EUCTR2007-006738-33-SE进行中（未招募）1 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
atImmune A/S0 个研究点目标入组 120 人开始时间: 2008年7月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients with cutaneous warts located on fingers and/or palms and/or toes
- •and/or soles of the feet.
- •2. Index Wart lesions include: common warts (verruca vulgaris) and mosaic
- •warts. Index warts lesions must be diagnosed by an experienced dermatologist
- •on clinical basis.
- •3. Patients with a solitary wart lesion with a diameter of at least 1 cm2, or patients
- •with 2 or more wart lesions, the minimum area of each of the selected index
- •wart lesions is 0.5 cm². (A maximum of eight lesions is selected for treatment
- •and the maximum of total index lesion area = 9 cm²).
- •4. Index wart lesions should have been present for more than 6 months.
- •5. Men or women, aged 18 or above.
- •6. All patients should have a history of a kidney transplantation and immune
- •suppressive therapy after the transplant.
- •7. Concomitant immune suppressive therapy should have been stable for 6
- •monthsprior to randomisation, defined as no changes in number of drugs used,
- •but a change in doses for the individual immune suppressive drugs of ± 50 % is
- •allowed in the 6 months prior to randomisation
- •8. Agreement from the patient to allow photographs of the selected warts to be
- •taken and used as part of the trial data documentation (2 centres).
- •9. Women of childbearing potential must have a negative pregnancy test at
- •screening and must use adequate contraception (pill, contraceptive implant,
- •intrauterine device) during the trial.
- •10. Ability to comply with the requirements of the trial.
- •11. Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Verruca plana lesions.
- •2. Patients suspected of allergy to milk verified by serum analysis of IgG towards
- •3. Breastfeeding patients.
- •4. Any local medications for any purpose other than wart treatment in the target
- •area during 4 weeks prior to randomisation and during the treatment period
- •(weeks 0-8).
- •5. Concomitant treatment with other wart therapies two weeks prior to
- •randomisation in the present trial and during the clinical trial period.
- •6. Intolerance towards bovine a-lactalbumin, oleic acid, or any excipient in the bLAC
- •formulation.
- •7. Known HIV infection or any current uncontrolled infection.
- •8. Any chronic or acute skin condition susceptible of interfering with the evaluation
- •of the drug effect in this trial.
- •9. Participation in any investigational trial or use of any investigational drug within
- •30 days prior to inclusion in this trial.
- •10. Any health problems, which according to the Investigator’s clinical judgment will
- •make the patient unsuitable for inclusion in the trial.
研究者
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