Evaluate the Clinical Effectiveness of RegenKit Platelet-rich Plasma (PRP) in Androgenetic Alopecia Treatment

NCT02591355 | Completed FDA Device

• 1 other identifier: RL 03
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

Platelet rich plasma (PRP) therapy is a novel therapeutic modality that has seen broad applications for a number of medical indications including those in orthopedics, dentistry, and dermatology. In dermatology, its uses have included treatment of chronic wounds and facial rejuvenation. More recently, anecdotal reports have suggested some efficacy in the treatment of hair loss, but to the best of our knowledge, there has been only one published case series documenting its use for this indication.

Conditions

Androgenetic Alopecia

Keywords

Platelet Rich Plasma; Hair Loss

Outcome Measures

Primary Outcomes (1)

• Evaluate the changes in hair density of androgenetic alopecia

  Evaluate split scalp changes in hair density of androgenetic alopecia after 5 month treatment of Autologous Platelet Rich Plasma prepared with the RegenBCT-1 kit compared to other half of the scalp treated with saline solution.

  5 months

Secondary Outcomes (1)

• Evaluate the changes of hair diameter and hair shedding in androgenetic alopecia

  5 months

Study Arms (2)

Autologous Platelet Rich Plasma

EXPERIMENTAL

Autologous Platelet Rich Plasma injection

Device: Autologous Platelet Rich Plasma

Saline

PLACEBO COMPARATOR

Saline solution injection

Device: Saline solution injection

Interventions

Autologous Platelet Rich Plasma DEVICE

Autologous Platelet Rich Plasma a novel therapeutic modality used in numerous applications. In dermatology, its uses have included treatment of chronic wounds and facial rejuvenation. More recently, anecdotal reports have suggested some efficacy in the treatment of hair loss.

Autologous Platelet Rich Plasma

Saline solution injection DEVICE

Placebo is a saline solution

Saline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women, age 18-60 with AGA
• Completed informed consent form
• Ludwig stage 1-2 for women
• Norwood Hamilton Stage 3 to 5 for men

You may not qualify if:

• Pregnancy or breastfeeding
• Younger than 18 years
• Uses of minoxidil and/or 5-alpha reductase inhibitors (such as finasteride or dutasteride) within 3 months of enrolling in the study
• History of hair transplantation
• Use of any cosmetic product aimed at improving or correcting the signs of hair loss within 2 weeks prior to screening
• Facial cancer (squamous and basal cell carcinoma, melanoma)
• Hereditary or acquired hematologic/coagulation disorders such as: platelet dysfunction syndrome, critical thrombocytopenia, hypofibrinogenemia, impaired coagulation, drepanocytosis (sickle cell anemia).
• Hemodynamic instability
• Acute infection
• Auto-immune disease such as Hashimoto, rheumatoid arthritis, or lupus (exception: vitiligo and alopecia areata)
• Malignancy with or without metastatic disease
• Chemotherapy
• Dermatological diseases affecting the face (e.g. porphyria)
• Anticoagulant therapy
• Patients taking Aspirin or other NSAIDs (Nonsteroidal anti-inflammatory drugs) such as Nurofen, Voltaren, Diclofenac or Naproxen can participate, provided medication is interrupted 7 days before beginning of the treatment

Sponsors & Collaborators

• Regen Lab SA: lead
• RegenLab USA LLC: collaborator

Study Sites (2)

Axis Clinical Trials

Los Angeles, California, 90036, United States

Location

NYU Dermatologic Associates

New York, New York, 10016, United States

Location

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

• Jerry Shapiro, MD

  NYU School of Medicine, Langone Medical Center, New-York University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: October 29, 2015
• Study Start: September 6, 2017
• Primary Completion: November 18, 2019
• Study Completion: November 18, 2019
• Last Updated: December 24, 2019

Record last verified: 2019-12

Locations

US (2)