search
Back to results

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

Primary Purpose

Androgenetic Alopecia

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
PRGF-Endoret
Saline Solution
Sponsored by
Biotechnology Institute IMASD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Androgenetic Alopecia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clínica Eduardo Anitua.
  • Centro dermatológico estético

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PRGF-Endoret

Saline Solution

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hair Width (micrometers)
Hair width will be measured for each treatment group
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.
Terminal Hair Density
Terminal hair density will be established for each one of the treatments
Vellous hair density
Vellous hair will be measured for each treatment group

Full Information

First Posted
June 19, 2013
Last Updated
June 24, 2013
Sponsor
Biotechnology Institute IMASD
search

1. Study Identification

Unique Protocol Identification Number
NCT01885676
Brief Title
Plasma Rich in Growth Factors (PRGF-Endoret)in the Treatment of Androgenetic Alopecia
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotechnology Institute IMASD

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (false)

8. Arms, Groups, and Interventions

Arm Title
PRGF-Endoret
Arm Type
Experimental
Arm Title
Saline Solution
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
PRGF-Endoret
Intervention Description
PRGF-Endoret mesotherapy micro injection.
Intervention Type
Other
Intervention Name(s)
Saline Solution
Intervention Description
Saline Solution mesotherapy micro injection
Primary Outcome Measure Information:
Title
Change from baseline in Hair density at three months (number of hairs per cm2)
Description
Hair density (number of hairs per cm2) will be measured for each treatment group
Time Frame
3 months post-treatment
Secondary Outcome Measure Information:
Title
Hair Width (micrometers)
Description
Hair width will be measured for each treatment group
Time Frame
Basal, 1, 2, and 3 months post-treatment
Title
Anagen/telogen ratio
Description
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.
Time Frame
Basal, 1, 2, and 3 months post-treatment
Title
Terminal Hair Density
Description
Terminal hair density will be established for each one of the treatments
Time Frame
Before each one of the treatments and 1, 2 and 3 months post-treatment.
Title
Vellous hair density
Description
Vellous hair will be measured for each treatment group
Time Frame
Basal,1, 2 and 3 months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eduardo Anitua, MD, DDS, PhD
Phone
+34 945160650
Email
eduardoanitua@eduardoanitua.com
Facility Information:
Facility Name
Clínica Eduardo Anitua.
City
Vitoria
State/Province
Alava
ZIP/Postal Code
01007
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Anitua, Medical Doctor
First Name & Middle Initial & Last Name & Degree
Julián Bayón, MD
Facility Name
Centro dermatológico estético
City
Alicante
ZIP/Postal Code
03014
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rogelia Navarro, Medical Doctor
Phone
965 14 04 60
Email
alopecia.ccdermatologico@gmail.com
First Name & Middle Initial & Last Name & Degree
Rogelia Navarro, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs