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

• Status: Completed
• Trial end date: 2000-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medivir
• Treatments: Acyclovir

Criteria

Inclusion Criteria:

• Aged 18 years or older

• A history of reactivation of recurrent herpes labialis with overexposure to sunlight in the last 12 months, or 2 or more cold sore lesions in the last 12 months

• Generally healthy as determined by medical history and verbal interview

• Females who were still able to conceive were to have had a negative pregnancy test on enrolment

• Fritzpatrick skin type category of I to IV

Exclusion Criteria:

• Previous inclusion in this study

• Participation in clinical investigational drug studies in the 4-week period prior to enrolment

• Participation in any herpes UVR reactivation study within the previous 3 months

• Previous herpes vaccination at any time

• Occurrence of herpes labialis (end of episode) within one month prior to enrolment

• Inflammatory, congenital or iatrogenic underlying immunodeficiency disorders

• Use of topical steroids in or near the face or on the forearms, systemic steroids (within 30 days from enrolment) or anti-inflammatory drugs (within 10 days from enrolment)

• Women who were pregnant, lactating or breast feeding

• Women of child bearing potential not using adequate contraception as judged by the investigator

• Recent history of alcohol or drug abuse which in the opinion of the investigator could interfere with compliance

• Significant skin disease such as atopic dermatitis or eczema, that would interfere with the assessment of lesions

• Allergy or hypersensitivity to steroids, acyclovir, penciclovir and/or other nucleoside analogues

• Administration of any drug commonly associated with photosensitivity (tetracycline, Retin A) within one week of UVR exposure

• Any antiviral therapy within 14 days prior to enrolment

• History of allergy or sensitivity to sunscreen

• History of herpes keratitis