Using a Cold Atmospheric Plasma Device to Treat Skin Disorders

April 10, 2022 updated by: The Skin Center Dermatology Group
This study examines the efficacy of a non-thermal, atmospheric plasma device in the treatment of skin disorders

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study uses non-thermal atmospheric pressure plasma to treat target conditions. The patients are monitored at set intervals for efficacy and adverse effects using investigator's assessment and imaging techniques

Study Type

Interventional

Enrollment (Anticipated)

100

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
      • New City, New York, United States, 10956
        • Recruiting
        • The Skin Center Dermatology Group
        • Contact:

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

4 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnoses of target conditions
  • ability to complete study protocol

Exclusion Criteria:

  • based on specific condition

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-thermal atmospheric plasma treatment
Device treatment
Device: Non-thermal, atmospheric plasma to treat skin lesions and acne
Non-thermal, atmospheric plasma treatment of affected area or lesions using a nanosecond dielectric barrier discharge plasma device
Experimental: Indirect non-thermal atmospheric plasma treatment
A compound of non-thermal atmospheric plasma and medium is used to treat the target by direct application or by on-site generation of the compound
Device: Indirect non-thermal, atmospheric plasma to treat hair loss and acne
A compound of non-thermal, atmospheric plasma and medium is delivered to or generated at the target area. Plasma is generated using either microsecond dielectric barrier discharge plasma device or PiezoBrush (a helium jet plasma). The medium is an aqueous alcohol solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical improvement
Time Frame: 1-12 months
The outcome is the presence or lack of clinical improvement in the investigator's global assessment and reviewing photo-documentation as well as reflectance confocal microscopy study investigator's global assessment and reviewing photo-documentation
1-12 months

Collaborators and Investigators

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

Sponsor

The Skin Center Dermatology Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 1, 2016

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

April 26, 2016

First Submitted That Met QC Criteria

May 2, 2016

First Posted (Estimate)

May 3, 2016

Study Record Updates

Last Update Posted (Actual)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 10, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20130084

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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