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

NCT ID: NCT01885676

Last Updated: 2025-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-16

Study Completion Date

2017-12-18

Brief Summary

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* 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.

Detailed Description

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Conditions

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Androgenetic Alopecia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PRGF-Endoret

Group Type EXPERIMENTAL

PRGF-Endoret

Intervention Type DEVICE

PRGF-Endoret mesotherapy micro injection.

Saline Solution

Group Type PLACEBO_COMPARATOR

Saline Solution

Intervention Type OTHER

Saline Solution mesotherapy micro injection

Interventions

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PRGF-Endoret

PRGF-Endoret mesotherapy micro injection.

Intervention Type DEVICE

Saline Solution

Saline Solution mesotherapy micro injection

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biotechnology Institute IMASD

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clínica Eduardo Anitua.

Vitoria-Gasteiz, Alava, Spain

Site Status

Centro dermatológico estético

Alicante, , Spain

Site Status

Countries

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Spain

Other Identifiers

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BTI-01D-EC/12/ALO

Identifier Type: -

Identifier Source: org_study_id

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