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The Effect of Platelet Rich Plasma on Non-scarring Alopecia

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Mount Sinai Health System

Status

Completed

Conditions

Alopecia
Androgenetic Alopecia

Treatments

Device: Platelet Rich Plasma
Drug: Normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT03689452
GCO 18-1714

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups, including a placebo group

Control
Placebo Comparator group
Description:
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:
Drug: Normal saline
Treatment
Experimental group
Description:
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.
Treatment:
Device: Platelet Rich Plasma

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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