Using a Cold Atmospheric Plasma Device to Treat Skin Disorders

• Sponsor: The Skin Center Dermatology Group (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT02759900
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 108
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• Anticipated 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: Jan 1, 2016
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Jan 1, 2025

Arms and Interventions

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

Primary Outcome Measures

1. Clinical improvement [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

Criteria

• Ages Eligible for Study: 4 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• diagnoses of target conditions

• ability to complete study protocol

Exclusion Criteria:

• based on specific condition

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Skin Center Dermatology Group	New City	New York	United States	10956

Sponsors and Collaborators

• The Skin Center Dermatology Group

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Skin Center Dermatology Group
• ClinicalTrials.gov Identifier: NCT02759900
• Other Study ID Numbers: 20130084
• First Posted: May 3, 2016
• Last Update Posted: Apr 12, 2022
• Last Verified: Apr 1, 2022

• Additional relevant MeSH terms: Molluscum Contagiosum; Keratosis, Actinic; Bowen's Disease; Keratosis; Rosacea; Skin Diseases

Study Results

No Results Posted as of Apr 12, 2022