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

July 3, 2009 updated by: Plasma Surgical Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Fayetteville, New York, United States, 13066
        • Denis F Branson MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • request for treatment to improve facial skin

Exclusion Criteria:

  • pregnancy
  • history of HIV infection
  • autoimmune or connective tissue disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of skin appearance and condition by photography and digital image analysis
Time Frame: At intervals for up to 12 months
At intervals for up to 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Plasma Surgical Inc

Investigators

  • Principal Investigator: Denis F Branson, MD, Denis F Branson MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ACTUAL)

June 1, 2009

Study Registration Dates

First Submitted

September 26, 2008

First Submitted That Met QC Criteria

September 26, 2008

First Posted (ESTIMATE)

September 30, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 7, 2009

Last Update Submitted That Met QC Criteria

July 3, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PSI-2007-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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