Clinical trial NCT02591355: Evaluate the Clinical Effectiveness of RegenKit Platelet-rich Plasma (PRP) in Androgenetic Alopecia Treatment
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Androgenetic Alopecia
Keywords: Platelet Rich Plasma
Hair Loss
Lead sponsor: Regen Lab SA
Sponsor class: INDUSTRY
Collaborators: name: RegenLab USA LLC
First posted: 2015-10-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the changes in hair density of androgenetic alopecia
timeFrame: 5 months
Secondary outcomes:
measure: Evaluate the changes of hair diameter and hair shedding in androgenetic alopecia
timeFrame: 5 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: New York
country: United States
facility: NYU Dermatologic Associates
state: New York
Study officials:
affiliation: NYU School of Medicine, Langone Medical Center, New-York University
name: Jerry Shapiro, MD
role: PRINCIPAL_INVESTIGATOR
References: