Penciclovir clinical studies: Difference between revisions
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==Clinical Studies== | ==Clinical Studies== | ||
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. | |||
In two double-blind, placebo-controlled trials, 1516 patients were treated with DENAVIR (penciclovir cream) and 1541 with placebo. One or more local adverse reactions were reported by 3% of the patients treated with DENAVIR and 4% of placebo-treated patients. The rates of reported local adverse reactions are shown in Table 1. | |||
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Two studies, enrolling 108 healthy subjects, were conducted to evaluate the dermal tolerance of 5% penciclovir cream (a 5-fold higher concentration than the commercial formulation) compared to vehicle using repeated occluded patch testing methodology. The 5% penciclovir cream induced mild erythema in approximately one-half of the subjects exposed, an irritancy profile similar to the vehicle control in terms of severity and proportion of subjects with a response. No evidence of sensitization was observed.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = DENAVIR (PENCICLOVIR) CREAM [PRESTIUM PHARMA, INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=14d60b68-e5dd-475a-8517-576eb7894683#nlm34067-9 | publisher = | date = | accessdate = 6 January 2014 }}</ref> | |||
==References== | ==References== | ||
{{Reflist}} | {{Reflist}} | ||
Latest revision as of 15:55, 6 January 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Clinical Studies
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In two double-blind, placebo-controlled trials, 1516 patients were treated with DENAVIR (penciclovir cream) and 1541 with placebo. One or more local adverse reactions were reported by 3% of the patients treated with DENAVIR and 4% of placebo-treated patients. The rates of reported local adverse reactions are shown in Table 1.
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Two studies, enrolling 108 healthy subjects, were conducted to evaluate the dermal tolerance of 5% penciclovir cream (a 5-fold higher concentration than the commercial formulation) compared to vehicle using repeated occluded patch testing methodology. The 5% penciclovir cream induced mild erythema in approximately one-half of the subjects exposed, an irritancy profile similar to the vehicle control in terms of severity and proportion of subjects with a response. No evidence of sensitization was observed.[1]
References
- ↑ "DENAVIR (PENCICLOVIR) CREAM [PRESTIUM PHARMA, INC.]". Retrieved 6 January 2014.
Adapted from the FDA Package Insert.