Penetration-enhanced Direct DBD Non-thermal Plasma for Hair Loss

• Sponsor: Dr. Peter C. Friedman (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT06149221
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 10.4
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

In-office applied non-thermal atmospheric pressure plasma treatment on NS pretreated scalp

Condition or Disease	Intervention/Treatment	Phase
Androgenetic Alopecia	Device: NTAP	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Using Direct Non-thermal Atmospheric Pressure Plasma With Penetration Enhancement for the Treatment of Hair Loss
• Actual Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Mar 30, 2024
• Anticipated Study Completion Date: Jul 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NTAP treatment Treatment arm subjects receive the trial intervention	Device: NTAP; Cold plasma is generated and applied to the scalp area, which was previously soaked with normal saline

Outcome Measures

Primary Outcome Measures

1. Presence of detectable hair growth [3 months and 6 months]

   Presence of hair growth as measured using the HairMetrix device

Secondary Outcome Measures

1. Adverse effects related to the treatment [throughout study completeion, 6 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• diagnosis of mild-to moderate androgenetic alopecia

• 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

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

• Dr. Peter C. Friedman

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Peter C. Friedman, President, The Skin Center Dermatology Group
• ClinicalTrials.gov Identifier: NCT06149221
• Other Study ID Numbers: DCAP
• First Posted: Nov 28, 2023
• Last Update Posted: Nov 28, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alopecia

Study Results

No Results Posted as of Nov 28, 2023