Platelet-rich Plasma for Eyebrows

NCT ID: NCT04018859

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-25
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Platelet-Rich Plasma

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

Group Type: EXPERIMENTAL

Platelet Rich Plasma Prep System

Intervention Type: DEVICE

intradermal injections of platelet rich plasma to the eyebrows

Placebo (sterile saline)

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

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

intradermal injections to the eyebrows

Interventions

Platelet Rich Plasma Prep System

intradermal injections of platelet rich plasma to the eyebrows

Intervention Type: DEVICE

Saline

intradermal injections to the eyebrows

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Murad Alam

Professor of Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Murad Alam

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00207701

Identifier Type: -

Identifier Source: org_study_id