The Effect of Platelet Rich Plasma on Non-scarring Alopecia

NCT ID: NCT03689452

Last Updated: 2020-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2019-06-03

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.

Conditions

Androgenetic Alopecia; Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Platelet Rich Plasma

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Normal saline

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eclipse Aesthetics, LLC

OTHER

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Hooman Khorasani

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hooman Khorasani, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

GCO 18-1714

Identifier Type: -

Identifier Source: org_study_id