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Trial record 2 of 24 for:    prp and hair

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

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ClinicalTrials.gov Identifier: NCT02591355
Recruitment Status : Completed
First Posted : October 29, 2015
Last Update Posted : December 24, 2019
Sponsor:
Collaborator:
RegenLab USA LLC
Information provided by (Responsible Party):
Regen Lab SA

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.

Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Device: Autologous Platelet Rich Plasma Device: Saline solution injection Not Applicable

Detailed Description:
This study was designed to better assess the efficacy of PRP in hair loss, we therefore propose to study interval intralesional PRP injections for patients with androgenetic alopecia (AGA). Androgenetic alopecia is the most common form of hair loss world-wide. Although there are currently numerous treatment options for this indication including minoxidil, 5-alpha reductase inhibitors and follicular unit transplant, many of the medical treatment options have undesirable side effects, particularly in women of child bearing age. These well-documented adverse reactions include impotency, hypertrichosis, and birth defects.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Monocentric, Double-blind, Randomized, Active- and Placebo-controlled Split-scalp Study to Evaluate the Clinical Effectiveness of Platelet-rich Plasma (PRP) in the Treatment of Androgenetic Alopecia
Actual Study Start Date : September 6, 2017
Actual Primary Completion Date : November 18, 2019
Actual Study Completion Date : November 18, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Autologous Platelet Rich Plasma
Autologous Platelet Rich Plasma injection
Device: Autologous Platelet Rich Plasma
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.

Placebo Comparator: Saline
Saline solution injection
Device: Saline solution injection
Placebo is a saline solution




Primary Outcome Measures :
  1. Evaluate the changes in hair density of androgenetic alopecia [ Time Frame: 5 months ]
    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.


Secondary Outcome Measures :
  1. Evaluate the changes of hair diameter and hair shedding in androgenetic alopecia [ Time Frame: 5 months ]
    Evaluate the changes of hair diameter and hair shedding in androgenetic alopecia after 5 months treatment of Autologous Platelet Rich Plasma prepared with the RegenBCT-1 kit compared to other half of the scalp treated with saline solution.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Patients taking vitamin E supplements can participate, provided medication is interrupted 14 days before beginning of the treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02591355


Locations
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United States, California
Axis Clinical Trials
Los Angeles, California, United States, 90036
United States, New York
NYU Dermatologic Associates
New York, New York, United States, 10016
Sponsors and Collaborators
Regen Lab SA
RegenLab USA LLC
Investigators
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Principal Investigator: Jerry Shapiro, MD NYU School of Medicine, Langone Medical Center, New-York University
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Responsible Party: Regen Lab SA
ClinicalTrials.gov Identifier: NCT02591355    
Other Study ID Numbers: RL 03
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Regen Lab SA:
Platelet Rich Plasma
Hair Loss
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical