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Androgenetic AlopeciaPhase 4NCT02999737

Comparing Different Platelet Rich Plasma (PRP) Treatment Regimens for Management of Androgenic Alopecia

A Phase 4 study testing Platelet Rich Plasma for 4 sessions and Platelet rich plasma for 2 sessions in people with Androgenetic Alopecia, run by Skin Care and Laser Physicians of Beverly Hills at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The injection of autologous platelet rich plasma (PRP) is a relatively novel therapy, generating interest across a wide variety of medical specialties, such as orthopedics, dentistry, ophthalmology, and dermatology. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Androgenetic Alopecia
What is being tested?
Platelet Rich Plasma for 4 sessions and Platelet rich plasma for 2 sessions
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
Nov 2016to Aug 2017
Phase
Phase 4
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, aged 18-65 years with AGA
  • Completed and signed consent form
  • Norwood Hamilton stage II-V in men or Ludwig stage I2-II1 in women
  • In general good health
  • Willing and able to attend all study visits
  • Willing to maintain the same hair style and hair care routine as at the screening visit for the duration of the study
  • Willing to have blood drawn

Who cannot join

  • Younger than 18 years or older than 65 years
  • Diagnosis of alopecia areata or other non-AGA forms of hair loss
  • Current skin disease, cuts, or abrasions on the scalp (i.e. psoriasis, severe seborrheic dermatitis) that may limit data interpretation or put the subject at increased risk
  • Scalp infection
  • Malignancy, except for non-scalp nonmelanoma or melanoma skin cancers, or undergoing chemotherapy or radiation treatments
  • Known history of autoimmune thyroid disease, any other thyroid disorder, or other autoimmune disorders that may interfere or increase risks associated with the study treatment
Show all 14Show fewer
  • Pregnancy, anticipated pregnancy, or breastfeeding
  • Tendency to develop keloids
  • History of surgical correction of hair loss on the scalp
  • Use of products, devices, or medications intended to promote hair growth, except for subjects whose hair has been stable on FDA-approved therapies (i.e. oral finasteride and/or topical minoxidil) for 12 months
  • Use of anti-androgenic therapies (i.e. spironolactone, flutamide, cyproterone, acetate, cimetidine) within 90 days prior to he screening visit
  • Current anticoagulant therapy, except for subjects taking aspirin or other nonsteroidal anti-inflammatory drugs who are able to interrupt the medication for seven days before treatment or for subjects taking vitamin E or other over-the-counter supplements who are able to interrupt the medication for 14 days before treatment
  • Hereditary or acquired hematologic/coagulation disorders including: platelet dysfunction syndrome or thrombocytopenia (count < 150,000 platelets/Ul), hypofibrinogenemia, impaired coagulation, drepanocytosis (sickle cell anemia)
  • Hemodynamic instability

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Skincare and Laser Physicians of Beverly Hills

    Los Angeles, California, 90069

Other trials in United States

About this study

Official title: Evaluating the Efficacy of Different Platelet Rich Plasma (PRP) Treatment Regimens in the Management of Androgenetic Alopecia: an Investigator-initiated, Single-center, Single-blinded, Prospective, Randomized Clinical Trial

The injection of autologous platelet rich plasma (PRP) is a relatively novel therapy, generating interest across a wide variety of medical specialties, such as orthopedics, dentistry, ophthalmology, and dermatology. Several recently published studies have demonstrated efficacy in treating androgenetic alopecia (aka male or female patterned hair loss), but each varies in the treatment protocol, and there is no evidence-based data to date guiding the dosing parameters of and intervals between injection sessions. We propose a single-center, single-blinded randomized pilot trial to investigate the most beneficial number and frequency ('schedule') of necessary PRP injections in men and women with androgenetic alopecia.

Read the detailed description

Androgenetic alopecia is the most common form of hair loss, affecting up to 50% of men and 21 million women in the US alone. Irrespective of gender, balding is known to influence social interactions and cause substantial emotional distress, especially for those who begin losing their hair at an early age. Topical minoxidil and oral finasteride are currently the only Food and Drug Administration (FDA)-approved therapies for androgenetic alopecia in men, and oral agents are used off-label in women but are contraindicated during pregnancy and lactation. Response to these therapies varies, and they require continued use to maintain the benefits. Hair transplantation surgery is a more permanent, yet costly, solution. All of these treatments carry a risk of undesirable side effects, so there is demand for innovative new therapeutic options. Autologous platelet rich plasma (PRP) injection is a novel therapy for the treatment of patterned hair loss, but no studies to date evaluate different treatment protocols head-to-head. Hence, the purpose of this study is to compare the efficacy of two different PRP treatment schedules (frequency and number of injection sessions) in men and women with androgenetic alopecia.

Being tested
Platelet Rich Plasma for 4 sessions, Platelet rich plasma for 2 sessions
Keywords
Platelet Rich Plasma, PRP, Hair loss, Alopecia, Hypotrichosis, Hair diseases
Medical subject headings
Alopecia, Hypotrichosis, Hair Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Platelet Rich Plasma for 4 sessionsBiological

    Injection of autologous platelet rich plasma into areas of alopecia on the scalp every month x 3 sessions then every 3 months x 1 session (total 4 sessions)

  • Platelet rich plasma for 2 sessionsBiological

    Injection of autologous platelet rich plasma into areas of alopecia on the scalp every 3 months x 2 sessions (total 2 sessions)

Study groups in NCT02999737
Study groupRoleWhat they receive
Platelet Rich Plasma for 4 sessionsOtherAutologous Platelet Rich Plasma injected in the scalp monthly x 3 then every 3 months x 1
Receives: Biological: Platelet Rich Plasma for 4 sessions
Platelet rich plasma for 2 sessionsOtherAutologous Platelet Rich Plasma injected in the scalp every 3 months
Receives: Biological: Platelet rich plasma for 2 sessions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent change in terminal hair counts

    Evaluate the mean change in terminal hair counts (hairs/cm2) from baseline at 3 and 6 months after initial platelet rich plasma treatment

    Measured: 6 months

Secondary outcomes (5)

  1. Percent change in terminal hair shaft caliber

    Evaluate the mean change in terminal hair shaft caliber (microns) from baseline at 3 and 6 months after initial platelet rich plasma treatment

    Measured: 6 months

  2. Degree of hair shedding

    Evaluate the degree of hair shedding from baseline at 3 and 6 months after initial platelet rich plasma treatment

    Measured: 6 months

  3. Changes in investigator assessment of hair growth

    Evaluate changes in the blinded investigator's overall assessment of hair growth from baseline at 3 and 6 months

    Measured: 6 months

  4. Changes in subject assessment of hair growth and satisfaction

    Evaluate changes in the subject's overall assessment of hair growth and satisfaction from baseline at 3 and 6 months

    Measured: 6 months

  5. Safety and tolerability monitoring

    Monitor for adverse effects from and tolerability of injections

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionAug 2017 (estimated)
  4. Study completionAug 2017 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02999737
Sponsor's protocol ID
AGA-2016
Status last verified
Jan 2017
First submitted
19 Dec 2016
Last updated
12 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Sinclair R. Male pattern androgenetic alopecia. BMJ. 1998 Sep 26;317(7162):865-9. doi: 10.1136/bmj.317.7162.865. No abstract available.

    PubMed 9748188

  • Cash TF. The psychological effects of androgenetic alopecia in men. J Am Acad Dermatol. 1992 Jun;26(6):926-31. doi: 10.1016/0190-9622(92)70134-2.

    PubMed 1607410

  • Gkini MA, Kouskoukis AE, Tripsianis G, Rigopoulos D, Kouskoukis K. Study of platelet-rich plasma injections in the treatment of androgenetic alopecia through an one-year period. J Cutan Aesthet Surg. 2014 Oct-Dec;7(4):213-9. doi: 10.4103/0974-2077.150743.

    PubMed 25722600

  • Gentile P, Garcovich S, Bielli A, Scioli MG, Orlandi A, Cervelli V. The Effect of Platelet-Rich Plasma in Hair Regrowth: A Randomized Placebo-Controlled Trial. Stem Cells Transl Med. 2015 Nov;4(11):1317-23. doi: 10.5966/sctm.2015-0107. Epub 2015 Sep 23.

    PubMed 26400925

  • Alves R, Grimalt R. Randomized Placebo-Controlled, Double-Blind, Half-Head Study to Assess the Efficacy of Platelet-Rich Plasma on the Treatment of Androgenetic Alopecia. Dermatol Surg. 2016 Apr;42(4):491-7. doi: 10.1097/DSS.0000000000000665.

    PubMed 27035501

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Platelet Rich Plasma for 4 sessions and Platelet rich plasma for 2 sessions in people with Androgenetic Alopecia, run by Skin Care and Laser Physicians of Beverly Hills 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 7 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 12 Jan 2017. 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?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Percent change in terminal hair counts (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02999737, which also lists 5 linked publications.

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 12 Jan 2017.

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