Clinical trial NCT03689452: The Effect of Platelet Rich Plasma on Non-scarring Alopecia
Official title: The Effect of Platelet Rich Plasma on Non-scarring Alopecia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Androgenetic Alopecia
Alopecia
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Eclipse Aesthetics, LLC
First posted: 2018-09-28
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Participants With Improvement
timeFrame: through study completion, 24 weeks
measure: Change in Hair Caliber Using Trichoscopy
timeFrame: Week 8 and 24
measure: Change in Hair Density Using Trichoscopy
timeFrame: Week 8 and 24
Secondary outcomes:
measure: Qualitative Assessment of Hair Growth
timeFrame: Week 40
measure: Qualitative Assessment of Pain Associated With the Treatment
timeFrame: Week 40
measure: Qualitative Assessment of Adverse Effects Associated With the Treatment
timeFrame: Week 40
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Hooman Khorasani, MD
role: PRINCIPAL_INVESTIGATOR
References: