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出境医 / 临床实验 / Platelet-rich Plasma for Eyebrows

Platelet-rich Plasma for Eyebrows

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.


Condition or disease Intervention/treatment Phase
Eyebrow Hypotrichosis Device: Platelet Rich Plasma Prep System Drug: Saline Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Clinical Trial Investigating the Effect of Autologous Platelet-rich Plasma in Subjects With Mild to Moderate Eyebrow Hypotrichosis
Actual Study Start Date : September 25, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Platelet-Rich Plasma
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
intradermal injections of platelet rich plasma to the eyebrows

Placebo Comparator: Placebo (sterile saline)
Participants will receive intradermal injections of 2-3mL sterile saline to eyebrows.Three treatments will be performed 1 month apart.
Drug: Saline
intradermal injections to the eyebrows

Outcome Measures
Primary Outcome Measures :
  1. Clinical change of eyebrow hypotrichosis, as determined by scoring photographs [ Time Frame: Baseline to 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
Contacts and Locations

Contacts
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Contact: Emily Poon, PhD 312-695-6785 emily.poon@northwestern.edu
Contact: Rachael Winner 312-695-6785 rachael.winner@northwestern.edu

Locations
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United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Murad Alam    312-695-6785    m-alam@northwestern.edu   
Principal Investigator: Murad Alam, MD         
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Murad Alam Northwestern University
Tracking Information
First Submitted Date  ICMJE July 11, 2019
First Posted Date  ICMJE July 15, 2019
Last Update Posted Date April 2, 2021
Actual Study Start Date  ICMJE September 25, 2019
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2019)
Clinical change of eyebrow hypotrichosis, as determined by scoring photographs [ Time Frame: Baseline to 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Platelet-rich Plasma for Eyebrows
Official Title  ICMJE A Pilot Clinical Trial Investigating the Effect of Autologous Platelet-rich Plasma in Subjects With Mild to Moderate Eyebrow Hypotrichosis
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Eyebrow Hypotrichosis
Intervention  ICMJE
  • Device: Platelet Rich Plasma Prep System
    intradermal injections of platelet rich plasma to the eyebrows
  • Drug: Saline
    intradermal injections to the eyebrows
Study Arms  ICMJE
  • Experimental: Platelet-Rich Plasma
    Participants will receive intradermal injections of 2-3mL autologous PRP to eyebrows.Three treatments will be performed 1 month apart.
    Intervention: Device: Platelet Rich Plasma Prep System
  • Placebo Comparator: Placebo (sterile saline)
    Participants will receive intradermal injections of 2-3mL sterile saline to eyebrows.Three treatments will be performed 1 month apart.
    Intervention: Drug: Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 12, 2019)
30
Original Estimated Enrollment  ICMJE
 (submitted: July 11, 2019)
40
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Emily Poon, PhD 312-695-6785 emily.poon@northwestern.edu
Contact: Rachael Winner 312-695-6785 rachael.winner@northwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04018859
Other Study ID Numbers  ICMJE STU00207701
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Murad Alam, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Murad Alam Northwestern University
PRS Account Northwestern University
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP