Evaluate the Clinical Effectiveness of RegenKit Platelet-rich Plasma (PRP) in Androgenetic Alopecia Treatment
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Dermatology, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 12/8/2018 |
| Start Date: | September 6, 2017 |
| End Date: | April 2019 |
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
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.
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.
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.
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.
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
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