A Comparative, Randomized, Double blind, Multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Acyclovir 5% w/w + hydrocortisone 1% w/w Cream vs. Acyclovir 5% w/w cream in patients with recurrent cold sores.

Ajanta Pharma Ltd0 个研究点目标入组 100 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

•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

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