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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01460927
Other study ID # TriActive+RF-DEKA-092011
Secondary ID
Status Completed
Phase N/A
First received October 24, 2011
Last updated June 4, 2014
Start date October 2011
Est. completion date April 2012

Study information

Verified date June 2014
Source Deka Medical, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The study objective is to evaluate the safety and efficacy of a radiofrequency (RF) source, the TriActive+ RF handpiece, for treatment of wrinkles and rhytides after multiple treatments. The primary endpoint is observation of changes to the surface by visual and photographic analysis. Secondary endpoints: measurement of patient satisfaction and comfort of the treatment and the measurement of adverse events.


Description:

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Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
TriActive+ RF
Radio frequency handpiece uses a multi-polar technology with a particular electrical frequency of 1MHz. The handpiece has a special "skin contact identification" system which delivers energy only when electrodes are adherent to the skin surface in order to avoid the prickling sensation when the treatment starts.

Locations

Country Name City State
United States Southwest Medical Group Plastic Surgery Vancouver Washington

Sponsors (1)

Lead Sponsor Collaborator
Deka Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fitzpatrick Classification of Wrinkling and Degree of Elastosis. At each of the specified time points, photographs of the treated areas will be taken. The photography angles will include a global frontal photo and the right and left sides of the face at 45° and/or 90°. In addition, close up photos will be taken of specific facial zones, e.g., the peri orbital wrinkles.
Observing changes to the surface by visual and photographic analysis based on the score of 2-6 on the Fitzpatrick Classification of Wrinkling and Degree of Elastosis. (Lasers Surg Med 2003;33(4):232 42)
Score Wrinkling & Degree of Elastosis 1-3 Fine wrinkles (rhytides) and Mild Elastosis (fine textural changes with subtly accentuated skin lines) 4-6 Fine to moderate depth wrinkles, moderate number of lines and Moderate Elastosis (distinct papular elastosis [individual papules with yellow translucency under direct lighting] and dyschromia)
Baseline, Pre Treatment 4, Pre Treatment 8, 1 Month FU, 3 Month FU No
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