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

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ClinicalTrials.gov Identifier: NCT00761878
Recruitment Status : Completed
First Posted : September 30, 2008
Last Update Posted : July 7, 2009
Sponsor:
Information provided by:
Plasma Surgical Inc

Brief 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

Condition or disease Intervention/treatment Phase
Skin Aging Procedure: Exposure to plasma energy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
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
Study Start Date : December 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Aging
U.S. FDA Resources

Arm Intervention/treatment
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



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

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


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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

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

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 Posted: September 30, 2008    Key Record Dates
Last Update Posted: July 7, 2009
Last Verified: July 2009

Keywords provided by Plasma Surgical Inc:
Skin aging
Skin wrinkling