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The Effect of Platelet Rich Plasma on Non-scarring Alopecia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03689452
Recruitment Status : Completed
First Posted : September 28, 2018
Last Update Posted : June 25, 2019
Sponsor:
Collaborator:
Eclipse Aesthetics, LLC
Information provided by (Responsible Party):
Hooman Khorasani, Icahn School of Medicine at Mount Sinai

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.


Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Alopecia Device: Platelet Rich Plasma Drug: Normal saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Platelet Rich Plasma on Non-scarring Alopecia
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : June 3, 2019
Actual Study Completion Date : June 3, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control
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
Preservative-free normal saline will be used as described in arm/group description section.

Experimental: Treatment
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
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.




Primary Outcome Measures :
  1. Qualitative assessment of hair growth using photography [ Time Frame: Week 40 ]
    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.

  2. Assessment of the change in hair caliber using trichoscopy [ Time Frame: Week 40 ]
    Trichoscopy is a microscope used to assess hair. This will be used to measure hair caliber in millimeters.

  3. Assessment of the change in hair density using trichoscopy [ Time Frame: Week 40 ]
    Trichoscopy is a microscope used to assess hair. This will be used to measure hair density (number of hairs in a square centimeter of scalp).


Secondary Outcome Measures :
  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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689452


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10028
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Eclipse Aesthetics, LLC
Investigators
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Principal Investigator: Hooman Khorasani, MD Icahn School of Medicine at Mount Sinai
  Study Documents (Full-Text)

Documents provided by Hooman Khorasani, Icahn School of Medicine at Mount Sinai:
Study Protocol  [PDF] September 21, 2018

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Responsible Party: Hooman Khorasani, Clinical Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03689452    
Other Study ID Numbers: GCO 18-1714
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Raw individual participant data will not be shared with other researchers in an effort to preserve participant confidentiality.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical