Trials / Completed
CompletedNCT00736437
Efficacy of Acyclovir in Combination With a Glucocorticosteroid on UV-Induced Herpes Labialis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 417 (actual)
- Sponsor
- Medivir · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ME-609 | Cream applied topically 6 times daily over the UVR exposed area |
| DRUG | Vehicle | Treatment applied 6 times daily over the UVR exposed area |
Timeline
- Start date
- 1999-08-01
- Primary completion
- 2000-08-01
- Completion
- 2000-08-01
- First posted
- 2008-08-15
- Last updated
- 2008-08-15
Source: ClinicalTrials.gov record NCT00736437. Inclusion in this directory is not an endorsement.