Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03048461
Other study ID # MA04222016
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date June 2019
Est. completion date December 2020

Study information

Verified date December 2021
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of autologous platelet-rich plasma (PRP) in the treatment of androgenetic alopecia. This is a randomized clinical trial to evaluate the effect of autologous platelet rich plasma in subjects with moderate androgenetic alopecia. Approximately 30 subjects will be randomized into the study. The study is designed as an 18-month study consisting of 2 phases. 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: 1. Males or females = 18 years old and =55 years old 2. Subjects are in good health as judged by the investigator. 3. Diagnosed with by a dermatologist with moderate androgenetic alopecia. 4. Subject is seeking treatment for androgenetic alopecia. 5. Subject has never previously used finasteride or minoxidil or has consistently used finasteride or minoxidil for at least 1 year. 6. 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. Other than androgenetic alopecia, evidence of another skin condition affecting the treatment area that would interfere with clinical assessments. 2. Subjects who are unwilling to avoid initiating treatment with minoxidil or finasteride for the duration of the study; or in subjects who have been treated with minoxidil or finasteride for at least 1 year, unwilling to avoid changes in the dosing regimen of these medications for the duration of the study. 3. Willing to refrain from washing hair or using hair product 24 hours before and after treatment visits 4. History of a clinically significant hematologic disorder as determined by the investigator. 5. Subjects currently receiving anticoagulant or anti-platelet therapy. 6. Subjects on daily Aspirin therapy for cardiovascular disease. 7. Subjects with chronic NSAID use, unable to wean off. 8. Subject is known to be HIV positive. 9. History of recurrent facial or labial herpes simplex infection 10. History of hypertrophic scars or keloids 11. Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia, osteogenesis imperfecta, etc. 12. Subjects who have any requirement for the use of local or systemic steroids or other immunosuppressive agent 13. Pregnant or breast feeding 14. Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations. 15. Subjects who are unable to understand the protocol or give informed consent.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Platelet Rich Plasma Prep System
intradermal injections of platelet rich plasma to an area of alopecia
Drug:
Placebo
intradermal injections to an area of alopecia

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical change of androgenetic alopecia, as determined by scoring photographs Baseline to 6 months
See also
  Status Clinical Trial Phase
Completed NCT02591355 - Evaluate the Clinical Effectiveness of RegenKit Platelet-rich Plasma (PRP) in Androgenetic Alopecia Treatment N/A
Withdrawn NCT03852992 - Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia Phase 2
Recruiting NCT06239207 - Efficacy and Safety of Exosomes Versus Platelet Rich Plasma in Patients of Androgenetic Alopecia Phase 2
Completed NCT04945226 - A Clinical Trial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of IVL3001 Phase 1/Phase 2
Completed NCT01437163 - Treatment of Androgenetic Alopecia in Males and Females N/A
Completed NCT01548066 - The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss Phase 2
Completed NCT01226459 - Clinical Trial in Females for Female Pattern Hair Loss Phase 3
Recruiting NCT06118866 - A Study to Assess the Efficacy and Safety of HMI-115 in Male Subjects With Androgenetic Alopecia Phase 2
Completed NCT06149221 - Penetration-enhanced Direct DBD Non-thermal Plasma for Hair Loss N/A
Withdrawn NCT04882969 - Thulium Laser and KeraFactor for the Treatment of Androgenetic Alopecia N/A
Completed NCT01231607 - Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia Phase 3
Completed NCT04446429 - Anti-Androgen Treatment for COVID-19 N/A
Completed NCT02729415 - Point-of-Care Adipose-derived Cells for Hair Growth N/A
Completed NCT02279823 - A Phase 2 Study to Evaluate the Safety and Efficacy of CB-03-01 Solution, a Comparator Solution and Vehicle Solution in Males With Androgenetic Alopecia Phase 2
Not yet recruiting NCT01227031 - Pharmacogenomic Study of Androgenetic Alopecia N/A
Completed NCT00981461 - Treatment of Androgenetic Alopecia in Females, 9 Beam N/A
Completed NCT01451021 - A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss Phase 2
Completed NCT00151515 - A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss Phase 3
Completed NCT03694067 - Androgenetic Alopecia and the JAK-STAT Pathway
Completed NCT03689452 - The Effect of Platelet Rich Plasma on Non-scarring Alopecia N/A