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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00761878
First Posted: September 30, 2008
Last Update Posted: July 7, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Plasma Surgical Inc
  Purpose
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

Condition Intervention
Skin Aging Procedure: Exposure to plasma energy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the PlasmaJet Neutral Argon Plasma System for Skin Regeneration and Comparison With the Rhytec Portrait PSR Plasma System

Resource links provided by NLM:


Further study details as provided by Plasma Surgical Inc:

Primary Outcome Measures:
  • Assessment of skin appearance and condition by photography and digital image analysis [ Time Frame: At intervals for up to 12 months ]

Secondary Outcome Measures:
  • Assessment of skin condition and dermal architecture by ultrasound imaging [ Time Frame: At intervals for up to 12 months ]
  • Assessment of skin elasticity by non-invasive means [ Time Frame: At intervals for up to 12 months ]
  • Assessment of pain during treatment [ Time Frame: During treatment ]

Enrollment: 35
Study Start Date: December 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Skin treatment Procedure: Exposure to plasma energy
Non-invasive exposure to pulsed plasma to the unbroken skin over half of the facial area

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • request for treatment to improve facial skin

Exclusion Criteria:

  • pregnancy
  • history of HIV infection
  • autoimmune or connective tissue disorder
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00761878


Locations
United States, New York
Denis F Branson MD
Fayetteville, New York, United States, 13066
Sponsors and Collaborators
Plasma Surgical Inc
Investigators
Principal Investigator: Denis F Branson, MD Denis F Branson MD
  More Information

Responsible Party: Dr Denis F Branson, Denis F Branson MD
ClinicalTrials.gov Identifier: NCT00761878     History of Changes
Other Study ID Numbers: PSI-2007-07
First Submitted: September 26, 2008
First Posted: September 30, 2008
Last Update Posted: July 7, 2009
Last Verified: July 2009

Keywords provided by Plasma Surgical Inc:
Skin aging
Skin wrinkling