Study to Assess Efficacy of Platelet-Rich Plasma in Androgenetic Alopecia

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Brief Title

Study to Assess Efficacy of Platelet-Rich Plasma in Androgenetic Alopecia

Official Title

A Prospective Double Blind, Placebo Controlled Study to Assess the Efficacy of Platelet-Rich Plasma on the Treatment of Androgenetic Alopecia

Brief Summary

      The purpose of this study is to determine the efficacy of treatment with Platelet-rich plasma
      on Androgenetic alopecia (compared with placebo), between six months and baseline.
    

Detailed Description

      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


Primary Outcome

Determine the treatment efficacy by measuring hair regrowth score for each side of scalp.

Secondary Outcome

 Determine the treatment efficacy by measuring hair density for each side of scalp

Condition

Androgenetic Alopecia

Intervention

PRP/Saline

Study Arms / Comparison Groups

 PRP/Saline
Description:  PRP/Saline
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).

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

Other

Estimated Enrollment

50

Start Date

January 2014

Completion Date

November 2015

Primary Completion Date

July 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Patients ≥18 years and < 65 years

          -  Male patients with a clinical diagnosis of AGA (stage II to V according to the
             Hamilton-Norwood Scale)

          -  Female patients with a clinical diagnosis of AGA (stage I to III according to Ludwig
             Classification)

        Exclusion Criteria:

          -  Patients with other types of alopecia, other than AGA

          -  Fasting < 3h prior of each injection

          -  Use of nonsteroidal anti-inflammatory drugs one week before treatment.

          -  Platelet count < 150 000 μL

          -  Alterations of coagulation

          -  Heavy smokers (> 20 cigarettes/day)

          -  Medications: anticoagulants/ acetylsalicylic acid

          -  Patient unable to accomplishing all fases of treatment
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Rubina Alves, M.D., , 

Location Countries

Spain

Location Countries

Spain

Administrative Informations


NCT ID

NCT02393040

Organization ID

UICatalunya


Responsible Party

Principal Investigator

Study Sponsor

Universitat Internacional de Catalunya


Study Sponsor

Rubina Alves, M.D., Principal Investigator, Specialist Dermatology, Universitat Internacional Catalunya


Verification Date

March 2015