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Using a Cold Atmospheric Plasma Device to Treat Skin Disorders

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ClinicalTrials.gov Identifier: NCT02759900
Recruitment Status : Recruiting
First Posted : May 3, 2016
Last Update Posted : April 12, 2022
Sponsor:
Information provided by (Responsible Party):
The Skin Center Dermatology Group

Study Description
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Brief Summary:
This study examines the efficacy of a non-thermal, atmospheric plasma device in the treatment of skin disorders

Condition or disease Intervention/treatment Phase
Actinic Keratosis Acne/Rosacea Verruca Plana Tinea Molluscum Contagiosum Bowen's Disease Warts Device: Non-thermal, atmospheric plasma to treat skin lesions and acne Device: Indirect non-thermal, atmospheric plasma to treat hair loss and acne Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Using a Cold Atmospheric Plasma Device to Treat Skin Disorders
Actual Study Start Date : January 2016
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Conditions

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnoses of target conditions
  • ability to complete study protocol

Exclusion Criteria:

  • based on specific condition
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02759900


Locations
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United States, New York
The Skin Center Dermatology Group Recruiting
New City, New York, United States, 10956
Contact: Peter C Friedman, MD, PhD    845-352-0500    pbc9@columbia.edu   
Sponsors and Collaborators
The Skin Center Dermatology Group
More Information
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Responsible Party: The Skin Center Dermatology Group
ClinicalTrials.gov Identifier: NCT02759900    
Other Study ID Numbers: 20130084
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: April 12, 2022
Last Verified: April 2022
Additional relevant MeSH terms:
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Bowen's Disease
Skin Diseases
Precancerous Conditions
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Molluscum Contagiosum
Keratosis, Actinic
Keratosis
Rosacea
 Neoplasms
DNA Virus Infections
Infections
Poxviridae Infections
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell