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
About this trial
This is an interventional treatment trial for Androgenetic Alopecia
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
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
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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