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.

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01885676

Enrollment

Registered

2013-06-25

Start date

2013-09-16

Completion date

2017-12-18

Last updated

2025-02-06

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

Conditions

Androgenetic Alopecia

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.

Interventions

DEVICEPRGF-Endoret

PRGF-Endoret mesotherapy micro injection.

OTHERSaline Solution

Saline Solution mesotherapy micro injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

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

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026