NCT02759900

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 3, 2016

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

8.2 years

First QC Date

April 26, 2016

Last Update Submit

April 10, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    1-12 months

Study Arms (2)

Non-thermal atmospheric plasma treatment

EXPERIMENTAL

Device treatment

Device: Non-thermal, atmospheric plasma to treat skin lesions and acne

Indirect non-thermal atmospheric plasma treatment

EXPERIMENTAL

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

Interventions

Non-thermal, atmospheric plasma treatment of affected area or lesions using a nanosecond dielectric barrier discharge plasma device

Non-thermal atmospheric plasma treatment

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

Indirect non-thermal atmospheric plasma treatment

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • diagnoses of target conditions
  • ability to complete study protocol

You may not qualify if:

  • based on specific condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Skin Center Dermatology Group

New City, New York, 10956, United States

RECRUITING

Related Publications (2)

  • Friedman PC, Fridman G, Fridman A. Cold atmospheric pressure plasma clears molluscum contagiosum. Exp Dermatol. 2023 Apr;32(4):562-563. doi: 10.1111/exd.14695. Epub 2022 Nov 3. No abstract available.

  • 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.

MeSH Terms

Conditions

Keratosis, ActinicRosaceaTineaMolluscum ContagiosumBowen's DiseaseWarts

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue DiseasesDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousPoxviridae InfectionsDNA Virus InfectionsVirus DiseasesSkin Diseases, ViralCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous CellPapillomavirus InfectionsTumor Virus Infections

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2016

First Posted

May 3, 2016

Study Start

January 1, 2016

Primary Completion

March 1, 2024

Study Completion

January 1, 2025

Last Updated

April 12, 2022

Record last verified: 2022-04

Locations