Are placebo-controlled trials of creams for athlete’s foot still justified?

Abstract

The superiority of allylamines and azoles over vehicle in vehicle-controlled trials has been well established, and data demonstrating this fact have been available since the completion of early RCTs. These preparations are effective and safe, and investigators of RCTs evaluating topical treatments for athlete's foot need to choose potential comparators as control interventions in the light of this knowledge and to consider the ethics of withholding effective treatment from patients who seek treatment for this common foot infection.

Efficacy and safety of topical antifungals in the treatment of dermatomycosis: a systematic review

“…In 2008, Crawford et al. published a paper confirming that there is enough evidence to recommend the abandonment of vehicle‐controlled trials assessing topical treatments for athlete’s foot 14 …”

“…In 2008, Crawford et al published a paper confirming that there is enough evidence to recommend the abandonment of vehicle-controlled trials assessing topical treatments for athlete's foot. 14 Crawford and Hollis reported that direct comparisons of allylamines and azoles showed allylamines to be more efficacious than azoles. This difference among classes was detected in outcomes assessed 6 weeks after treatment began and appeared to remain over longer periods.…”

Eficácia de antifúngicos tópicos em diferentes dermatomicoses: uma revisão sistemática com metanálise

“…Accordingly, given the strength of the evidences found, clinical trials controlled by placebo evaluating topical antifungal drugs in the treatment of dermatomycoses are no longer justifiable; only clinical trials comparing two active treatments are reccomended. Crawford et al, in 2008, published an article confirming that there is enough evidence to recommend the abandonment of trials controlled by placebo evaluating topical antifungal drugs in the treatment of T. pedis 64 .…”

The placebo mystique: Implications for clinical trial methodology

“…It does seem that many trials continue to use placebo controls when appropriate active controls are available. Examples include several recent vaccine trials, 21–23 as well as trials in conditions as diverse as osteoporosis, 24,25 fungal dermatitis 26 and pulmonary arterial hypertension, 27 where arguably alternative control therapies are available. In recent years, a number of surgical interventions, such as arthroscopic knee surgery 28 and a trial of neurosurgery for Parkinson's disease, 29,30 have also been subjected to placebo‐controlled trial.…”