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

Androgenetic Alopecia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02591355
• Other study ID #: RL 03
• Status: Completed
• Phase: N/A
• Start date: September 6, 2017
• Est. completion date: November 18, 2019

Study information

• Verified date: December 2019
• Source: Regen Lab SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 18, 2019
• Est. primary completion date: November 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia

Intervention

Device:
• Autologous Platelet Rich Plasma
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.
• Saline solution injection
Placebo is a saline solution

Locations

Country	Name	City	State
United States	Axis Clinical Trials	Los Angeles	California
United States	NYU Dermatologic Associates	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Regen Lab SA	RegenLab USA LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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