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

Primary Purpose

Androgenetic Alopecia, Alopecia, Hair Loss

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
PRP/Saline
Sponsored by
Universitat Internacional de Catalunya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Androgenetic Alopecia focused on measuring Alopecia, Androgenetic Alopecia, Alopecia, Male Pattern, Hair loss, Platelet-Rich Plasma, Alopecia, Female Pattern, placebo, double-blind

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitat Internacional Catalunya

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PRP/Saline

Arm 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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Determine the treatment efficacy by measuring hair density for each side of scalp
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
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)
The evaluation of hair growth will be assessed by comparison of standardized images between baseline and 6 months.

Full Information

First Posted
March 3, 2015
Last Updated
March 18, 2015
Sponsor
Universitat Internacional de Catalunya
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1. Study Identification

Unique Protocol Identification Number
NCT02393040
Brief Title
Study to Assess Efficacy of Platelet-Rich Plasma in Androgenetic Alopecia
Acronym
PRP
Official Title
A Prospective Double Blind, Placebo Controlled Study to Assess the Efficacy of Platelet-Rich Plasma on the Treatment of Androgenetic Alopecia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
November 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat Internacional de Catalunya

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia, Alopecia, Hair Loss
Keywords
Alopecia, Androgenetic Alopecia, Alopecia, Male Pattern, Hair loss, Platelet-Rich Plasma, Alopecia, Female Pattern, placebo, double-blind

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PRP/Saline
Arm Type
Experimental
Arm 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).
Intervention Type
Other
Intervention Name(s)
PRP/Saline
Other Intervention Name(s)
PRP, androgenetic alopecia, alopecia, hair Loss, placebo, saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Determine the treatment efficacy by measuring hair regrowth score for each side of scalp.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Determine the treatment efficacy by measuring hair density for each side of scalp
Description
Determine the treatment efficacy by measuring mean hair density for each side of scalp using the trichogram analysis.
Time Frame
6 months
Title
Determine the treatment efficacy by measuring anagen/telogen ratio for each side of scalp
Description
Determine the treatment efficacy by measuring anagen/telogen ratio for each side of scalp using the trichogram analysis.
Time Frame
6 months
Title
Global photographs of three areas of the scalp (evaluation of hair growth will be assessed by comparison of standardized images)
Description
The evaluation of hair growth will be assessed by comparison of standardized images between baseline and 6 months.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubina Alves, M.D.
Organizational Affiliation
Specialist Dermatology, Universitat Internacional Catalunya
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ramon Grimalt, M.D.; PhD
Organizational Affiliation
Prof. Dermatology, Universitat Internacional Catalunya
Official's Role
Study Director
Facility Information:
Facility Name
Universitat Internacional Catalunya
City
Barcelona
ZIP/Postal Code
08195
Country
Spain

12. IPD Sharing Statement

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

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