The Effect of Platelet Rich Plasma on Non-scarring Alopecia

Not Applicable

Completed

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Control	Normal saline	15 participants will receive 3 mL of preservative free normal saline injected in a standardized pattern with each injection 1-2 cm apart with 0.2 to 0.3 mL per injection. Participants will receive this treatment at weeks 0, 4, 8, and 24.
Treatment	Platelet Rich Plasma	15 participants will receive 3-6 mL of platelet rich plasma injected in a standardized pattern with each injection 1-2 cm apart with 0.2 to 0.3 mL per injection. Participants will receive this treatment at weeks 0, 4, 8, and 24.

Primary Outcome Measures

Name	Time	Method
Change in Hair Caliber Using Trichoscopy	Week 8 and 24	Change in Hair Caliber using trichoscopy as compared to baseline. Trichoscopy is a microscope used to assess hair. This was used to measure hair caliber in millimeters.
Number of Participants With Improvement	through study completion, 24 weeks	Number of participants with improvement by qualitative global assessment of hair growth using photography. Photographs of the scalp with standard digital camera used to assess overall change in hair appearance on a macroscopic level. This will be done using the Ludwig Classification system. I is appreciable thinning of the crown hair, II is increased territorial involvement and scalp visibility, and III is total denudation of the areas involved in I and II
Change in Hair Density Using Trichoscopy	Week 8 and 24	Change in Hair Density using trichoscopy as compared to baseline. Trichoscopy is a microscope used to assess hair. This was used to measure hair density (number of hairs in a square centimeter of scalp).

Secondary Outcome Measures

Name	Time	Method
Qualitative Assessment of Hair Growth	Week 40	Surveys will be distributed to assess participant opinion regarding overall hair growth after treatment. This will be done using a hair growth scale in which 0 is no improvement in hair growth and 10 is greatly improved hair growth.
Qualitative Assessment of Pain Associated With the Treatment	Week 40	Surveys will be distributed to assess participant opinion regarding the degree of pain associated with the treatment. This will be done using a pain scale of 0 to 10 with 0 being no pain and 10 being worst pain ever.
Qualitative Assessment of Adverse Effects Associated With the Treatment	Week 40	Questionnaires will be distributed to assess participant opinion regarding adverse effects associated with the treatment. This will be assessed via a multiple choice questionnaire with the following options: i. Headache ii. Scalp tightness iii. Swelling iv. Redness v. Post-injection bleeding vi. Infection vii. Nerve damage viii. Other: ____________________ ix. None

Locations (1): Icahn School of Medicine at Mount Sinai
🇺🇸
New York, New York, United States