Evaluate the Clinical Effectiveness of RegenKit Platelet-rich Plasma (PRP) in Androgenetic Alopecia Treatment

Study Overview
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Brief Summary
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Platelet rich plasma (PRP) therapy is a novel therapeutic modality that has seen broad applications for a number of medical indications including those in orthopedics, dentistry, and dermatology. In dermatology, its uses have included treatment of chronic wounds and facial rejuvenation. More recently, anecdotal reports have suggested some efficacy in the treatment of hair loss, but to the best of our knowledge, there has been only one published case series documenting its use for this indication.

Detailed Description
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This study was designed to better assess the efficacy of PRP in hair loss, we therefore propose to study interval intralesional PRP injections for patients with androgenetic alopecia (AGA). Androgenetic alopecia is the most common form of hair loss world-wide. Although there are currently numerous treatment options for this indication including minoxidil, 5-alpha reductase inhibitors and follicular unit transplant, many of the medical treatment options have undesirable side effects, particularly in women of child bearing age. These well-documented adverse reactions include impotency, hypertrichosis, and birth defects.

Official Title
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A Monocentric, Double-blind, Randomized, Active- and Placebo-controlled Split-scalp Study to Evaluate the Clinical Effectiveness of Platelet-rich Plasma (PRP) in the Treatment of Androgenetic Alopecia

Conditions
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Androgenetic Alopecia

Intervention / Treatment
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* Device: Autologous Platelet Rich Plasma
* Device: Saline solution injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women, age 18-60 with AGA Completed informed consent form Ludwig stage 1-2 for women Norwood Hamilton Stage 3 to 5 for men Exclusion Criteria: Pregnancy or breastfeeding Younger than 18 years Uses of minoxidil and/or 5-alpha reductase inhibitors (such as finasteride or dutasteride) within 3 months of enrolling in the study History of hair transplantation Use of any cosmetic product aimed at improving or correcting the signs of hair loss within 2 weeks prior to screening Facial cancer (squamous and basal cell carcinoma, melanoma) Hereditary or acquired hematologic/coagulation disorders such as: platelet dysfunction syndrome, critical thrombocytopenia, hypofibrinogenemia, impaired coagulation, drepanocytosis (sickle cell anemia). Hemodynamic instability Acute infection Auto-immune disease such as Hashimoto, rheumatoid arthritis, or lupus (exception: vitiligo and alopecia areata) Malignancy with or without metastatic disease Chemotherapy Dermatological diseases affecting the face (e.g. porphyria) Anticoagulant therapy Patients taking Aspirin or other NSAIDs (Nonsteroidal anti-inflammatory drugs) such as Nurofen, Voltaren, Diclofenac or Naproxen can participate, provided medication is interrupted 7 days before beginning of the treatment Patients taking vitamin E supplements can participate, provided medication is interrupted 14 days before beginning of the treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous Platelet Rich Plasma<br>Autologous Platelet Rich Plasma injection | Device: Autologous Platelet Rich Plasma<br>* Autologous Platelet Rich Plasma a novel therapeutic modality used in numerous applications. In dermatology, its uses have included treatment of chronic wounds and facial rejuvenation. More recently, anecdotal reports have suggested some efficacy in the treatment of hair loss.<br>|
| Placebo Comparator: Saline<br>Saline solution injection | Device: Saline solution injection<br>* Placebo is a saline solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the changes in hair density of androgenetic alopecia | Evaluate split scalp changes in hair density of androgenetic alopecia after 5 month treatment of Autologous Platelet Rich Plasma prepared with the RegenBCT-1 kit compared to other half of the scalp treated with saline solution. | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the changes of hair diameter and hair shedding in androgenetic alopecia | Evaluate the changes of hair diameter and hair shedding in androgenetic alopecia after 5 months treatment of Autologous Platelet Rich Plasma prepared with the RegenBCT-1 kit compared to other half of the scalp treated with saline solution. | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelet Rich Plasma, Hair Loss