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Cold Plasma to Treat Hair Loss

Primary Purpose

Androgenetic Alopecia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cold-atmospeheric pressure plasma activated aqueous-alcohol solution treatment
Sponsored by
Dr. Peter C. Friedman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Androgenetic Alopecia

Eligibility Criteria

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

Inclusion Criteria:

  • diagnosis of mild-to moderate androgenetic alopecia
  • ability of applying treatment regularly
  • ability to keep in-person follow-up appointments

Exclusion Criteria:

  • any inflammatory scalp condition
  • starting or discontinuing any hair loss treatments within 6 months of start date
  • allergy to any components of the carrier solution

Sites / Locations

  • The Skin Center Dermatology GroupRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cold-atmospeheric pressure plasma activated solution

Arm Description

Treatment arm subjects receive the trial intervention

Outcomes

Primary Outcome Measures

Presence of detectable hair growth
Presence of hair growth is observed clinically. Evaluation may include photo comparison, hair count, trichoscopy

Secondary Outcome Measures

Adverse effects related to the treatment
Patients are monitored for adverse effects, including but not limited to irritation, itch, inflammation, scaling, redness, rash, peeling, blistering

Full Information

First Posted
April 30, 2020
Last Updated
April 10, 2022
Sponsor
Dr. Peter C. Friedman
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1. Study Identification

Unique Protocol Identification Number
NCT04379752
Brief Title
Cold Plasma to Treat Hair Loss
Official Title
Using Indirect Cold Atmospheric Pressure Plasma (Plasma Activate Liquid) for the Treatment of Hair Loss
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Peter C. Friedman

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Self applied cold plasma activated medium used for androgenetic alopecia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cold-atmospeheric pressure plasma activated solution
Arm Type
Experimental
Arm Description
Treatment arm subjects receive the trial intervention
Intervention Type
Device
Intervention Name(s)
Cold-atmospeheric pressure plasma activated aqueous-alcohol solution treatment
Intervention Description
Cold plasma is generated and applied to carrier liquid. Subjects are provided with the liquid to apply to the treated area
Primary Outcome Measure Information:
Title
Presence of detectable hair growth
Description
Presence of hair growth is observed clinically. Evaluation may include photo comparison, hair count, trichoscopy
Time Frame
3 months and 6 months
Secondary Outcome Measure Information:
Title
Adverse effects related to the treatment
Description
Patients are monitored for adverse effects, including but not limited to irritation, itch, inflammation, scaling, redness, rash, peeling, blistering
Time Frame
throughout study completeion, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of mild-to moderate androgenetic alopecia ability of applying treatment regularly ability to keep in-person follow-up appointments Exclusion Criteria: any inflammatory scalp condition starting or discontinuing any hair loss treatments within 6 months of start date allergy to any components of the carrier solution
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

Plan to Share IPD
No
Citations:
PubMed Identifier
33346510
Citation
Khan A, Malik S, Walia J, Fridman G, Fridman A, Friedman PC. Tolerability of Six Months Indirect Cold (Physical) Plasma Treatment of the Scalp for Hair Loss. J Drugs Dermatol. 2020 Dec 1;19(12):1177-1180. doi: 10.36849/JDD.2020.5186.
Results Reference
derived

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Cold Plasma to Treat Hair Loss

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