NCT02483182已完成2 期
A Phase II, Randomized, Double-Blind, Parallel Group, Acyclovir-Controlled Study to Evaluate ZEP-3 Ointment for the Treatment of Cold Sores (Herpes Labialis).
Shulov Innovate for Science Ltd. 20121 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Clinician-assessed "Time to healing"
研究概览
简要总结
This is a phase II, prospective, randomized, double-blind, parallel group, acyclovir-controlled clinical study to evaluate the safety, tolerability and preliminary therapeutic efficacy of ZEP-3 ointment 1.0% for the treatment of cold sores (Herpes labialis), following five consecutive treatment days with five times daily topical administration.
详细描述
The primary endpoint of this study are:
- "Time to healing" - Clinician-assessed duration in days of herpes labialis episode.
- Patient-assessed duration and intensity of pain by Visual Analog Scale (VAS).
- Safety and tolerability following five consecutive treatment days with five times daily topical administration.
The secondary endpoints of this study are:
- Proportion of subjects with non - ulcerative herpes lesion.
- Time for herpes labialis recurrences
Subject safety will be assessed following treatment by ZEP-3 ointment 1.0% or acyclovir cream 5% treatment, using measurements of the following variables:
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior to enrollment in this study, candidates must meet ALL of the following inclusion criteria:
- •Patients suffering from recurrent Herpes labialis with history of at least 3 cold sores recurrences during the previous 12 months.
- •Participants, either male or female are between 18 and 75 years of age.
- •Patients arrive at the clinic with any symptom of an acute Herpes labialis episode.
- •Or, patients arrive at the clinic within 48 hours of treatment initiation for a recurrent Herpes labialis episode.
- •Patients with previous Herpes labialis episode must be healed for at least 14 days before baseline visit
- •Patients with no history of reaction to topical products.
- •Female subjects of childbearing potential must have a negative pregnancy test at screening and agree to use a proper contraceptive method during the study.
- •Participant understands the nature of the procedure and is willing and able to comply with all requirement of the protocol.
- •Patient is willing and able to provide written informed consent prior to any study procedure.
排除标准
- •Subject has abnormal skin conditions or significant facial hair at or near the investigational area
- •Subject has any body piercing in or around the area ordinarily affected by cold sores.
- •Subjects with a history of cardiac abnormalities.
- •Subject has a recent history of renal dysfunction or serious hepatic disease
- •Subject has an active malignancy or immunodeficient disease
- •Subject who is unwilling to stop using topical medical, OTC, cosmetics or facial skin care products in or around the oral area during the study period.
- •Subject requires chronic use of immunomodifying drugs or topical steroids on or near the face.
- •Subject requires chronic use of anti-viral medication.
- •Subject requires chronic use of analgesics, pain medication or non-steroidal anti inflammatory agents (NSAIDs).
- •History of allergic or adverse response to acyclovir, or any related anti-viral drug.
- •Subject has had an infection with HSV-1 isolates know to be resistant to acyclovir, valacyclovir, famciclovir, or ganciclovir.
- •Subject has had a herpes vaccine.
- •Females during pregnancy, lactation or breastfeeding.
- •Subject has a history of alcoholism or drug abuse within the preceding 12 months.
- •Subject is currently enrolled in another clinical trial involving the use of a drug and/or a device.
- •Any history which, in the Investigator's judgment, makes the subject ineligible or places the subject at undue risk.
- •Subjects with immune deficiency conditions including acquired immune deficiency.
研究组 & 干预措施
ZEP-3 ointment 1.0%
Experimental
Topical administration
干预措施: ZEP-3 ointment 1.0% (Drug)
Acyclovir cream 5%
Active Comparator
Topical administration
干预措施: Acyclovir cream 5% (Drug)
结局指标
主要结局
Clinician-assessed "Time to healing"
时间窗: Up to 14 days
次要结局
- Time for Herpes labialis recurrences(12 months)
研究者
研究点 (1)
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