Clinical Trial: Efficacy of Acyclovir in Combination With a Glucocorticosteroid on UV-Induced Herpes Labialis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy of Acyclovir in Combination With a Glucocorticosteroid on UV-Induced Herpes Labialis

Brief Summary: The primary objective was to compare the efficacy of ME-609 cream vs placebo cream on the time to healing (loss of hard crust) of delayed classical herpes labialis (HSV) lesions experimentally induced after ultra violet radiation (UVR) exposure.

Detailed Summary: The primary objective was to compare the efficacy of ME-609 cream vs placebo cream on the time to healing (loss of hard crust) of delayed classical herpes labialis (HSV) lesions experimentally induced after ultra violet radiation (UVR) exposure. Secondary objectives were to compare the time to normal skin, incidence of lesion development (number and type of lesions), maximum lesion size, length of lesion stages, frequency/severity/duration of pain, frequency/severity/duration of tenderness, redness and/or oedema in the UVR exposed area, frequency of virus positive lesions, time to cessation of viral shedding and safety of ME-609 cream vs placebo cream.
Sponsor: Medivir

Current Primary Outcome: time to healing (loss of hard crust) of delayed classical herpes labialis (HSV) lesions experimentally induced after ultra violet radiation (UVR) exposure. [ Time Frame: 5 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: time to normal skin, incidence of lesion development, max lesion size, length of lesion stages, pain and tenderness, redness and/or oedema in the UVR exposed area, frequency of virus positive lesions, time to cessation of viral shedding and safety [ Time Frame: 5 days ]

Original Secondary Outcome: Same as current

Information By: Medivir

Dates:
Date Received: August 14, 2008
Date Started: August 1999
Date Completion:
Last Updated: August 14, 2008
Last Verified: August 2008