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

Primary Purpose

Androgenetic Alopecia

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Platelet Rich Plasma for 4 sessions
Platelet rich plasma for 2 sessions
Sponsored by
Skin Care and Laser Physicians of Beverly Hills
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Androgenetic Alopecia focused on measuring Platelet Rich Plasma, PRP, Hair loss, Alopecia, Hypotrichosis, Hair diseases

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Skincare and Laser Physicians of Beverly Hills

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Platelet Rich Plasma for 4 sessions

Platelet rich plasma for 2 sessions

Arm Description

Autologous Platelet Rich Plasma injected in the scalp monthly x 3 then every 3 months x 1

Autologous Platelet Rich Plasma injected in the scalp every 3 months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Degree of hair shedding
Evaluate the degree of hair shedding from baseline at 3 and 6 months after initial platelet rich plasma treatment
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
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
Safety and tolerability monitoring
Monitor for adverse effects from and tolerability of injections

Full Information

First Posted
December 19, 2016
Last Updated
January 10, 2017
Sponsor
Skin Care and Laser Physicians of Beverly Hills
Collaborators
Eclipse Aesthetics, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02999737
Brief Title
Comparing Different Platelet Rich Plasma (PRP) Treatment Regimens for Management of Androgenic Alopecia
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 Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Skin Care and Laser Physicians of Beverly Hills
Collaborators
Eclipse Aesthetics, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia
Keywords
Platelet Rich Plasma, PRP, Hair loss, Alopecia, Hypotrichosis, Hair diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Platelet Rich Plasma for 4 sessions
Arm Type
Other
Arm Description
Autologous Platelet Rich Plasma injected in the scalp monthly x 3 then every 3 months x 1
Arm Title
Platelet rich plasma for 2 sessions
Arm Type
Other
Arm Description
Autologous Platelet Rich Plasma injected in the scalp every 3 months
Intervention Type
Biological
Intervention Name(s)
Platelet Rich Plasma for 4 sessions
Intervention Description
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)
Intervention Type
Biological
Intervention Name(s)
Platelet rich plasma for 2 sessions
Intervention Description
Injection of autologous platelet rich plasma into areas of alopecia on the scalp every 3 months x 2 sessions (total 2 sessions)
Primary Outcome Measure Information:
Title
Percent change in terminal hair counts
Description
Evaluate the mean change in terminal hair counts (hairs/cm2) from baseline at 3 and 6 months after initial platelet rich plasma treatment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percent change in terminal hair shaft caliber
Description
Evaluate the mean change in terminal hair shaft caliber (microns) from baseline at 3 and 6 months after initial platelet rich plasma treatment
Time Frame
6 months
Title
Degree of hair shedding
Description
Evaluate the degree of hair shedding from baseline at 3 and 6 months after initial platelet rich plasma treatment
Time Frame
6 months
Title
Changes in investigator assessment of hair growth
Description
Evaluate changes in the blinded investigator's overall assessment of hair growth from baseline at 3 and 6 months
Time Frame
6 months
Title
Changes in subject assessment of hair growth and satisfaction
Description
Evaluate changes in the subject's overall assessment of hair growth and satisfaction from baseline at 3 and 6 months
Time Frame
6 months
Title
Safety and tolerability monitoring
Description
Monitor for adverse effects from and tolerability of injections
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amelia K Hausauer, MD
Organizational Affiliation
Skincare and Laser Physicians of Beverly Hills
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skincare and Laser Physicians of Beverly Hills
City
Los Angeles
State/Province
California
ZIP/Postal Code
90069
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9748188
Citation
Sinclair R. Male pattern androgenetic alopecia. BMJ. 1998 Sep 26;317(7162):865-9. doi: 10.1136/bmj.317.7162.865. No abstract available.
Results Reference
background
PubMed Identifier
1607410
Citation
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.
Results Reference
background
PubMed Identifier
25722600
Citation
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.
Results Reference
background
PubMed Identifier
26400925
Citation
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.
Results Reference
background
PubMed Identifier
27035501
Citation
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.
Results Reference
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Comparing Different Platelet Rich Plasma (PRP) Treatment Regimens for Management of Androgenic Alopecia

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