A Randomized, Double-Blind, Active-Controlled, Subject Initiated Study Comparing ME-609 to Acyclovir Cream for Treatment of Recurrent Herpes Simplex Labialis in Immunocompromised Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 主要终点
- The primary variable was episode duration, measured from the start of treatment until loss of hard crust for an ulcerative recurrence and from the start of treatment to time of no signs or symptoms for a non-ulcerative recurrence (Investigator-assessed).
研究概览
简要总结
The purpose of this study is to evaluate the episode duration of a herpes labialis recurrence in immunocompromised patients treated with ME-609 or Acyclovir.
详细描述
The objective of this study was to evaluate the episode duration of a herpes labialis recurrence, following a 5-day treatment with 5-time daily topical administration of ME-609 or acyclovir cream, in immunocompromised adults, 18 years and older.
This interim report summarizes the results for short-term observations, i.e., during the initial study recurrence. A final study report will be prepared when the long-term follow-up is completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of recurrent herpes labialis with at least two recurrences during the twelve months prior to the study.
- •Stable HIV infection
- •CD4+ T-cell count 100 to 500/mm3
排除标准
- •Systemic treatment with other antiviral agent or corticosteroids within two weeks prior to and during the treatment period, except for antiretroviral treatment in HIV subjects
- •Topical treatment with other antiviral agent or corticosteroids within in or around the oral area within two weeks prior to study drug administration
- •Significant skin condition that occur in the area typically affected by herpes recurrences
- •Nursing or pregnancy
- •Concurrent cancer therapy
研究组 & 干预措施
1
ME-609 (5% acyclovir and 1% hydrocortisone)
干预措施: ME-609 (Drug)
2
Acyclovir in ME-609 vehicle (5% acyclovir)
干预措施: Acyclovir in ME-609 vehicle (5% acyclovir) (Drug)
结局指标
主要结局
The primary variable was episode duration, measured from the start of treatment until loss of hard crust for an ulcerative recurrence and from the start of treatment to time of no signs or symptoms for a non-ulcerative recurrence (Investigator-assessed).
时间窗: from start of treatment until loss of hard crust
次要结局
- The secondary variable was the time to next recurrence measured from the start of the study recurrence until the start of the next recurrence.(Start of recurrence until start of next recurrence)