EUCTR2009-016302-16-DE进行中（未招募）1 期
A Randomized, Double-Blind, Vehicle-Controlled Study Evaluating the Safety and Efficacy of IDP-109 Solution in the Treatment of Patients with Verrucae Vulgares
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 76
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
- •All of the following criteria have to be met for inclusion of a patient in the study:
- •1. Male or female patients of any race, aged 18 years or older.
- •2. Verbal and written informed consent obtained from the patient. 3.Clinical
- •diagnosis of a total of 2 to 10 common warts on the dorsal sides of both hands,
- •with a maximum of 5 warts per hand, at the Baseline visit.
- •4. Individual wart area is calculated as the greatest diameter (mm) multiplied by the
- •perpendicular diameter (mm) at the Baseline visit. The total wart area should not
- •exceed 500 mm².
- •5. Target wart: largest wart present with an area of 4 mm2 to 100 mm2.
- •6. The patient is in good general health as determined by the investigator based on
- •the patient’s medical history and physical examination.
- •7. Female must have a negative urine pregnancy test at the Screening and the
- •Baseline visit, and must either be post-menopausal, surgically sterile
- •(hysterectomy or tubal ligation) or agree to use a reliable method of contraception
- •with a failure rate of less than 1 % per year when used consistently and correctly
- •such as implants, injectables, combined oral contraceptives, some intra uterine
- •devices [IUDs], sexual abstinence or vasectomized partner.
- •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
- •Patients are to be excluded from the study when one or more of the following conditions are met:
- •1. Female who is pregnant, nursing an infant, or planning a pregnancy during the
- •study period.
- •2. The total area of all dorsal warts does exceed 500 mm² at the Baseline visit.
- •3. Presence of mosaic or flat warts of the hands, warts on the palms, or periungual
- •or subungual warts of the hands (plantar warts on the hands are allowed but
- •these will not be treated with study drug).
- •4. Presence of any known immunodeficiency condition (cancer, chemotherapy,
- •genetic, HIV, or transplant).
- •5. Any previous use of imiquimod for any condition.
- •6. Known allergy or hypersensitivity to imiquimod or any of the other ingredients in
- •the study drugs.
- •7. Use of any wart therapy by any modality (including destructive procedures and
- •topical medications) within 4 weeks prior to the Baseline visit.
- •8. Use of any topical corticosteroids for any skin condition on the hands within 4
- •weeks prior to the Baseline visit.
- •9. Use of any systemic corticosteroids within 4 weeks prior to the Baseline visit or
- •during the study (a stable regimen of inhaled or intranasal corticosteroids that is
- •not expected to change during the study is allowed).
- •10. Use of any immunosuppressive or immunomodulatory medications by any route
- •of administration within 4 weeks prior to the Baseline visit or during the study.
- •11. Patient has a known history of significant non-compliance with previous wart
- •therapies as determined by the Investigator.
- •12. Use of any investigational drug or device within 30 days or 5 half-lives,
- •whichever is longer, prior to the Screening visit, or concurrent participation in
- •another clinical trial with an investigational drug or device.
- •13. Symptoms of a clinically significant illness within 4 weeks prior to the screening
- •visit or during the study that may influence the outcome of the study.
- •14. In the opinion of the Investigator or physician performing the initial examination
- •the patient should not participate in the study, e.g. due to probable
- •noncompliance or inability to understand the study and give adequately informed
- •15. Patient is a dependent person, i.e. a relative/family member of the Investigator
- •and/or is a member of the Investigator’s staff.
- •16. Patient is institutionalized because of legal or regulatory order.
- •17. Evidence of drug or alcohol abuse.
研究者
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