New PRP Study

[John P. Cole, MD]

I need to enroll patients in a new PRP study using the Emcyte PRP kit and protocol.

The study will involve treatment only in a small portion of the crown (4 square centimeters) either with PRP and microneedling or with saline and microneedling. You will not get treatment to the entire area of hair loss and you may get a placebo plus microneedling rather than PRP. You will not know which you receive, PRP or saline.

Patient follow-up is every 6 weeks for 52 weeks. we will measure hair density and hair mass at the beginning, 36 weeks, six months, and one year. Hair density will be measured by trimming hair.

Here are the inclusion criteria and exclusion criteria. This is an IRB multicenter study to evaluate not activated neutrophile poor PRP at 5-6 times concentration of platelets.

If you would like to participate in this study, please contact us at consults@forhair.com

"Inclusion Criteria."
"Subjects eligible for enrollment in the study must meet all of the following criteria:
1) Male with Norwood 3v, 4, or 5 androgenetic alopecia
2) At least 18 years old at time of study
3) Severity
Male: AGA classified as type 3 vertex, 4 or 5 utilizing Norwood-Hamilton classification diagnosed by history, physical examination, and either biopsy strong family history of androgenetic alopecia
4) Willing to comply with study requirements: including maintaining the same hair color and hairstyle throughout the study and not using alternate hair los treatments, such as finasteride, minoxidil or LLLT.
Exclusion Criteria."
"1) Younger than 18 years of age,
2) Medical conditions exclusion
a. History of abnormal thyroid conditions
b. Any unstable serious co-existing medical conditions
c. History or current evidence of any serious and/or unstable pre-existing medical or psychiatric disorder, in the opinion of the investigator
d. Current active systemic infection, or cancer
e. Current active use of anti-inflammatory drugs (NSAID’s, should be stopped 4 days before the blood draw)
f. Known platelet dysfunction syndrome
g. Patients on blood thinners
3) Hair and scalp disorders exclusion
a. History of hair transplantation in the treatment area"
"b. History of hair loss other than AGA including Autoimmune diseases (i.e. Lupus, Rheumatoid Arthritis, etc.), scaring alopecias, traumatic alopecias, and trilotichomania
c. Use of any product aimed at improving or correcting the signs of hair loss within 60 days of the start of the first treatment
o Use of light or laser treatment of scalp
o Use of dutasteride
o Use of finasteride
o Use of minoxidil (oral/topical)
o Use of drugs that will affect hair growth
d. Having a scalp skin disease at the area of treatment
4) History of allergy to lidocaine
5) History of use of steroids (i.e. prednisone, methylprednisolone, etc) that could interfere with the effectiveness of the NP-PRP, within the last 3 weeks."

[JJacobs152]

Great opportunity for patients to enroll in a true double-blinded prospective study to see the efficacy of PRP. I would jump on this but currently taking finasteride and topical minoxidil.

[John P. Cole, MD]

Great opportunity for patients to enroll in a true double-blinded prospective study to see the efficacy of PRP. I would jump on this but currently taking finasteride and topical minoxidil.

It's a good study; it's not easy to talk patients into this study since it is really double-blinded and placebo-controlled combined with a very small treatment area.

[mitcky]

I'd be first on line if this wasn't a double blind placebo controlled study.

Next time!

[John P. Cole, MD]

I hear you mitcky! To be honest, this is a great study and the sort of study we need. It's just very difficult to encourage patient participation. No one with hair loss wants to wait a year to find out if they got placebo or treatment. Plus, we are treating only 4 square centimeters. The inclusion category is patients with NW 3V, 4, and 5, which means you have 70 to 180 square centimeters of thinning or loss. No one wants to treat only 4 square centimeters when they are losing hair. I signed on to participate in the study, but I have a very difficult time procuring patients due to the inclusion categories and the double-blinded nature of the study. I've published papers comparing PRP on one side to PRP with Acell on the other side along with different types of PRP on each side, which it is easy to find patients to participate in. Placebo-controlled studies are not as easy to find patients. I can't blame patients for refusing to participate in this one.

[mitcky]

Doc- In your experience, does this PRP work? Does it work with Acell?

Any reading you can recommend? Thanks

[DenMitchel2]

It is a very tricky business as it involves a lot of legalities. Order an expert help who can answer tyour question better.

You are right. Clinical studies of a drug are a necessary stage in the development of any new drug, or in expanding indications for using a drug already known to doctors.

[DenMitchel2]

Recently, the role of clinical trials of drugs has increased in connection with the introduction of evidence-based medicine into practical public health. And chief among them is making specific clinical decisions for treating a patient based on rigorously proven scientific evidence that can be obtained from well-planned, controlled clinical trials. Read here https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6352170/

[jenn33]

Anyone tried? I need reviews and expiriences from people who did it

[MetcaAllfe]

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