Androgenetic Alopecia
Conditions
Keywords
Platelet Rich Plasma, PRP, Hair loss, Alopecia, Hypotrichosis, Hair diseases
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.
Interventions
BIOLOGICALPlatelet 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)
BIOLOGICALPlatelet 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)
Sponsors
Eclipse Aesthetics, LLC
Skin Care and Laser Physicians of Beverly Hills
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in terminal hair counts | 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
| Measure | Time frame | Description |
|---|---|---|
| Percent change in terminal hair shaft caliber | 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 |
| Degree of hair shedding | 6 months | 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 | 6 months | 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 | 6 months | Evaluate changes in the subject's overall assessment of hair growth and satisfaction from baseline at 3 and 6 months |
| Safety and tolerability monitoring | 6 months | Monitor for adverse effects from and tolerability of injections |
Countries
United States
Outcome results
None listed