A clinical Trial in patients with with recurrent cold sores. Clinical trial is to study efficacy, safety and tolerability of Acyclovir + hydrocortisone Cream in comparison toAcyclovir cream (reference product).

Phase 3

Completed

• Conditions: Health Condition 1: B108- Other human herpesvirus infectionHealth Condition 2: null- Recurrent cold sores

• Registration Number: CTRI/2010/091/000445
• Lead Sponsor: Ajanta Pharma Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified