The Effect of Platelet-rich Plasma in Subjects With Androgenetic Alopecia

NCT03048461 | Withdrawn Phase 2 FDA Device

• 1 other identifier: MA04222016
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (1)

• Clinical change of androgenetic alopecia, as determined by scoring photographs

  Baseline to 6 months

Study Arms (2)

Platelet Rich Plasma

EXPERIMENTAL

Participants will receive intradermal injections autologous PRP to an area (100cm2) of alopecia on the scalp.Two treatments will be performed 3 months apart

Device: Platelet Rich Plasma Prep System

Placebo (sterile saline)

PLACEBO COMPARATOR

Participants will receive intradermal injections of sterile normal saline to an area (100cm2) of alopecia on the scalp. Two treatments will be performed 3 months apart

Device: Platelet Rich Plasma Prep System; Drug: Placebo

Interventions

Platelet Rich Plasma Prep System DEVICE

intradermal injections of platelet rich plasma to an area of alopecia

Placebo (sterile saline); Platelet Rich Plasma

Placebo DRUG

intradermal injections to an area of alopecia

Placebo (sterile saline)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Males or females ≥ 18 years old and ≤55 years old
• Subjects are in good health as judged by the investigator.
• Diagnosed with by a dermatologist with moderate androgenetic alopecia.
• Subject is seeking treatment for androgenetic alopecia.
• Subject has never previously used finasteride or minoxidil or has consistently used finasteride or minoxidil for at least 1 year.
• 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.

You may not qualify if:

• Other than androgenetic alopecia, evidence of another skin condition affecting the treatment area that would interfere with clinical assessments.
• 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.
• Willing to refrain from washing hair or using hair product 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.
• Subjects on daily Aspirin therapy for cardiovascular disease.
• Subjects with chronic NSAID use, unable to wean off.
• Subject is known to be HIV positive.
• History of recurrent facial or labial herpes simplex infection
• History of hypertrophic scars or keloids
• Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia, osteogenesis imperfecta, etc.
• Subjects who have any requirement for the use of local or systemic steroids or other immunosuppressive agent
• 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.

Sponsors & Collaborators

• Northwestern University: lead

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 9, 2017
• Study Start: June 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 23, 2021

Record last verified: 2021-12