The Effect of Platelet Rich Plasma on Non-scarring Alopecia

NCT03689452 | Completed Results FDA Device

• 1 other identifier: GCO 18-1714
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• Qualitative Assessment of Hair Growth

  Week 40

• Qualitative Assessment of Pain Associated With the Treatment

  Week 40

• Qualitative Assessment of Adverse Effects Associated With the Treatment

  Week 40

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Treatment

EXPERIMENTAL

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

Interventions

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.

Treatment

Normal saline DRUG

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

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Eclipse Aesthetics, LLC: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10028, United States

Location

MeSH Terms

Conditions

Alopecia

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Danielle P. Dubin
• Organization: Icahn School of Medicine at Mount Sinai

DPDubin121@gmail.com

212-731-3311

Study Officials

• Hooman Khorasani, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 28, 2018
• Study Start: October 1, 2018
• Primary Completion: June 3, 2019
• Study Completion: June 3, 2019
• Last Updated: October 30, 2020
• Results First Posted: October 30, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)