Brief Title
Plasma Rich in Growth Factors (PRGF-Endoret)in the Treatment of Androgenetic Alopecia
Official Title
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.
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.
Study Type
Interventional
Primary Outcome
Change from baseline in Hair density at three months (number of hairs per cm2)
Secondary Outcome
Hair Width (micrometers)
Condition
Androgenetic Alopecia
Intervention
PRGF-Endoret
Study Arms / Comparison Groups
PRGF-Endoret
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
24
Primary Completion Date
February 2014
Eligibility 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 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.
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
, +34 945160650, [email protected]
Location Countries
Spain
Location Countries
Spain
Administrative Informations
NCT ID
NCT01885676
Organization ID
BTI-01D-EC/12/ALO
Responsible Party
Sponsor
Study Sponsor
Biotechnology Institute IMASD
Study Sponsor
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Verification Date
June 2013