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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
Sponsor:
Information provided by (Responsible Party):
Rubina Alves, Universitat Internacional de Catalunya

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.

Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Alopecia Hair Loss Other: PRP/Saline Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PRP/Saline

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).

Other: PRP/Saline

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.

Other Names:
  • PRP
  • androgenetic alopecia
  • alopecia
  • hair Loss
  • placebo
  • saline




Primary Outcome Measures :
  1. Determine the treatment efficacy by measuring hair regrowth score for each side of scalp. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Spain
Universitat Internacional Catalunya
Barcelona, Spain, 08195
Sponsors and Collaborators
Universitat Internacional de Catalunya
Investigators
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Principal Investigator: Rubina Alves, M.D. Specialist Dermatology, Universitat Internacional Catalunya
Study Director: Ramon Grimalt, M.D.; PhD Prof. Dermatology, Universitat Internacional Catalunya

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Responsible Party: Rubina Alves, Specialist in Dermatology, M.D., Universitat Internacional de Catalunya
ClinicalTrials.gov Identifier: NCT02393040     History of Changes
Other Study ID Numbers: UICatalunya
First Posted: March 19, 2015    Key Record Dates
Last Update Posted: March 19, 2015
Last Verified: March 2015

Keywords provided by Rubina Alves, Universitat Internacional de Catalunya:
Alopecia
Androgenetic Alopecia
Alopecia, Male Pattern
Hair loss
Platelet-Rich Plasma
Alopecia, Female Pattern
placebo
double-blind

Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical