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).
- Conditions
- Other human herpesvirus infection, Recurrent cold sores,
- Registration Number
- CTRI/2010/091/000445
- Lead Sponsor
- Ajanta Pharma Ltd
- Brief Summary
This study is s 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 100 patients with recurrent cold sores. The date of first enrollment will be 14 May 2010.
The primary outcome measures will be assessed by TZANCK test, Microscopic Examination of viral culture, Combination of itching, burning, tingling and a dry feeling at the site of the future cold sore, Swelling at the site of future cold sore, Lesions near the mouth, on the lips, tongue, gums, and the nose, blisters, Pain, Small, red pimple like bumps and Ulcer-like sores on day 0, 3, 5 and 7. The secondary outcome measures will be Safety and tolerability and global assessment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
- Clinical diagnosis of Herpes Labialis confirmed by microscopic evaluation.
- 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.
- Less than 12 hours after prodrome initiation (i.e. local erythema w/o blistering, tingling and or burning sensation, soreness).
- Written informed consent by patient to participate in the trial.
- Patients < 18 & > 60 years2.
- History of hypersensitivity to the study drug or similar class of drug3.
- 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 medications4.
- Pregnant or nursing females5.
- No intra-oral lesions or lesions above the nostrils and below the chin6.
- No topical steroid use and no systemic antiviral current treatments within 7 days before the study7.
- No known allergies to topical cosmetics8.
- No use cosmetics on or around the mouth during the treatment period9.
- 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 study11.
- 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
- Primary Outcome Measures
Name Time Method Combination of itching, burning, tingling and a dry feeling at the site of the future cold sore Day 0, Day 3, Day 5 and Day 7.
- Secondary Outcome Measures
Name Time Method Safety and tolerability Day 0, Day 3, Day 5 and Day 7. global assessment Day 7
Trial Locations
- Locations (3)
Aadit Hospital
🇮🇳Valsad, GUJARAT, India
Abhay Skin Care Clinic
🇮🇳Aurangabad, BIHAR, India
Shree Venkatesha Hospital and Polyclinic
🇮🇳Thane, MAHARASHTRA, India
Aadit Hospital🇮🇳Valsad, GUJARAT, IndiaDr Tejas ShahPrincipal investigator09824155909aadithospital@yahoo.com