Overview

Platelet-rich Plasma for Eyebrows

Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Northwestern University
Criteria
Inclusion Criteria:

1. Males or females 18-85 years old.

2. Subjects are in good health as judged by the investigator.

3. Patients with mild to moderate eyebrow hypotrichosis (modified GEyA grades of 3 and 4
at the time of screening, see Appendix A).

4. 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).

5. 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

Exclusion Criteria:

1. Patients with uncontrolled systemic disease (including alopecia areata or any other
form of alopecia) which could inhibit hair growth

2. 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.

3. 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.

4. Known disease, infection, or abnormality in the treatment area or hair shaft

5. Patients with tattoos, scars, hyperpigmentation, or other features which could prevent
accurate evaluation of hair growth in the eyebrow area.

6. Evidence of another skin condition affecting the treatment area that would interfere
with clinical assessments

7. Unwilling to refrain from washing face or using face care products 24 hours before and
after treatment visits

8. History of a clinically significant hematologic disorder as determined by the
investigator.

9. Subjects currently receiving anticoagulant or anti-platelet therapy.

10. Subject is known to be HIV positive.

11. Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia,
osteogenesis imperfecta, etc.

12. Pregnant or breast feeding

13. Uncooperative patients or patients with neurological disorders who are incapable of
following directions or who are predictably unwilling to return for follow-up
examinations.

14. Subjects who are unable to understand the protocol or give informed consent (including
non-English speaking patients).