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Completed

NCT Number: NCT03689452

The Effect of Platelet Rich Plasma on Non-scarring Alopecia

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.

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Key information

Conditions

Androgenetic Alopecia Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10028, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet rich plasma

Device

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.

normal saline

Drug

Preservative-free normal saline will be used as described in arm/group description section.

Primary outcomes

  1. Number of Participants With Improvement

    Time frame: 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

  2. Change in Hair Caliber Using Trichoscopy

    Time frame: 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.

  3. Change in Hair Density Using Trichoscopy

    Time frame: 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 outcomes

  1. Qualitative Assessment of Hair Growth

    Time frame: 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.

  2. Qualitative Assessment of Pain Associated With the Treatment

    Time frame: 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.

  3. Qualitative Assessment of Adverse Effects Associated With the Treatment

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Eclipse Aesthetics, LLC

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 28, 2018
Registry last updated
Oct 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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