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

NCT02999737 | Unknown Phase 4

• 1 other identifier: AGA-2016
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Androgenetic Alopecia

Keywords

Platelet Rich Plasma; PRP; Hair loss; Alopecia; Hypotrichosis; Hair diseases

Outcome Measures

Primary Outcomes (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

  6 months

Secondary Outcomes (5)

• Percent change in terminal hair shaft caliber

  6 months

• Degree of hair shedding

  6 months

• Changes in investigator assessment of hair growth

  6 months

• Changes in subject assessment of hair growth and satisfaction

  6 months

• Safety and tolerability monitoring

  6 months

Study Arms (2)

Platelet Rich Plasma for 4 sessions

OTHER

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

Biological: Platelet Rich Plasma for 4 sessions

Platelet rich plasma for 2 sessions

OTHER

Autologous Platelet Rich Plasma injected in the scalp every 3 months

Biological: Platelet rich plasma for 2 sessions

Interventions

Platelet Rich Plasma for 4 sessions BIOLOGICAL

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 4 sessions

Platelet rich plasma for 2 sessions BIOLOGICAL

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

Platelet rich plasma for 2 sessions

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Skin Care and Laser Physicians of Beverly Hills: lead
• Eclipse Aesthetics, LLC: collaborator

Study Sites (1)

Skincare and Laser Physicians of Beverly Hills

Los Angeles, California, 90069, United States

Location

Related Publications (5)

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

  PMID: 9748188 BACKGROUND

• 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.

  PMID: 1607410 BACKGROUND

• 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.

  PMID: 25722600 BACKGROUND

• 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.

  PMID: 26400925 BACKGROUND

• 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.

  PMID: 27035501 BACKGROUND

MeSH Terms

Conditions

Alopecia; Hypotrichosis; Hair Diseases

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Amelia K Hausauer, MD

  Skincare and Laser Physicians of Beverly Hills

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: December 21, 2016
• Study Start: November 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: January 12, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)