NCT00644579Unknown2 期
bLAC - A Phase II Double-Blind, Placebo Controlled, Clinical Proof of Concept Trial of the Efficacy of 8 Weeks Treatment of Cutaneous Warts With bLAC in Immune Suppressed, Kidney Transplanted Patients
NatImmune A/S5 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- Reduction in the area of wart lesions located on fingers and/or palms and/or toes and/or soles of the feet, measured by an objective method by drawing of individual lesions
研究概览
简要总结
As many as 85 % of renal transplant patients may suffer from viral warts with a high degree of treatment resistance. Promising results of hLAC (human lactalbumin complex with lipid) point to a beneficial effect without noticeable side effects of bLAC (bovine lactalbumin complex with lipid). The aim of first clinical trial with bLAC is to show proof of concept in treatment of cutaneous wart lesions on hands and/or feet after local administration of bLAC in two dose groups to immune suppressed, kidney transplanted patients.
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
- •Cutaneous warts on ingers and/or palms and/or toes and/or soles of feet
- •Common warts and mosaic warts, diagnosed by an experienced dermatologist
- •Solitary wart lesions or 2 or more lesions per patient
- •Lesions present for more than 6 months
- •Men or women, aged 18 or above
- •History of kidney transplantation and immune suppressive therapy after transplant
- •Concomitant immune suppressive therapy stable for 6 months prior to randomization
- •Agreement from patient to allow photographs to be taken and used as part of trial data documentation (2 centres)
- •Women of childbearing potential must have negative pregnancy test at screening and must use adequate contraception
- •Ability to comply with requirements of trial
- •Written informed consent
排除标准
- •Verruca plana lesions
- •Suspected allergy to milk verified by serum analysis of IgE towards cow milk
- •Breastfeeding
- •Any local medication for any purpose other than wart treatment in target area during 4 weeks prior to randomization and during treatment period
- •Concomitant treatment with other wart therapies two weeks prior to randomization and during trial period
- •Intolerance towards bovine alpha-lactalbumin, oleic acid or any excipient in the formulation
- •Known HIV infection or any current uncontrolled infection
- •Any chronic or acute skin condition susceptible of interfering with evaluation of drug effect in this trial
- •Participation in any investigational trial or use of any investigational drug within 30 days prior to inclusion in this trial
- •Any health problems which according to Investigator's clinical judgment will make the patient unsuitable for inclusion in the trial
研究组 & 干预措施
1
Active Comparator
bLAC high dose
干预措施: bLAC (Drug)
2
Active Comparator
bLAC low dose
干预措施: bLAC (Drug)
3
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Reduction in the area of wart lesions located on fingers and/or palms and/or toes and/or soles of the feet, measured by an objective method by drawing of individual lesions
时间窗: Prospective
次要结局
- Clearance of index wart lesions. Time to clearance of warts. Recurrence rate of previously cleared wart lesions. Occurrence of new warts.overall changes of index warts lesions. Safety and tolerability.(Prospective)
研究者
研究点 (5)
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