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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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