Skin AgingNCT00761878
Evaluation of the PlasmaJet Neutral Argon Plasma System to Treat Skin Ageing
A study testing Exposure to plasma energy in people with Skin Aging, run by Plasma Surgical Inc at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Aging
- What is being tested?
- Exposure to plasma energy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- request for treatment to improve facial skin
Who cannot join
- pregnancy
- history of HIV infection
- autoimmune or connective tissue disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Skin Aging
- Being tested
- Exposure to plasma energy
- Keywords
- Skin aging, Skin wrinkling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to plasma energyProcedure or surgery
Non-invasive exposure to pulsed plasma to the unbroken skin over half of the facial area
| Study group | Role | What they receive |
|---|---|---|
| Skin treatment | Active comparator | Not described Receives: Procedure: Exposure to plasma energy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of skin appearance and condition by photography and digital image analysis
Measured: At intervals for up to 12 months
Secondary outcomes (3)
Assessment of skin condition and dermal architecture by ultrasound imaging
Measured: At intervals for up to 12 months
Assessment of skin elasticity by non-invasive means
Measured: At intervals for up to 12 months
Assessment of pain during treatment
Measured: During treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startDec 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Plasma Surgical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Denis F Branson, MD, Principal investigator, Denis F Branson MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761878
- Sponsor's protocol ID
- PSI-2007-07
- Status last verified
- Jul 2009
- First submitted
- 26 Sep 2008
- Last updated
- 7 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the PlasmaJet Neutral Argon Plasma System for Skin Regeneration and Comparison With the Rhytec Portrait PSR Plasma System
- ClinicalTrials.gov ID
- NCT00761878
- Acronym / sponsor ID
- PSI-2007-07
- Conditions
- Skin Aging
- Keywords
- Skin aging, Skin wrinkling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Plasma Surgical IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skin treatment | Active comparator | Procedure: Exposure to plasma energy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- request for treatment to improve facial skin
Key exclusion criteria (3 listed)
- pregnancy
- history of HIV infection
- autoimmune or connective tissue disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure to plasma energyNon-invasive exposure to pulsed plasma to the unbroken skin over half of the facial area | Procedure or surgery | Skin treatment |
Primary outcome
Assessment of skin appearance and condition by photography and digital image analysis
Time frame: At intervals for up to 12 months
3 secondary outcomes
Assessment of skin condition and dermal architecture by ultrasound imaging
Time frame: At intervals for up to 12 months
Assessment of skin elasticity by non-invasive means
Time frame: At intervals for up to 12 months
Assessment of pain during treatment
Time frame: During treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis F Branson, MD principal investigator
Denis F Branson MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure to plasma energy in people with Skin Aging, run by Plasma Surgical Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of skin appearance and condition by photography and digital image analysis (time frame: At intervals for up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2009.