Androgenetic AlopeciaEarly Phase 1NCT03376581
The Utility of Platelet Rich Plasma in Hair Loss
A Early Phase 1 study testing Platelet rich plasma in people with Androgenetic Alopecia, run by University of California, Irvine at 1 site in United States.
Trial summary
Platelet rich plasma (PRP) is an autologous preparation of human plasma with high concentration of platelets. Platelets release numerous growth factors, which stimulate cell proliferation and differentiation. The purpose of this research is to investigate the potential of PRP injection for treatment of hair loss. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Platelet rich plasma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2017to 20 Feb 2019
- Phase
- Early Phase 1
- 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 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years of age
- Ability to understand and carry out instructions
- Diagnosed with alopecia
Who cannot join
- Inability to understand and.or carry out instructions
- Pregnant women
- Use of any topical medication (such as minoxidil or any other solution for hair growth), oral medication (finasteride, dutasteride, or antiandrogens), laser therapy, or chemotherapy, within the preceding 4 weeks.
- Personal medical history of bleeding disorders
- Personal medical history of platelet dysfunction syndrome
- Anti-coagulation therapy or nonsteroidal anti-inflammatory drugs in the last 1 week.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine, Department of Dermatology, Dermatology Clinical Research Center, Hewitt Hall
Irvine, California, 92697
About this study
Platelet rich plasma (PRP) is an autologous preparation of human plasma with high concentration of platelets. Platelets release numerous growth factors, which stimulate cell proliferation and differentiation.
The purpose of this research is to investigate the potential of PRP injection for treatment of hair loss. Clinical outcomes will be assessed by noninvasive techniques including dermoscopy, multiphoton microscopy, optical coherence tomography, optical Doppler tomography and multispectral imaging.
- Conditions
- Androgenetic Alopecia
- Being tested
- Platelet rich plasma
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich plasmaProcedure or surgery
Blood drawn from each participant will be spun down to separate platelets. Platelets will be injected into that patient's scalp.
| Study group | Role | What they receive |
|---|---|---|
| Prospective treatment | Experimental | Not described Receives: Procedure: Platelet rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair density to measure the efficacy of treatment
Measured: 6 months
Secondary outcomes (6)
Hair count (number of hairs/0.65 cm2)
Measured: 6 months
Terminal hair density
Measured: 6 months
Anagen hair percentage
Measured: 6 months
Telogen hair percentage
Measured: 6 months
Anagen/telogen ratio
Measured: After 3 and 6 months
Changes in hair structure, diameter, and blood flow
As measured by optical coherence tomography
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start28 Nov 2017
- Primary completion20 Feb 2019
- Study completion20 Feb 2019
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.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natasha Mesinkovska, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376581
- Sponsor's protocol ID
- 20163239
- Status last verified
- Feb 2024
- First submitted
- 13 Dec 2017
- Last updated
- 2 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Platelet Rich Plasma in Hair Loss
- ClinicalTrials.gov ID
- NCT03376581
- Acronym / sponsor ID
- 20163239
- Conditions
- Androgenetic Alopecia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 20 Feb 2019 (actual)
- First posted
- 18 Dec 2017 (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.
Platelet rich plasma (PRP) is an autologous preparation of human plasma with high concentration of platelets. Platelets release numerous growth factors, which stimulate cell proliferation and differentiation.
The purpose of this research is to investigate the potential of PRP injection for treatment of hair loss. Clinical outcomes will be assessed by noninvasive techniques including dermoscopy, multiphoton microscopy, optical coherence tomography, optical Doppler tomography and multispectral imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective treatment | Experimental | Procedure: Platelet rich plasma |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years of age
- Ability to understand and carry out instructions
- Diagnosed with alopecia
Key exclusion criteria (6 listed)
- Inability to understand and.or carry out instructions
- Pregnant women
- Use of any topical medication (such as minoxidil or any other solution for hair growth), oral medication (finasteride, dutasteride, or antiandrogens), laser therapy, or chemotherapy, within the preceding 4 weeks.
- Personal medical history of bleeding disorders
- Personal medical history of platelet dysfunction syndrome
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 |
|---|---|---|
| Platelet rich plasmaBlood drawn from each participant will be spun down to separate platelets. Platelets will be injected into that patient's scalp. | Procedure or surgery | Prospective treatment |
Primary outcome
Hair density to measure the efficacy of treatment
Time frame: 6 months
6 secondary outcomes
Hair count (number of hairs/0.65 cm2)
Time frame: 6 months
Terminal hair density
Time frame: 6 months
Anagen hair percentage
Time frame: 6 months
Telogen hair percentage
Time frame: 6 months
Anagen/telogen ratio
Time frame: After 3 and 6 months
Changes in hair structure, diameter, and blood flow
Time frame: 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 2 Feb 2024.
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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 Early Phase 1 study testing Platelet rich plasma in people with Androgenetic Alopecia, run by University of California, Irvine 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 3 inclusion and 6 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 2 Feb 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Hair density to measure the efficacy of treatment (time frame: 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 2 Feb 2024.