Clinical trial NCT02393040: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Androgenetic Alopecia
Alopecia
Hair Loss
Keywords: Alopecia
Androgenetic Alopecia
Alopecia, Male Pattern
Hair loss
Platelet-Rich Plasma
Alopecia, Female Pattern
placebo
double-blind
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2015-03-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Determine the treatment efficacy by measuring hair regrowth score for each side of scalp.
timeFrame: 6 months
Secondary outcomes:
measure: Determine the treatment efficacy by measuring hair density for each side of scalp
timeFrame: 6 months
measure: Determine the treatment efficacy by measuring anagen/telogen ratio for each side of scalp
timeFrame: 6 months
measure: Global photographs of three areas of the scalp (evaluation of hair growth will be assessed by comparison of standardized images)
timeFrame: 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Universitat Internacional Catalunya
Study officials:
affiliation: Specialist Dermatology, Universitat Internacional Catalunya
name: Rubina Alves, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Prof. Dermatology, Universitat Internacional Catalunya
name: Ramon Grimalt, M.D.; PhD
role: STUDY_DIRECTOR
References: