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Using a Cold Atmospheric Plasma Device to Treat Skin Disorders

Primary Purpose

Actinic Keratosis, Acne/Rosacea, Verruca Plana

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Non-thermal, atmospheric plasma to treat skin lesions and acne
Indirect non-thermal, atmospheric plasma to treat hair loss and acne
Sponsored by
The Skin Center Dermatology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnoses of target conditions
  • ability to complete study protocol

Exclusion Criteria:

  • based on specific condition

Sites / Locations

  • The Skin Center Dermatology GroupRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Non-thermal atmospheric plasma treatment

Indirect non-thermal atmospheric plasma treatment

Arm Description

Device 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

Outcomes

Primary Outcome Measures

Clinical improvement
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

Secondary Outcome Measures

Full Information

First Posted
April 26, 2016
Last Updated
April 10, 2022
Sponsor
The Skin Center Dermatology Group
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1. Study Identification

Unique Protocol Identification Number
NCT02759900
Brief Title
Using a Cold Atmospheric Plasma Device to Treat Skin Disorders
Official Title
Using a Cold Atmospheric Plasma Device to Treat Skin Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2016 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Skin Center Dermatology Group

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis, Acne/Rosacea, Verruca Plana, Tinea, Molluscum Contagiosum, Bowen's Disease, Warts

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-thermal atmospheric plasma treatment
Arm Type
Experimental
Arm Description
Device treatment
Arm Title
Indirect non-thermal atmospheric plasma treatment
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Non-thermal, atmospheric plasma to treat skin lesions and acne
Intervention Description
Non-thermal, atmospheric plasma treatment of affected area or lesions using a nanosecond dielectric barrier discharge plasma device
Intervention Type
Device
Intervention Name(s)
Indirect non-thermal, atmospheric plasma to treat hair loss and acne
Intervention Description
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
Primary Outcome Measure Information:
Title
Clinical improvement
Description
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
Time Frame
1-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnoses of target conditions ability to complete study protocol Exclusion Criteria: based on specific condition
Facility Information:
Facility Name
The Skin Center Dermatology Group
City
New City
State/Province
New York
ZIP/Postal Code
10956
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter C Friedman, MD, PhD
Phone
845-352-0500
Email
pbc9@columbia.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
35491738
Citation
Malik S, Gill M, Fridman G, Fridman A, Friedman PC. Cold atmospheric plasma reduces demodex count on the face comparably to topical ivermectin, as measured by reflectance confocal microscopy. Exp Dermatol. 2022 Sep;31(9):1352-1354. doi: 10.1111/exd.14584. Epub 2022 May 11. No abstract available.
Results Reference
derived

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Using a Cold Atmospheric Plasma Device to Treat Skin Disorders

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