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

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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.

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.
    



Study Type

Interventional


Primary Outcome

Change from baseline in Hair density at three months (number of hairs per cm2)

Secondary Outcome

 Hair Width (micrometers)

Condition

Androgenetic Alopecia

Intervention

PRGF-Endoret

Study Arms / Comparison Groups

 PRGF-Endoret
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

24



Primary Completion Date

February 2014

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.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

, +34 945160650, [email protected]

Location Countries

Spain

Location Countries

Spain

Administrative Informations


NCT ID

NCT01885676

Organization ID

BTI-01D-EC/12/ALO


Responsible Party

Sponsor

Study Sponsor

Biotechnology Institute IMASD


Study Sponsor

, , 


Verification Date

June 2013