The Effect of Platelet Rich Plasma on Non-scarring Alopecia

Androgenetic Alopecia Clinical Trial

Official title:

The Effect of Platelet Rich Plasma on Non-scarring Alopecia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03689452
• Other study ID #: GCO 18-1714
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: June 3, 2019

Study information

• Verified date: October 2020
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 3, 2019
• Est. primary completion date: June 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia

Intervention

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.

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

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Eclipse Aesthetics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Improvement	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	through study completion, 24 weeks
Primary	Change in Hair Caliber Using Trichoscopy	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.	Week 8 and 24
Primary	Change in Hair Density Using Trichoscopy	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).	Week 8 and 24
Secondary	Qualitative Assessment of Hair Growth	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.	Week 40
Secondary	Qualitative Assessment of Pain Associated With the Treatment	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.	Week 40
Secondary	Qualitative Assessment of Adverse Effects Associated With the Treatment	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	Week 40