Androgenetic AlopeciaPhase 2NCT03048461
The Effect of Platelet-rich Plasma in Subjects With Androgenetic Alopecia
A Phase 2 study testing Platelet Rich Plasma Prep System in people with Androgenetic Alopecia, run by Northwestern University.
Trial summary
The purpose of this study is to evaluate the effect of autologous platelet-rich plasma (PRP) in the treatment of androgenetic alopecia. This is a randomized clinical trial to evaluate the effect of autologous platelet rich plasma in subjects with moderate androgenetic alopecia. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Platelet Rich Plasma Prep System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2019to Dec 2020
- Phase
- Phase 2
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males or females ≥ 18 years old and ≤55 years old
- Subjects are in good health as judged by the investigator.
- Diagnosed with by a dermatologist with moderate androgenetic alopecia.
- Subject is seeking treatment for androgenetic alopecia.
- Subject has never previously used finasteride or minoxidil or has consistently used finasteride or minoxidil for at least 1 year.
- Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.
Who cannot join
- Other than androgenetic alopecia, evidence of another skin condition affecting the treatment area that would interfere with clinical assessments.
- Subjects who are unwilling to avoid initiating treatment with minoxidil or finasteride for the duration of the study; or in subjects who have been treated with minoxidil or finasteride for at least 1 year, unwilling to avoid changes in the dosing regimen of these medications for the duration of the study.
- Willing to refrain from washing hair or using hair product 24 hours before and after treatment visits
- History of a clinically significant hematologic disorder as determined by the investigator.
- Subjects currently receiving anticoagulant or anti-platelet therapy.
- Subjects on daily Aspirin therapy for cardiovascular disease.
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- Subjects with chronic NSAID use, unable to wean off.
- Subject is known to be HIV positive.
- History of recurrent facial or labial herpes simplex infection
- History of hypertrophic scars or keloids
- Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia, osteogenesis imperfecta, etc.
- Subjects who have any requirement for the use of local or systemic steroids or other immunosuppressive agent
- Pregnant or breast feeding
- Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
- Subjects who are unable to understand the protocol or give informed consent.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Clinical Trial Investigating the Effect of Autologous Platelet-rich Plasma in Subjects With Androgenetic Alopecia.
The purpose of this study is to evaluate the effect of autologous platelet-rich plasma (PRP) in the treatment of androgenetic alopecia.
This is a randomized clinical trial to evaluate the effect of autologous platelet rich plasma in subjects with moderate androgenetic alopecia. Approximately 30 subjects will be randomized into the study. The study is designed as an 18-month study consisting of 2 phases. This study was a pilot study designed to determine feasibility of this procedure.
Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.
- Conditions
- Androgenetic Alopecia
- Being tested
- Platelet Rich Plasma Prep System, Placebo
- 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 Plasma Prep SystemDevice
intradermal injections of platelet rich plasma to an area of alopecia
PlaceboDrug
intradermal injections to an area of alopecia
| Study group | Role | What they receive |
|---|---|---|
| Platelet Rich Plasma | Experimental | Participants will receive intradermal injections autologous PRP to an area (100cm2) of alopecia on the scalp.Two treatments will be performed 3 months apart Receives: Device: Platelet Rich Plasma Prep System |
| Placebo (sterile saline) | Placebo comparator | Participants will receive intradermal injections of sterile normal saline to an area (100cm2) of alopecia on the scalp. Two treatments will be performed 3 months apart Receives: Device: Platelet Rich Plasma Prep System; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical change of androgenetic alopecia, as determined by scoring photographs
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study startJun 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Did not want to enroll and proceed with this study concept.
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 Northwestern UniversityThe 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048461
- Sponsor's protocol ID
- MA04222016
- Status last verified
- Dec 2021
- First submitted
- 7 Feb 2017
- Last updated
- 23 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Clinical Trial Investigating the Effect of Autologous Platelet-rich Plasma in Subjects With Androgenetic Alopecia.
- ClinicalTrials.gov ID
- NCT03048461
- Acronym / sponsor ID
- MA04222016
- Conditions
- Androgenetic Alopecia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Did not want to enroll and proceed with this study concept.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 9 Feb 2017 (estimated)
- 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.
The purpose of this study is to evaluate the effect of autologous platelet-rich plasma (PRP) in the treatment of androgenetic alopecia.
This is a randomized clinical trial to evaluate the effect of autologous platelet rich plasma in subjects with moderate androgenetic alopecia. Approximately 30 subjects will be randomized into the study. The study is designed as an 18-month study consisting of 2 phases. This study was a pilot study designed to determine feasibility of this procedure.
Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet Rich Plasma | Experimental | Device: Platelet Rich Plasma Prep SystemParticipants will receive intradermal injections autologous PRP to an area (100cm2) of alopecia on the scalp.Two treatments will be performed 3 months apart |
| Placebo (sterile saline) | Placebo comparator | Device: Platelet Rich Plasma Prep System, Drug: PlaceboParticipants will receive intradermal injections of sterile normal saline to an area (100cm2) of alopecia on the scalp. Two treatments will be performed 3 months apart |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males or females ≥ 18 years old and ≤55 years old
- Subjects are in good health as judged by the investigator.
- Diagnosed with by a dermatologist with moderate androgenetic alopecia.
- Subject is seeking treatment for androgenetic alopecia.
- Subject has never previously used finasteride or minoxidil or has consistently used finasteride or minoxidil for at least 1 year.
Key exclusion criteria (15 listed)
- Other than androgenetic alopecia, evidence of another skin condition affecting the treatment area that would interfere with clinical assessments.
- Subjects who are unwilling to avoid initiating treatment with minoxidil or finasteride for the duration of the study; or in subjects who have been treated with minoxidil or finasteride for at least 1 year, unwilling to avoid changes in the dosing regimen of these medications for the duration of the study.
- Willing to refrain from washing hair or using hair product 24 hours before and after treatment visits
- History of a clinically significant hematologic disorder as determined by the investigator.
- Subjects currently receiving anticoagulant or anti-platelet therapy.
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 Plasma Prep Systemintradermal injections of platelet rich plasma to an area of alopecia | Device | Placebo (sterile saline), Platelet Rich Plasma |
| Placebointradermal injections to an area of alopecia | Drug | Placebo (sterile saline) |
Primary outcome
Clinical change of androgenetic alopecia, as determined by scoring photographs
Time frame: Baseline to 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2021.
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Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
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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.
Murad Alam, MD principal investigator
Northwestern University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Platelet Rich Plasma Prep System in people with Androgenetic Alopecia, run by Northwestern University.
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 6 inclusion and 15 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: withdrawn, as of the sponsor's last update on 23 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Clinical change of androgenetic alopecia, as determined by scoring photographs (time frame: Baseline to 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 23 Dec 2021.