Study to Assess Efficacy of Platelet-Rich Plasma in Androgenetic Alopecia (PRP)
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|ClinicalTrials.gov Identifier: NCT02393040|
Recruitment Status : Unknown
Verified March 2015 by Rubina Alves, Universitat Internacional de Catalunya.
Recruitment status was: Active, not recruiting
First Posted : March 19, 2015
Last Update Posted : March 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Androgenetic Alopecia Alopecia Hair Loss||Other: PRP/Saline||Not Applicable|
Androgenetic alopecia (AGA) is a non-scarring patterned alopecia, multifactorial and a genetic determined skin condition. This pathology is one of the most common forms of progressive hair loss. It's an increasingly frequent complaint of dermatology clinic patients and has a high impact psychologically.
The onset of AGA is gradual and when this pathology progresses, the anagen phase shortens and the telogen phase remains constant. As a result, more hairs are in the telogen phase, and the patient may notice an increase in hair shedding. This area varies from patient to patient and is usually most marked at the vertex in men while women with androgenetic alopecia generally lose hair diffusely over the crown. The incidence and prevalence of AGA increases with age.
Topical minoxidil and oral finasteride are the gold standard therapies for AGA and the only two drugs currently that have US Food and Drug Administration (FDA)-approved indications for the treatment of androgenetic alopecia. Minoxidil and finasteride are known to be effective medical treatments in AGA, especially during the initial grades.
PRP is a plasma concentrate reaped from the patient's whole blood that comprises predominantly platelets. Numerous growth factors (GFs) are present within platelet α granules. Some of the most important of these include platelet-derived growth factor (PDGF), transforming growth factor-beta (TGF-β), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), and insulin-like growth factor (IGF). This GFs stimulate cell proliferation and differentiation.
PRP was identified as having a beneficial effect on bone grafting with applications in oral and maxillofacial surgery, orthopedic and cardiac surgery. More recently, increasing interest is seen in the application of PRP in dermatology, for example, tissue regeneration, wound healing such and fat grafting. It has also been shown to promote hair survival and growth, both in vitro and in vivo.
The production of autologous PRP involves extraction of a specific volume of the patient's whole blood, which is then placed in an automated centrifuge to separate the layers of whole blood by their specific weight into 3 separate layers: (1) platelet-poor plasma, (2) platelet-rich plasma and (3) red blood cells.
The patients were divided into two groups (A and B): group A received treatment with PRP on the right half-head and the placebo on the left half-head, whereas group B received treatment with PRP on the left half-head and the placebo on the right half-head.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Prospective Double Blind, Placebo Controlled Study to Assess the Efficacy of Platelet-Rich Plasma on the Treatment of Androgenetic Alopecia|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||November 2015|
Briefly, for PRP preparation, approximately 18 mL of blood from each patient is drawn into a tube containing 3,8 % sodium citrate. The tubes were centrifuged at 450 g for 8 minutes, resulting in three basic layers: an erythrocyte layer at the bottom of the tube, a PRP layer in the middle, and a platelet-poor plasma (PPP) layer at the top of the tube. After removing the platelet-poor plasma (PPP) layer, the PRP is obtained, activated with 10 % calcium chloride.
In the same patient, PRP will be injected to half-head and in the other half-head will be injected with saline solution (placebo).
This study includes 4 visits: 3 visits (with 1-month interval) and 1 visit of follow-up (month 6).
PRP/Saline: Two groups were defined: group A and group B. Group A received treatment with PRP on the right half-head and placebo on the left half-head while group B received administration of PRP on left half-head and placebo on the right half-head.
Same patient will be injected with PRP and a saline solution. Each patient will be injected on half-head.
- Determine the treatment efficacy by measuring hair regrowth score for each side of scalp. [ Time Frame: 6 months ]
- Determine the treatment efficacy by measuring hair density for each side of scalp [ Time Frame: 6 months ]Determine the treatment efficacy by measuring mean hair density for each side of scalp using the trichogram analysis.
- Determine the treatment efficacy by measuring anagen/telogen ratio for each side of scalp [ Time Frame: 6 months ]Determine the treatment efficacy by measuring anagen/telogen ratio for each side of scalp using the trichogram analysis.
- Global photographs of three areas of the scalp (evaluation of hair growth will be assessed by comparison of standardized images) [ Time Frame: 6 months ]The evaluation of hair growth will be assessed by comparison of standardized images between baseline and 6 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02393040
|Universitat Internacional Catalunya|
|Barcelona, Spain, 08195|
|Principal Investigator:||Rubina Alves, M.D.||Specialist Dermatology, Universitat Internacional Catalunya|
|Study Director:||Ramon Grimalt, M.D.; PhD||Prof. Dermatology, Universitat Internacional Catalunya|