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NCT00761878 Clinical Trial

Evaluation of the PlasmaJet Neutral Argon Plasma System to Treat Skin Ageing

Skin Aging Clinical Trial

Official title:
Evaluation of the PlasmaJet Neutral Argon Plasma System for Skin Regeneration and Comparison With the Rhytec Portrait PSR Plasma System

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00761878
Other study ID # PSI-2007-07
Secondary ID
Status Completed
Phase N/A
First received September 26, 2008
Last updated July 3, 2009
Start date December 2007
Est. completion date June 2009

Study information
Verified date July 2009
Source Plasma Surgical Inc
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the comparative effects of the PlasmaJet neutral argon plasma system and the Rhytec Portrait PRS nitrogen plasma system in the treatment of aging facial skin

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- request for treatment to improve facial skin

Exclusion Criteria:

- pregnancy

- history of HIV infection

- autoimmune or connective tissue disorder

Study Design

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

Related Conditions & MeSH terms

Intervention

Procedure:
• Exposure to plasma energy
Non-invasive exposure to pulsed plasma to the unbroken skin over half of the facial area

Locations
Country Name City State
United States Denis F Branson MD Fayetteville New York

Sponsors (1)
Lead Sponsor Collaborator
Plasma Surgical Inc

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of skin appearance and condition by photography and digital image analysis At intervals for up to 12 months No
Secondary Assessment of skin condition and dermal architecture by ultrasound imaging At intervals for up to 12 months No
Secondary Assessment of skin elasticity by non-invasive means At intervals for up to 12 months No
Secondary Assessment of pain during treatment During treatment No
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