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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002740-85-ES

Enrollment

Registered

2013-11-12

Start date

2014-02-11

Completion date

Unknown

Last updated

2018-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Androgenetic alopecia

Interventions

Product Name: PRP (OBTENIDO POR PRGF-ENDORET) Pharmaceutical Form: Solution for injection INN or Proposed INN: PRGF-ENDORET Other descriptive name: AUTOLOGOUS PLASMA Concentration unit: ml millilitre(

Eligibility

Sex/Gender

All

Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: Not applicable;Primary end point(s): Hair density (number of hairs per cm2);Timepoint(s) of evaluation of this end point: Basal, 1, 2 , and 3 months post-treatment	—

Secondary

Measure	Time frame
Secondary end point(s): * Hair Width (micrometers) * Anagen/telogen ratio * Terminal Hair Density * Vellous hair density;Timepoint(s) of evaluation of this end point: Basal, 1, 2 , and 3 months post-treatment	—

Countries

Spain

Contacts

Public ContactCTA

BTIBIOTECHNOLOGY INSTITUTE IMASD

virginia.cuadrado@bti-implant.es34945160653

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026