
This study will measure the difference in skin elasticity in females only before and after treatment with radiofrequency and pulsed electromagnetic field therapy.
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.
Data sourced from ClinicalTrials.gov (NCT03002194). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.