Plasma Rich in Growth Factors (PRGF-Endoret)in the Treatment of Androgenetic Alopecia
|ClinicalTrials.gov Identifier: NCT01885676|
Recruitment Status : Unknown
Verified June 2013 by Biotechnology Institute IMASD.
Recruitment status was: Not yet recruiting
First Posted : June 25, 2013
Last Update Posted : June 25, 2013
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Androgenetic Alopecia||Device: PRGF-Endoret Other: Saline Solution||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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.|
|Estimated Primary Completion Date :||February 2014|
PRGF-Endoret mesotherapy micro injection.
|Placebo Comparator: Saline Solution||
Other: Saline Solution
Saline Solution mesotherapy micro injection
- Change from baseline in Hair density at three months (number of hairs per cm2) [ Time Frame: 3 months post-treatment ]Hair density (number of hairs per cm2) will be measured for each treatment group
- Hair Width (micrometers) [ Time Frame: Basal, 1, 2, and 3 months post-treatment ]Hair width will be measured for each treatment group
- Anagen/telogen ratio [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Basal,1, 2 and 3 months post-treatment ]Vellous hair will be measured for each treatment group
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01885676
|Contact: Eduardo Anitua, MD, DDS, PhD||+34 firstname.lastname@example.org|
|Clínica Eduardo Anitua.||Not yet recruiting|
|Vitoria, Alava, Spain, 01007|
|Contact: Eduardo Anitua, Medical Doctor|
|Principal Investigator: Julián Bayón, MD|
|Centro dermatológico estético||Not yet recruiting|
|Alicante, Spain, 03014|
|Contact: Rogelia Navarro, Medical Doctor 965 14 04 60 email@example.com|
|Principal Investigator: Rogelia Navarro, MD|