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

Study Overview
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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.

Official Title
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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.

Conditions
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Androgenetic Alopecia

Intervention / Treatment
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* Device: PRGF-Endoret
* Other: Saline Solution


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRGF-Endoret<br> | Device: PRGF-Endoret<br>* PRGF-Endoret mesotherapy micro injection.<br>|
| Placebo Comparator: Saline Solution<br> | Other: Saline Solution<br>* Saline Solution mesotherapy micro injection<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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