N/A N=30 Randomized Double-blind Treatment

The Effect of Platelet Rich Plasma on Non-scarring Alopecia

Androgenetic Alopecia · Alopecia

Bottom Line

View on ClinicalTrials.gov: NCT03689452 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2020

Primary outcome: Primary: Number of Participants With Improvement — 8; 1 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Platelet Rich Plasma (Device); Normal saline (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Icahn School of Medicine at Mount Sinai
Primary completion: Jun 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Improvement	8; 1	—
PRIMARY Change in Hair Caliber Using Trichoscopy	0.0043; -0.0034; 0.0053; -0.0060	—
PRIMARY Change in Hair Density Using Trichoscopy	71.1; -26.7; 105.9; -52.4	—
SECONDARY Qualitative Assessment of Hair Growth	—	—
SECONDARY Qualitative Assessment of Pain Associated With the Treatment	—	—
SECONDARY Qualitative Assessment of Adverse Effects Associated With the Treatment	—	—

Summary

The purpose of this study is to evaluate the clinical efficacy of platelet rich plasma (PRP) injections for non-scaring alopecia in women. A randomized, placebo-controlled clinical trial will be performed where patients with non-scarring alopecia will either receive injections of their own PRP or injections of normal saline (placebo). Patients in the treatment group (Group A) will have a small amount of their own blood drawn and have their PRP injected into their scalp four times. The injections will be given at weeks zero, four, eight, and twenty four. The placebo group (Group B) will be given the same schedule but will receive sham injections only and will not have any blood drawn. Both groups will have clinical data collected at all visits, including a screening visit before enrollment and a final assessment visit at week 40, for a total of 6 study visits per patient. Data collection will include representative photographs of the scalp and measurements of hair thickness. The results from the two groups will then be compared. In summary, all study participants will have a screening visit before enrollment, four study visits for sub-dermal scalp injections, and one final assessment visit at week 40.

Eligibility Criteria

Inclusion Criteria

Must understand and voluntarily sign an informed consent form
Must be female between the ages of 18 and 65 years at the time of consent
Must be able to adhere to the study visit schedule and other protocol requirements
Documented platelet count above 150, 000 platelets per microliter within 6 months prior to enrollment

Exclusion Criteria

Previous or current use in the last 1 year of finasteride, minoxidil topical or oral, or spironolactone
A diagnosis of non-androgenic alopecia (i.e: another diagnosis for the alopecia )
No Baseline ferritin, thyroid-stimulating hormone, platelet count, and a negative urine pregnancy test in any pre-menopausal female in past 12 months.
Active skin disease (Psoriasis or severe seborrheic dermatitis) of the scalp
Scalp infection
Severe active blood infection
Cuts or abrasions on the scalp
History of surgical hair restoration
Current or recent malignancy
History of systemic chemotherapy or radiation
History of thyroid dysfunction
History of autoimmune disorder (specifically Graves disease, hashimoto thyroiditis, or systemic lupus erythematosus)
Tendency to develop keloids
Nonsteroidal anti-inflammatory or Vitamin E discontinued in the last 7-14 days
Platelet dysfunction syndrome
Thrombocytopenia less than 150,000
Diagnosis of hypofibrinogenemia
Anticipated pregnancy or trying to become pregnant in the next 2 years

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03689452). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.