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N/A N=48 Treatment

Change in Skin Elasticity With RF and PEMF

Skin Abnormalities

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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