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

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.

• 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.

Study Overview

• Status: Unknown
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Device: PRGF-Endoret; Other: Saline Solution

• Study Type: Interventional
• Enrollment: 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eduardo Anitua, MD, DDS, PhD; Phone Number: +34 945160650; Email: eduardoanitua@eduardoanitua.com

Study Locations

• Spain
  • Alicante, Spain, 03014
    • Centro dermatológico estético
    • Contact: Rogelia Navarro, Medical Doctor; Phone Number: 965 14 04 60; Email: alopecia.ccdermatologico@gmail.com
    • Principal Investigator: Rogelia Navarro, MD
  • Alava
    • Vitoria, Alava, Spain, 01007
      • Clínica Eduardo Anitua.
      • Contact: Eduardo Anitua, Medical Doctor
      • Principal Investigator: Julián Bayón, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Saline Solution	Other: Saline Solution; Saline Solution mesotherapy micro injection
Experimental: PRGF-Endoret	Device: PRGF-Endoret; PRGF-Endoret mesotherapy micro injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Hair density at three months (number of hairs per cm2)	Hair density (number of hairs per cm2) will be measured for each treatment group	3 months post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hair Width (micrometers)	Hair width will be measured for each treatment group	Basal, 1, 2, and 3 months post-treatment
Anagen/telogen ratio	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.	Basal, 1, 2, and 3 months post-treatment
Terminal Hair Density	Terminal hair density will be established for each one of the treatments	Before each one of the treatments and 1, 2 and 3 months post-treatment.
Vellous hair density	Vellous hair will be measured for each treatment group	Basal,1, 2 and 3 months post-treatment

Collaborators and Investigators

• Sponsor: Biotechnology Institute IMASD

Study record dates

Study Major Dates

• Primary Completion (Anticipated): February 1, 2014

Study Registration Dates

• First Submitted: June 19, 2013
• First Submitted That Met QC Criteria: June 24, 2013
• First Posted (Estimate): June 25, 2013

Study Record Updates

• Last Update Posted (Estimate): June 25, 2013
• Last Update Submitted That Met QC Criteria: June 24, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: BTI-01D-EC/12/ALO