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.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Combination of itching, burning, tingling and a dry feeling at the site of the future cold sore
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •Patients < 18 & > 60 years
- •History of hypersensitivity to the study drug or similar class of drug
- •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
- •Pregnant or nursing females
- •No intra-oral lesions or lesions above the nostrils and below the chin
- •No topical steroid use and no systemic antiviral current treatments within 7 days before the study
- •No known allergies to topical cosmetics
- •No use cosmetics on or around the mouth during the treatment period
- •No concomitant use of systemic corticosteroids or other drugs known to induce immune stimulation or immune suppression.
- •Participation in a clinical trial with an investigation drug within 30 days proceeding day one of this study
- •Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study.
结局指标
主要结局
Combination of itching, burning, tingling and a dry feeling at the site of the future cold sore
时间窗: Day 0, Day 3, Day 5 and Day 7.
次要结局
- Safety and tolerability(Day 0, Day 3, Day 5 and Day 7.)
- global assessment(Day 7)