NCT00490230已完成不适用
Assessment of Cutaneous Leishmaniasis Scar (Caused by Leishmania Major) for Cosmetic Outcome After Treatment With WR279396 (Paromomycin/Gentamicin Cream in Vehicle) Versus a No Treatment Control Group (Natural Healing)
U.S. Army Medical Research and Development Command1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2007年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Cosmetic outcome based on modified Vancouver Scar Score (mVSS)
研究概览
简要总结
Primary Objectives:
Assess whether CL (caused by Leishmaniasis major) lesions treated with WR279396 improved the cosmetic outcome compared with no treatment (natural healing)
详细描述
Secondary Objectives
- Evaluate the cosmetic outcome of CL lesions treated with "vehicle" compared with no treatment (natural healing)
- Evaluate the cosmetic outcome of CL lesions treated with "vehicle" compared with WR279396
- To determine whether CL lesions treated with vehicle improves the cosmetic outcome (compared with natural healing)
- To determine whether CL lesions treated with vehicle alone provides a cosmetic outcome similar to WR279396
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Included are volunteers who participated in WRAIR 813 (HSRRB Log # 9768.1) and those who participated in another CL study in/around the WRAIR 813 study site who had been assigned to a "no-treatment" (natural healing) arm. All volunteers will have had documented CL in the past that were treated with WR279396, vehicle, or no treatment (natural history), have signed informed consent, and are willing to comply with study assessments; age range: 5 to 75 years old.
- •For study subjects who were enrolled in WRAIR 813 in 2004 (WR279396 or vehicle treated):
- •Written informed consent obtained from the subject or guardian
- •Willing to meet the requirements of the single clinic visit
- •Prior data in the clinical site data base documenting a diagnosis of CL
- •Each lesion for inclusion in this study conforms to WRAIR 813: ³ 1 cm in diameter and was primarily ulcerative (i.e., not verrucous or nodular)
- •The index lesion and others to be scored were proven parasitologically by Giemsa slide smear
- •CL scars documented to be > 360 days old (clock starts at time of diagnosis)
- •No treatment of the lesions other than that received in the previous protocol
- •Study subjects from the earlier studies to serve as "no treatment" controls:
- •Written informed consent obtained from the subject or guardian
- •Willing to meet the requirements of the single clinic visit
- •Same age range as WRAIR 813: 5-75 years old at time of diagnosis
- •Prior data in the clinical site data base documenting a diagnosis of CL, and that the volunteer was assigned to the "no treatment" group
- •Each lesion for inclusion in this study will conform to WRAIR 813: at the time of diagnosis, ≥1 cm in diameter and described as primarily ulcerative (i.e., not verrucous or nodular)
- •At least 1 lesion that was proven parasitologically by Giemsa slide smear for inclusion in the earlier study.
- •CL scars documented to be > 360 days old (clock starts at time of diagnosis)
- •Never received any treatment of the lesions (natural healing) or applied any medication, such as herbal medication
- •Lesions present on the trunk or extremities, to match the WRAIR 813 study volunteers (no facial lesions were treated in the 2004 study)
排除标准
- •Potential volunteers without a prior documented diagnosis of CL
研究组 & 干预措施
WR 279,396
Experimental
CL lesions treated with WR 279396
干预措施: WR 279396 (Drug)
vehicle control
Placebo Comparator
CL lesions were treated with the vehicle alone
干预措施: WR 279396 (Drug)
结局指标
主要结局
Cosmetic outcome based on modified Vancouver Scar Score (mVSS)
时间窗: Day 360 or greater
The primary cosmetic outcome measure is the Clinical Scar Rating, based on a modified Vancouver Scar Score (mVSS). The primary efficacy endpoint is the percent of persons judged to have either a "superior (no scar)" or "excellent" rating (see below).
次要结局
未报告次要终点
研究者
研究点 (1)
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