The Effect of Platelet Rich Plasma on Non-scarring Alopecia

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Platelet Rich Plasma on Non-scarring Alopecia

Conditions
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Androgenetic Alopecia, Alopecia

Intervention / Treatment
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* Device: Platelet Rich Plasma
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>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. | Drug: Normal saline<br>* Preservative-free normal saline will be used as described in arm/group description section.<br>|
| Experimental: Treatment<br>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. | Device: Platelet Rich Plasma<br>* Platelet Rich Plasma (PRP) is defined as an autologous concentration of human platelets that is 3 to 5 times greater than physiologic concentration of platelets in whole blood. Using the Eclipse PRP system, the participants PRP will be attained. The PRP will then be used as described in the arm/group description section.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Improvement | 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 | through study completion, 24 weeks | 
| Change in Hair Caliber Using Trichoscopy | 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. | Week 8 and 24 | 
| Change in Hair Density Using Trichoscopy | 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). | Week 8 and 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative Assessment of Hair Growth | 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. | Week 40 | 
| Qualitative Assessment of Pain Associated With the Treatment | 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. | Week 40 | 
| Qualitative Assessment of Adverse Effects Associated With the Treatment | 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 | Week 40 |