How to design and write a clinical research protocol in Cosmetic Dermatology

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Bagatin, Edileia [UNIFESP]
Miot, Helio Amante [UNIFESP]
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Cosmetic Dermatology is a growing subspecialty. High-quality basic science studies have been published; however, few double-blind, randomized controlled clinical trials, which are the major instrument for evidence-based medicine, have been conducted in this area. Clinical research is essential for the discovery of new knowledge, improvement of scientific basis, resolution of challenges, and good clinical practice. Some basic principles for a successful researcher include interest, availability, persistence, and honesty. It is essential to learn how to write a protocol research and to know the international and national regulatory rules. A complete clinical trial protocol should include question, background, objectives, methodology (design, variable description, sample size, randomization, inclusion and exclusion criteria, intervention, efficacy and safety measures, and statistical analysis), consent form, clinical research form, and references. Institutional ethical review board approval and financial support disclosure are necessary. Publication of positive or negative results should be an authors' commitment.
Anais Brasileiros De Dermatologia. Rio De Janeiro Rj: Soc Brasileira Dermatologia, v. 88, n. 1, p. 69-75, 2013.