Platelet-rich Plasma for Eyebrows

NCT04018859 | Active Not Recruiting Phase 2 FDA Device

• 1 other identifier: STU00207701
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of autologous platelet-rich plasma (PRP) in the treatment of mild to moderate eyebrow hypotrichosis. This is a randomized clinical trial to evaluate the effect of autologous platelet rich plasma in subjects with mild to moderate eyebrow hypotrichosis. Approximately 40 subjects will be randomized to receive platelet-rich plasma (PRP) or saline injections. The study is designed as an 9-month study. This study was a pilot study designed to determine feasibility of this procedure. Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.

Conditions

Eyebrow Hypotrichosis

Outcome Measures

Primary Outcomes (1)

• Clinical change of eyebrow hypotrichosis, as determined by scoring photographs

  Baseline to 6 months

Study Arms (2)

Platelet-Rich Plasma

EXPERIMENTAL

Participants will receive intradermal injections of 2-3mL autologous PRP to eyebrows.Three treatments will be performed 1 month apart.

Device: Platelet Rich Plasma Prep System

Placebo (sterile saline)

PLACEBO COMPARATOR

Participants will receive intradermal injections of 2-3mL sterile saline to eyebrows.Three treatments will be performed 1 month apart.

Drug: Saline

Interventions

Platelet Rich Plasma Prep System DEVICE

intradermal injections of platelet rich plasma to the eyebrows

Platelet-Rich Plasma

Saline DRUG

intradermal injections to the eyebrows

Placebo (sterile saline)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females 18-85 years old.
• Subjects are in good health as judged by the investigator.
• Patients with mild to moderate eyebrow hypotrichosis (modified GEyA grades of 3 and 4 at the time of screening, see Appendix A).
• Those who have less eyebrows and therefore, desire to enhance eyebrows (modified GEyA grades of 3 and 4 at the time of screening, see Appendix A).
• Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator

You may not qualify if:

• Patients with uncontrolled systemic disease (including alopecia areata or any other form of alopecia) which could inhibit hair growth
• Patients with thrombocytopenia, platelet dysfunction, hypofibrinogenemia, anemia, cancer, active infections with Pseudomonas, Klebsiella, or Enterococcus, history of trichotillomania, thyroid diseases, eye diseases, atopic dermatitis, seborrheic dermatitis, lupus erythematosus, scleroderma, leprosy, or syphilis.
• Patients who have started used agents that may affect eyebrow hair growth (e.g. minoxidil or bimatoprost) within 6 months of screening. Patients who have been using agents that may affect eyebrow hair growth for at least 12 months may be included if the patient agrees to continue their current dosing regimen for the duration of the study.
• Known disease, infection, or abnormality in the treatment area or hair shaft
• Patients with tattoos, scars, hyperpigmentation, or other features which could prevent accurate evaluation of hair growth in the eyebrow area.
• Evidence of another skin condition affecting the treatment area that would interfere with clinical assessments
• Unwilling to refrain from washing face or using face care products 24 hours before and after treatment visits
• History of a clinically significant hematologic disorder as determined by the investigator.
• Subjects currently receiving anticoagulant or anti-platelet therapy.
• Subject is known to be HIV positive.
• Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia, osteogenesis imperfecta, etc.
• Pregnant or breast feeding
• Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
• Subjects who are unable to understand the protocol or give informed consent (including non-English speaking patients).

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Murad Alam

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 15, 2019
• Study Start: September 25, 2019
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)