NCT00761878

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

July 7, 2009

Status Verified

July 1, 2009

Enrollment Period

1.5 years

First QC Date

September 26, 2008

Last Update Submit

July 3, 2009

Conditions

Skin Aging

Keywords

Skin agingSkin wrinkling

Outcome Measures

Primary Outcomes (1)

  • Assessment of skin appearance and condition by photography and digital image analysis

    At intervals for up to 12 months

Secondary Outcomes (3)

  • Assessment of skin condition and dermal architecture by ultrasound imaging

    At intervals for up to 12 months

  • Assessment of skin elasticity by non-invasive means

    At intervals for up to 12 months

  • Assessment of pain during treatment

    During treatment

Study Arms (1)

Skin treatment

ACTIVE COMPARATOR
Procedure: Exposure to plasma energy

Interventions

Exposure to plasma energyPROCEDURE

Non-invasive exposure to pulsed plasma to the unbroken skin over half of the facial area

Skin treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • request for treatment to improve facial skin

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Denis F Branson MD

Fayetteville, New York, 13066, United States

Location

Study Officials

  • Denis F Branson, MD

    Denis F Branson MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 26, 2008

First Posted

September 30, 2008

Study Start

December 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

July 7, 2009

Record last verified: 2009-07

Locations

US(1)