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Cold Plasma to Treat Hair Loss

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ClinicalTrials.gov Identifier: NCT04379752
Recruitment Status : Recruiting
First Posted : May 7, 2020
Last Update Posted : March 16, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Peter C. Friedman, The Skin Center Dermatology Group

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

Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Device: Cold-atmospeheric pressure plasma activated aqueous-alcohol solution treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Using Indirect Cold Atmospheric Pressure Plasma (Plasma Activate Liquid) for the Treatment of Hair Loss
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : December 15, 2022
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cold-atmospeheric pressure plasma activated solution
Treatment arm subjects receive the trial intervention
Device: Cold-atmospeheric pressure plasma activated aqueous-alcohol solution treatment
Cold plasma is generated and applied to carrier liquid. Subjects are provided with the liquid to apply to the treated area




Primary Outcome Measures :
  1. Presence of detectable hair growth [ Time Frame: 3 months and 6 months ]
    Presence of hair growth is observed clinically. Evaluation may include photo comparison, hair count, trichoscopy


Secondary Outcome Measures :
  1. Adverse effects related to the treatment [ Time Frame: throughout study completeion, 6 months ]
    Patients are monitored for adverse effects, including but not limited to irritation, itch, inflammation, scaling, redness, rash, peeling, blistering



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04379752


Locations
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United States, New York
The Skin Center Dermatology Group Recruiting
New City, New York, United States, 10956
Contact: Peter C Friedman, MD, PhD    845-352-0500    pbc9@columbia.edu   
Sponsors and Collaborators
Dr. Peter C. Friedman
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Peter C. Friedman, President, The Skin Center Dermatology Group
ClinicalTrials.gov Identifier: NCT04379752    
Other Study ID Numbers: 20200501
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alopecia
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical