Platelet-rich Plasma for Eyebrows
Primary Purpose
Eyebrow Hypotrichosis
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Platelet Rich Plasma Prep System
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Eyebrow Hypotrichosis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
Sites / Locations
- Northwestern UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Platelet-Rich Plasma
Placebo (sterile saline)
Arm Description
Participants will receive intradermal injections of 2-3mL autologous PRP to eyebrows.Three treatments will be performed 1 month apart.
Participants will receive intradermal injections of 2-3mL sterile saline to eyebrows.Three treatments will be performed 1 month apart.
Outcomes
Primary Outcome Measures
Clinical change of eyebrow hypotrichosis, as determined by scoring photographs
Secondary Outcome Measures
Full Information
NCT ID
NCT04018859
First Posted
July 11, 2019
Last Updated
February 17, 2023
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT04018859
Brief Title
Platelet-rich Plasma for Eyebrows
Official Title
A Pilot Clinical Trial Investigating the Effect of Autologous Platelet-rich Plasma in Subjects With Mild to Moderate Eyebrow Hypotrichosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 25, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eyebrow Hypotrichosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Platelet-Rich Plasma
Arm Type
Experimental
Arm Description
Participants will receive intradermal injections of 2-3mL autologous PRP to eyebrows.Three treatments will be performed 1 month apart.
Arm Title
Placebo (sterile saline)
Arm Type
Placebo Comparator
Arm Description
Participants will receive intradermal injections of 2-3mL sterile saline to eyebrows.Three treatments will be performed 1 month apart.
Intervention Type
Device
Intervention Name(s)
Platelet Rich Plasma Prep System
Intervention Description
intradermal injections of platelet rich plasma to the eyebrows
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
intradermal injections to the eyebrows
Primary Outcome Measure Information:
Title
Clinical change of eyebrow hypotrichosis, as determined by scoring photographs
Time Frame
Baseline to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alejandra Onate, M.S.
Email
onate@northwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Derm CTU
Phone
312-503-5944
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murad Alam
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandra Onate, M.S.
Email
onate@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Murad Alam, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Platelet-rich Plasma for Eyebrows
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