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

This study has been completed.
Sponsor:
Information provided by:
Plasma Surgical Inc
ClinicalTrials.gov Identifier:
NCT00761878
First received: September 26, 2008
Last updated: July 3, 2009
Last verified: July 2009
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of skin condition and dermal architecture by ultrasound imaging [ Time Frame: At intervals for up to 12 months ] [ Designated as safety issue: No ]
  • Assessment of skin elasticity by non-invasive means [ Time Frame: At intervals for up to 12 months ] [ Designated as safety issue: No ]
  • Assessment of pain during treatment [ Time Frame: During treatment ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr Denis F Branson, Denis F Branson MD
ClinicalTrials.gov Identifier: NCT00761878     History of Changes
Other Study ID Numbers: PSI-2007-07
Study First Received: September 26, 2008
Last Updated: July 3, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Plasma Surgical Inc:
Skin aging
Skin wrinkling

ClinicalTrials.gov processed this record on August 28, 2014