Limitations: This study excluded patients with comorbidities such as diabetes and
kidney impairment. As these are common disease states, this decision limits the
extrapolation of the study data to many populations. Not all patients (305 out of 489) had
culture-confirmed dermatophyte infections. This could diminish efficacy of both
products as they could potentially be treating infection that are not fungal and therefore
untreatable by these means. 511 patients entered this study; however, only 500 were used
for safety analysis. Dropouts are not mentioned, and number of patients in efficacy tables is not consistent. Baseline characteristics, along with data like adverse effects, were not
statistically examined. Some data, such as the time frame of improvement of skin lesions
or KOH study, is not presented in the text nor figures (in these cases, only a p-value is
presented). Power was not mentioned in the study to determine superiority. Results
presented are the end points of the study meaning the majority of the data collected at
each visit is not reported. Labs and urine samples were collected at each visit but were
only reported as adverse effects - if deemed drug-related - and were not used for efficacy
analyses.
Limitations: This study excluded patients with comorbidities such as diabetes and
kidney impairment. As these are common disease states, this decision limits the
extrapolation of the study data to many populations. Not all patients (305 out of 489) had
culture-confirmed dermatophyte infections. This could diminish efficacy of both
products as they could potentially be treating infection that are not fungal and therefore
untreatable by these means. 511 patients entered this study; however, only 500 were used
for safety analysis. Dropouts are not mentioned, and number of patients in efficacy tables is not consistent. Baseline characteristics, along with data like adverse effects, were not
statistically examined. Some data, such as the time frame of improvement of skin lesions
or KOH study, is not presented in the text nor figures (in these cases, only a p-value is
presented). Power was not mentioned in the study to determine superiority. Results
presented are the end points of the study meaning the majority of the data collected at
each visit is not reported. Labs and urine samples were collected at each visit but were
only reported as adverse effects - if deemed drug-related - and were not used for efficacy
analyses.
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