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

NCT00736437 | Completed Phase 2

• 1 other identifier: 98-609-013
• Study Type: interventional
• Target: 417
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Herpes Labialis

Keywords

UV-induced; Herpes labialis; time to healing

Outcome Measures

Primary Outcomes (1)

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

  5 days

Secondary Outcomes (1)

• 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

  5 days

Study Arms (2)

1

EXPERIMENTAL

ME-609

Drug: ME-609

2

PLACEBO COMPARATOR

Vehicle

Drug: Vehicle

Interventions

ME-609 DRUG

Cream applied topically 6 times daily over the UVR exposed area

1

Vehicle DRUG

Treatment applied 6 times daily over the UVR exposed area

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medivir: lead

MeSH Terms

Conditions

Herpes Labialis

Interventions

ME 609

Condition Hierarchy (Ancestors)

Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Spotswood L Spruance, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 14, 2008
• First Posted: August 15, 2008
• Study Start: August 1, 1999
• Primary Completion: August 1, 2000
• Study Completion: August 1, 2000
• Last Updated: August 15, 2008

Record last verified: 2008-08