Plasma Rich in Growth Factors (PRGF-Endoret)in the Treatment of Androgenetic Alopecia

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by Biotechnology Institute IMASD
Sponsor:
Information provided by (Responsible Party):
Biotechnology Institute IMASD
ClinicalTrials.gov Identifier:
NCT01885676
First received: June 19, 2013
Last updated: June 24, 2013
Last verified: June 2013
  Purpose
  • Androgenetic alopecia (AGA) or common baldness is the most common cause of hair loss in both men and women and is caused by the action of androgens in genetically predisposed individuals.
  • This clinical trial was designed to evaluate the efficacy and safety of using a preparation of autologous plasma rich in growth factors (PRGF-Endoret) in the treatment of androgenetic alopecia.

Condition Intervention
Androgenetic Alopecia
Device: PRGF-Endoret
Other: Saline Solution

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Randomized, Double-blind, Placebo-controlled Clinical Trial to Obtain Preliminary Data on Efficacy and Safety in the Application of PRGF-Endoret by Mesotherapy, in the Treatment of Male and Female Androgenetic Alopecia of Over 6 Months Duration.

Resource links provided by NLM:


Further study details as provided by Biotechnology Institute IMASD:

Primary Outcome Measures:
  • Change from baseline in Hair density at three months (number of hairs per cm2) [ Time Frame: 3 months post-treatment ] [ Designated as safety issue: No ]
    Hair density (number of hairs per cm2) will be measured for each treatment group


Secondary Outcome Measures:
  • Hair Width (micrometers) [ Time Frame: Basal, 1, 2, and 3 months post-treatment ] [ Designated as safety issue: No ]
    Hair width will be measured for each treatment group

  • Anagen/telogen ratio [ Time Frame: Basal, 1, 2, and 3 months post-treatment ] [ Designated as safety issue: No ]
    Hair cycle has different phases. Two of the most important are anagen (active growth phase of hair follicles) and telogen (resting phase of the hair follicle). This secondary outcome measure allows to measure the efficacy of the PRGF-Endoret treatment.

  • Terminal Hair Density [ Time Frame: Before each one of the treatments and 1, 2 and 3 months post-treatment. ] [ Designated as safety issue: No ]
    Terminal hair density will be established for each one of the treatments

  • Vellous hair density [ Time Frame: Basal,1, 2 and 3 months post-treatment ] [ Designated as safety issue: No ]
    Vellous hair will be measured for each treatment group


Estimated Enrollment: 24
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRGF-Endoret Device: PRGF-Endoret
PRGF-Endoret mesotherapy micro injection.
Placebo Comparator: Saline Solution Other: Saline Solution
Saline Solution mesotherapy micro injection

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Androgenetic alopecia according to the following scales:
  • Men: Hamilton/Norwood Scale: grades II-VI
  • Women: Ludwig Scale grades I-II.
  • Possibility of follow-up during the study

Exclusion Criteria:

  • No androgenetic alopecia
  • Telogen and anagen effluvium
  • Active inflammation or infection in the intervention area
  • Presence of active systemic infections.
  • Background of cancerous or precancerous lesions.
  • Background of connective or rheumatic diseases.
  • Suffering from any serious blood disorders.
  • To have undergone treatments for alopecia in the previous 6 months.
  • Previous hair implants
  • Intake of drugs that affect hair loss.
  • Be undergoing immunosuppressive therapy and/or anticoagulants.
  • Known intolerance to mesotherapy.
  • Taking contraceptives containing cyproterone acetate.
  • Pregnancy
  • In general, any limitations that would prevent the proper application of both treatments and the right monitoring of the efficacy variables.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01885676

Contacts
Contact: Eduardo Anitua, MD, DDS, PhD +34 945160650 eduardoanitua@eduardoanitua.com

Locations
Spain
Clínica Eduardo Anitua. Not yet recruiting
Vitoria, Alava, Spain, 01007
Contact: Eduardo Anitua, Medical Doctor         
Principal Investigator: Julián Bayón, MD         
Centro dermatológico estético Not yet recruiting
Alicante, Spain, 03014
Contact: Rogelia Navarro, Medical Doctor    965 14 04 60    alopecia.ccdermatologico@gmail.com   
Principal Investigator: Rogelia Navarro, MD         
Sponsors and Collaborators
Biotechnology Institute IMASD
  More Information

No publications provided

Responsible Party: Biotechnology Institute IMASD
ClinicalTrials.gov Identifier: NCT01885676     History of Changes
Other Study ID Numbers: BTI-01D-EC/12/ALO
Study First Received: June 19, 2013
Last Updated: June 24, 2013
Health Authority: Spain: Ethics Committee

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014