NDLI: Safety and tolerability of combination acyclovir 5% and hydrocortisone 1% cream in adolescents with recurrent herpes simplex labialis.

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Safety and tolerability of combination acyclovir 5% and hydrocortisone 1% cream in adolescents with recurrent herpes simplex labialis.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Strand, Anders Böttiger, Disa Gever, Larry N. Wheeler, William
Description	Country affiliation: Sweden Author Affiliation: Strand A ( Department of Medical Sciences, Dermatology and Venereology, University Hospital, Uppsala, Sweden. anders.strand@medsci.uu.se)
Abstract	A Phase 3, open-label, multicenter study was conducted to assess the safety of the combination of 5% acyclovir and 1% hydrocortisone cream (AHC cream) in the treatment of recurrent herpes simplex labialis (HSL) in immunocompetent adolescents. Eligible subjects were aged 12 to 17 years and had a history of recurrent labial herpes with two or more episodes during the last 12 months. Subjects initiated treatment at the first signs or symptoms of a herpes recurrence-at the earliest prodromal phase and preferably before the presence of papules or vesicles. Subjects applied the cream topically five times per day for 5 days. Adverse events, categorization of recurrence (ulcerative or nonulcerative), and maximum lesion area (maximum area of an ulcerative lesion) were assessed. Of the 134 subjects analyzed for safety, 131 had data for categorization of recurrence at the post-treatment visit 3 ± 1 weeks after the last dose. Seventy-eight subjects (59.5%) had nonulcerative recurrences, and 53 (40.5%) had ulcerative recurrences. All 131 subjects reached the stage of normal skin, with no signs or symptoms, at the follow-up visit. The mean maximum lesion area in the 53 subjects with ulcerative herpes lesion was 39 mm(2). Five subjects reported five adverse events (secondary herpes labialis recurrences, n = 2; infectious rhinitis, n = 1; application site inflammation, n = 1; bronchial asthma, n = 1). All adverse events were of mild to moderate intensity. The results of this study demonstrate that the combination of AHC cream is well tolerated in the treatment of recurrent HSL in adolescents.
File Format	HTM / HTML
ISSN	07368046
Issue Number	1
Volume Number	29
e-ISSN	15251470
Journal	Pediatric Dermatology
Language	English
Publisher	Wiley
Publisher Date	2012-01-01
Publisher Place	United States
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Dermatology Discipline Pediatrics Acyclovir Administration & Dosage Adverse Effects Herpes Labialis Drug Therapy Hydrocortisone Administration, Topical Adolescent Anti-inflammatory Agents Antiviral Agents Child Drug Combinations Female Humans Male Secondary Prevention Treatment Outcome Clinical Trial, Phase Iii Journal Article Multicenter Study
Content Type	Text
Resource Type	Article
Subject	Dermatology Pediatrics, Perinatology and Child Health

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