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

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ClinicalTrials.gov Identifier: NCT02999737
Recruitment Status : Unknown
Verified January 2017 by Amelia K Hausauer, MD, Skin Care and Laser Physicians of Beverly Hills.
Recruitment status was:  Active, not recruiting
First Posted : December 21, 2016
Last Update Posted : January 12, 2017
Sponsor:
Collaborator:
Eclipse Aesthetics, LLC
Information provided by (Responsible Party):
Amelia K Hausauer, MD, Skin Care and Laser Physicians of Beverly Hills

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Biological: Platelet Rich Plasma for 4 sessions Biological: Platelet rich plasma for 2 sessions Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : November 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Platelet Rich Plasma for 4 sessions
Autologous Platelet Rich Plasma injected in the scalp monthly x 3 then every 3 months x 1
Biological: Platelet Rich Plasma for 4 sessions
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 sessions
Autologous Platelet Rich Plasma injected in the scalp every 3 months
Biological: Platelet rich plasma for 2 sessions
Injection of autologous platelet rich plasma into areas of alopecia on the scalp every 3 months x 2 sessions (total 2 sessions)




Primary Outcome Measures :
  1. Percent change in terminal hair counts [ Time Frame: 6 months ]
    Evaluate the mean change in terminal hair counts (hairs/cm2) from baseline at 3 and 6 months after initial platelet rich plasma treatment


Secondary Outcome Measures :
  1. Percent change in terminal hair shaft caliber [ Time Frame: 6 months ]
    Evaluate the mean change in terminal hair shaft caliber (microns) from baseline at 3 and 6 months after initial platelet rich plasma treatment

  2. Degree of hair shedding [ Time Frame: 6 months ]
    Evaluate the degree of hair shedding from baseline at 3 and 6 months after initial platelet rich plasma treatment

  3. Changes in investigator assessment of hair growth [ Time Frame: 6 months ]
    Evaluate changes in the blinded investigator's overall assessment of hair growth from baseline at 3 and 6 months

  4. Changes in subject assessment of hair growth and satisfaction [ Time Frame: 6 months ]
    Evaluate changes in the subject's overall assessment of hair growth and satisfaction from baseline at 3 and 6 months

  5. Safety and tolerability monitoring [ Time Frame: 6 months ]
    Monitor for adverse effects from and tolerability of injections



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02999737


Locations
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United States, California
Skincare and Laser Physicians of Beverly Hills
Los Angeles, California, United States, 90069
Sponsors and Collaborators
Skin Care and Laser Physicians of Beverly Hills
Eclipse Aesthetics, LLC
Investigators
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Principal Investigator: Amelia K Hausauer, MD Skincare and Laser Physicians of Beverly Hills

Publications:
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Responsible Party: Amelia K Hausauer, MD, Principal Investigator, Skin Care and Laser Physicians of Beverly Hills
ClinicalTrials.gov Identifier: NCT02999737     History of Changes
Other Study ID Numbers: AGA-2016
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Amelia K Hausauer, MD, Skin Care and Laser Physicians of Beverly Hills:
Platelet Rich Plasma
PRP
Hair loss
Alopecia
Hypotrichosis
Hair diseases

Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical