A clinical toxicology study of a cryotherapic product in healthy male volunteers

Abstract

Gelomed® is a frozen emulsion consisting of methyl salicylate, menthol and camphor being indicated on inflammatory processes, especially traumatisms. The association of those active principles promotes a topical anti-inflammatory action explained byvasoconstriction, followed by a reflex vasodilatation response. The study’s outlining consisted of a non-randomized clinical trial with an open bias control. The project was approved by the ethics in research committee of the Federal University of Ceará. Twenty five healthy male volunteers were selected and each one of them received a daily 50g-topical application of Gelomed® for 20min, twice a day, for 14 uninterrupted days. The volunteers were only included in the study when considered healthy after clinical evaluation, physical tests and laboratorial exams that preceded the study. The evaluations were repeated in the 1st and 2nd weeks and 7 days after the end of the medicine administration. The formulation Gelomed® was well tolerated, however, adverse events were refered by 24% of the volunteers, although only two of those events were related to the formulation (itch and pain in the application site), being all of light intensity and not requiring any further treatment. The clinical exams, physical evaluation and laboratorial tests made before, during and after the research didn’t evidence toxicity signs in the several organs and appraised systems. The phase I clinical trial confirmed the formulation’s safety in the appraised sample, allowing the product to be used in larger populations in the determining of its therapeutic effectiveness.