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

Androgenetic Alopecia Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01885676
• Other study ID #: BTI-01D-EC/12/ALO
• Status: Not yet recruiting
• Phase: N/A
• First received: June 19, 2013
• Last updated: June 24, 2013

Study information

• Verified date: June 2013
• Source: Biotechnology Institute IMASD
• Contact: Eduardo Anitua, MD, DDS, PhD
• Phone: +34 945160650
• Email: eduardoanitua[@]eduardoanitua.com
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia

Intervention

Device:
• PRGF-Endoret
PRGF-Endoret mesotherapy micro injection.

Other:
• Saline Solution
Saline Solution mesotherapy micro injection

Locations

Country	Name	City	State
Spain	Centro dermatológico estético	Alicante
Spain	Clínica Eduardo Anitua.	Vitoria	Alava

Sponsors (1)

Lead Sponsor	Collaborator
Biotechnology Institute IMASD

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Hair Width (micrometers)	Hair width will be measured for each treatment group	Basal, 1, 2, and 3 months post-treatment	No
Secondary	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	No
Secondary	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.	No
Secondary	Vellous hair density	Vellous hair will be measured for each treatment group	Basal,1, 2 and 3 months post-treatment	No