Pharmaceutical industry sponsored clinical trials are studies to confirm a drug is safe and effective to treat a specific medical problem. The Federal Drug Administration (FDA) guides the process. Safety assessments determine the frequency of visits, and the tests and examinations performed at each visit. In addition outcome assessments, tests and examinations to determine effectiveness of the drug, are performed.

A vast majority of these studies are performed only on adults. Thus, little is known about the safety and efficacy of the drugs use in children. By law, these drugs may be prescribed “off label” to children. In dermatology this includes drugs used to treat eczema, atopic dermatitis, psoriasis, acne, etc. The prescribing physicians use published information, ‘general knowledge’ among colleagues, as well as their own personal experience to determine when and which adult approved drug they prescribe to children and how to monitor them for safety.

Recently, the FDA has approached drug companies to initiate clinical trials to test the safety and efficacy of those drugs whose ‘off label’ use appears to be safe and efficacious in children. Children who enroll in these clinical trials will learn whether or not for themselves the drug is safe and effective.

Ameriderm Research, the research division of Advanced Dermatology & Cosmetic Surgery, often has these trials ongoing for children with acne, psoriasis, eczema, and atopic dermatitis. For more information, please call 386 523 0768 or visit our website ameridermresearch.com

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