Specializing in hair transplantation, hair restoration and hair transplants with hair loss clinics in New Jersey (NJ) & New York (NY)

• Has the product been approved by the FDA?
• Has the product been tested in FDA-approved clinical trials?
• Does product advertising include the listing of any side effects associated with use of the product?
• Is a medical examination recommended before use of the product?
• Is the product a "hair thickener" rather than a hair restorer?

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Has the product been approved by the FDA?

A product that stimulates the growth of hair is a product with a potent physiologic effect. What you should want to know is (1) does the product actually stimulate hair growth in a majority of persons who use it, and (2) if so, does it do so safely with minimal side effects? FDA approval assures you that both product effectiveness and product safety have been rigorously investigated in clinical trials.

Clinical trials are (1) medical investigative studies in which human beings are the test subjects, and (2) required by the FDA for the approval of a new drug or new uses of an existing drug. Before clinical trials are undertaken, a product has usually been studied in laboratory tests and in animals to determine mechanism of action, efficacy and safety. There are several types of clinical trials but the “gold standard” for unbiased study results is the randomized, double-blind controlled trial (RCT).

In the RCT, study subjects are randomly assigned to a study group or control group, and neither the investigators nor the study subjects and controls know who is receiving the treatment under investigation and who is receiving placebo (a non-drug with no physiologic effect - a “sugar pill”). Thus, RCTs are “double blind”both investigators and study subjects are “blinded” regarding who is receiving the investigative drug and who is receiving placebo. [Interestingly, in the clinical trials of FDA-approved finasteride and minoxidil a significant percentage of people receiving placebo reported new hair growth even though careful measurements and photographs showed that no new hair had been grown. This demonstration of ‘wishful thinking’ indicates the value of ‘blinded’ studies that eliminate bias, a tendency to see what you want to see.

It is important to keep this in mind when evaluating glowing anecdotal reports of effectiveness from people who used non-FDA approved remedies. RCTs are also designed to assure that the number of people being studied will yield a statistically meaningful result. Product effectiveness and product safety are two parameters always investigated in clinical trials. Pharmaceutical firms sponsor RCTs to gather the data necessary to win FDA approval for a new drug or new uses for an existing drug. FDA rules specify conditions under which the clinical trials are conducted. The studies are conducted by recognized medical investigators in hospitals and medical centers, or by physicians in private offices independent of any involvement by the firm paying for the trials. If a product wins FDA approval, it must be marketed within FDA guidelines and claims cannot exceed the findings of clinical trials. As of June 2001, two hair-restoration agents have been approved by the FDA—finasteride (Propecia®) and minoxidil (Rogaine®). [Top]

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