Health Condition 1: B108- Other human herpesvirus infection Health Condition 2: null- Recurrent cold sores
Conditions
Interventions
Intervention1: Acyclovir 5% w/w + hydrocortisone 1% w/w Cream: 5 times daily at 4 hours interval for maximum period of 7 days or till the disease gets cured
Control Intervention1: Acyclovir 5% w/w cre
Sponsors
Ajanta Pharma Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis of Herpes Labialis confirmed by microscopic evaluation. 2. Clinical history of herpes simplex labialis with at least two recurrences during the past 12 months. The most recent previous episode must have healed at least 7 days before screening. 3. Less than 12 hours after prodrome initiation (i.e. local erythema w/o blistering, tingling and or burning sensation, soreness). 4. Written informed consent by patient to participate in the trial.
Exclusion criteria
Exclusion criteria: 1. Patients < 18 & > 60 years 2. History of hypersensitivity to the study drug or similar class of drug 3. Significant history or presence of gastrointestinal, liver or kidney disease or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications 4. Pregnant or nursing females 5. No intra-oral lesions or lesions above the nostrils and below the chin 6. No topical steroid use and no systemic antiviral current treatments within 7 days before the study 7. No known allergies to topical cosmetics 8. No use cosmetics on or around the mouth during the treatment period 9. No concomitant use of systemic corticosteroids or other drugs known to induce immune stimulation or immune suppression. 10. Participation in a clinical trial with an investigation drug within 30 days proceeding day one of this study 11. Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combination of itching, burning, tingling and a dry feeling at the site of the future cold soreTimepoint: Day 0, Day 3, Day 5 and Day 7.;Combination of itching, burning, tingling and a dry feeling at the site of the future cold soreTimepoint: Day 0, Day 3, Day 5 and Day 7.;Combination of itching, burning, tingling and a dry feeling at the site of the future cold soreTimepoint: Day 0, Day 3, Day 5 and Day 7.;Combination of itching, burning, tingling and a dry feeling at the site of the future cold soreTimepoint: Day 0, Day 3, Day 5 and Day 7.;Combination of itching, burning, tingling and a dry feeling at the site of the future cold soreTimepoint: Day 0, Day 3, Day 5 and Day 7.;Combination of itching, burning, tingling and a dry feeling at the site of the future cold soreTimepoint: Day 0, Day 3, Day 5 and Day 7.;Combination of itching, burning, tingling and a dry feeling at the site of the future cold soreTimepoint: Day 0, Day 3, Day 5 and Day 7.;Combination of itching, burning, tingling and a dry feeling at the site of the future cold soreTimepoint: Day 0, Day 3, Day 5 and Day 7.;Combination of itching, burning, tingling and a dry feeling at the site of the future cold soreTimepoint: Day 0, Day 3, Day 5 and Day 7. | — |
Secondary
| Measure | Time frame |
|---|---|
| global assessmentTimepoint: Day 7;Safety and tolerabilityTimepoint: Day 0, Day 3, Day 5 and Day 7. | — |
Countries
India
Contacts
Public ContactDr Shailesh Singh
Ajanta Pharma Ltd, Advent
Outcome results
None listed