- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06149221
Penetration-enhanced Direct DBD Non-thermal Plasma for Hair Loss
April 15, 2024 updated by: Dr. Peter C. Friedman
Using Direct Non-thermal Atmospheric Pressure Plasma With Penetration Enhancement for the Treatment of Hair Loss
In-office applied non-thermal atmospheric pressure plasma treatment on NS pretreated scalp
Study Overview
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New City, New York, United States, 10956
- The Skin Center Dermatology Group
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NTAP treatment
Treatment arm subjects receive the trial intervention
|
Cold plasma is generated and applied to the scalp area, which was previously soaked with normal saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of detectable hair growth
Time Frame: 3 months and 6 months
|
Presence of hair growth as measured using the HairMetrix device
|
3 months and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
throughout study completeion, 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2023
Primary Completion (Actual)
April 12, 2024
Study Completion (Actual)
April 12, 2024
Study Registration Dates
First Submitted
November 20, 2023
First Submitted That Met QC Criteria
November 20, 2023
First Posted (Actual)
November 28, 2023
Study Record Updates
Last Update Posted (Actual)
April 17, 2024
Last Update Submitted That Met QC Criteria
April 15, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DCAP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Androgenetic Alopecia
-
University of FloridaWithdrawnFemale Androgenetic AlopeciaUnited States
-
Suzhou Kintor Pharmaceutical Inc,Completed
-
King Edward Medical UniversityCompletedCombination of SVF and PRP for Androgenetic AlopeciaPakistan
-
Second Affiliated Hospital, School of Medicine,...Recruiting
-
Hope Medicine (Nanjing) Co., LtdRecruitingAndrogenetic AlopeciaChina
-
Indonesia UniversityRecruiting
-
Cassiopea SpAICON Clinical Research; Canfield Scientific Inc.; Ergomed PLC; Pharmapace IncRecruitingAlopecia, AndrogeneticGermany, United States, Poland
-
University of ArizonaTransdermal Cap, Inc.Not yet recruitingAndrogenetic Alopecia
-
Gregory L Smith, MD, MPHRecruitingAndrogenetic AlopeciaUnited States
-
Indonesia UniversityCompletedAndrogenetic AlopeciaIndonesia
Clinical Trials on NTAP
-
Medical University of South CarolinaThe Skin Center Dermatology GroupRecruitingVerruca Vulgaris | Molluscum ContagiosumUnited States
-
Medical University of South CarolinaThe Skin Center Dermatology GroupCompletedVerruca Vulgaris | Molluscum Contagiosum Skin InfectionUnited States