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Treatment of genital herpes in males with imiquimod 1% cream: a randomised, double-blind, placebo-controlled study.
MedLine Citation:
PMID:  18370539     Owner:  NLM     Status:  In-Data-Review    
OBJECTIVE: The aim of this randomised, double-blind, placebo-controlled study was to examine the clinical significance, efficacy and tolerability of imiquimod 1% cream to manage patients exposed to first episodes of genital herpes.
PATIENTS: Male patients (n = 60), ranging in age between 18 and 50 years (mean 25.7 years), presenting for <6 days (mean 4.4 days) with culture-confirmed diagnosis of genital herpes, and bearing a total of 696 lesions (mean 11.6 lesions/ patient), entered the study and were randomised to receive a precoded 40g tube and instructions on how to apply the trial medication to their lesions twice for 5 consecutive days per week.
RESULTS: A marked clinical benefit from self-application of imiquimod 1% cream was demonstrated, resulting in both significantly shorter mean duration of healing than with the placebo (5.2 vs 14 days; p < 0.001) and more healed patients [23 of 30 (76.7%) vs 2 of 30 (6.7%); p < 0.0001]. Of the 60 patients, 54 (90%) reported no drug-related adverse effects. Two patients in the imiquimod group reported non-objective mild burning sensation and four experienced a transitory increase in their body temperature (>38 degrees C) accompanied by mild headache and malaise; however, such indications were not severe enough to cause discontinuation of the treatment, and resolved within 24 hours. Treatment was well tolerated by all the patients, with no dropouts. Among 25 healed patients, four had a relapse after 9 months.
CONCLUSION: Although the analogue of imiquimod 1% cream demonstrated mild to moderate subjective adverse effects, it was significantly more effective than placebo in treating patients with a first episode of genital herpes. Further clinical studies appear warranted.
T A Syed; O A Ahmadpour; S A Ahmad; S Shamsi
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Clinical drug investigation     Volume:  16     ISSN:  1173-2563     ISO Abbreviation:  Clin Drug Investig     Publication Date:  1998  
Date Detail:
Created Date:  2008-03-28     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9504817     Medline TA:  Clin Drug Investig     Country:  New Zealand    
Other Details:
Languages:  eng     Pagination:  187-91     Citation Subset:  -    
Department of Dermatology, University of California San Francisco, San Francisco, California, USA.
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