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

Not Applicable

Withdrawn

• Conditions: Androgenetic Alopecia
• Interventions: Device: PRGF-Endoret; Other: Saline Solution

• Registration Number: NCT01885676
• Lead Sponsor: Biotechnology Institute IMASD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-19
• Study First Submitted QC: 2013-06-24
• Study First Posted: 2013-06-25
• Study Start: 2013-09-16
• Primary Completion: 2015-09
• Study Completion: 2017-12-18
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRGF-Endoret	PRGF-Endoret	-
Saline Solution	Saline Solution	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Clínica Eduardo Anitua.; 🇪🇸 Vitoria, Alava, Spain

Centro dermatológico estético; 🇪🇸 Alicante, Spain