Androgenetic AlopeciaNCT06149221
Penetration-enhanced Direct DBD Non-thermal Plasma for Hair Loss
A study testing NTAP in people with Androgenetic Alopecia, run by Dr. Peter C. Friedman at 1 site in United States.
Trial summary
In-office applied non-thermal atmospheric pressure plasma treatment on NS pretreated scalp Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- NTAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 12 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of mild-to moderate androgenetic alopecia
- ability to keep in-person follow-up appointments
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Skin Center Dermatology Group
New City, New York, 10956
About this study
Official title: 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
- Conditions
- Androgenetic Alopecia
- Being tested
- NTAP
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTAPDevice
Cold plasma is generated and applied to the scalp area, which was previously soaked with normal saline
| Study group | Role | What they receive |
|---|---|---|
| NTAP treatment | Experimental | Treatment arm subjects receive the trial intervention Receives: Device: NTAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of detectable hair growth
Presence of hair growth as measured using the HairMetrix device
Measured: 3 months and 6 months
Secondary outcomes (1)
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
Measured: throughout study completeion, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start1 Sep 2023
- Primary completion12 Apr 2024
- Study completion12 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Peter C. Friedman
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Dr. Peter C. Friedman, The Skin Center Dermatology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149221
- Sponsor's protocol ID
- DCAP
- Status last verified
- Apr 2024
- First submitted
- 20 Nov 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Direct Non-thermal Atmospheric Pressure Plasma With Penetration Enhancement for the Treatment of Hair Loss
- ClinicalTrials.gov ID
- NCT06149221
- Acronym / sponsor ID
- DCAP
- Conditions
- Androgenetic Alopecia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Dr. Peter C. FriedmanIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 12 Apr 2024 (actual)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In-office applied non-thermal atmospheric pressure plasma treatment on NS pretreated scalp
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NTAP treatment | Experimental | Device: NTAPTreatment arm subjects receive the trial intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of mild-to moderate androgenetic alopecia
- ability to keep in-person follow-up appointments
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NTAPCold plasma is generated and applied to the scalp area, which was previously soaked with normal saline | Device | NTAP treatment |
Primary outcome
Presence of detectable hair growth
Time frame: 3 months and 6 months
Presence of hair growth as measured using the HairMetrix device
1 secondary outcome
Adverse effects related to the treatment
Time frame: throughout study completeion, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NTAP in people with Androgenetic Alopecia, run by Dr. Peter C. Friedman at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of detectable hair growth (time frame: 3 months and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.