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

Information source: Medivir
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Herpes Labialis

Intervention: ME-609 (Drug); Vehicle (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Medivir

Official(s) and/or principal investigator(s):
Spotswood L Spruance, MD, Principal Investigator, Affiliation: University of Utah

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: time to healing (loss of hard crust) of delayed classical herpes labialis (HSV) lesions experimentally induced after ultra violet radiation (UVR) exposure.

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

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: August 1999
Last updated: August 14, 2008

Page last updated: August 23, 2015

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