EUCTR2014-003688-39-NL进行中（未招募）不适用
A Phase 2, Randomized, Vehicle-Controlled, Double-Blind, Proof-of-Concept Study to Evaluate Efficacy and Safety of Topical Ionic Contra-viral Therapy (ICVT) Comprised of Digoxin and Furosemide in Cutaneous Warts - Efficacy and safety of ICVT in healthy volunteers with warts
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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.Healthy subjects (male, non-pregnant female), 18 to 65 years of age, inclusive. (Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs,12-lead ECG, haematology, blood chemistry, and urinalysis.);
- •2.Body mass index (BMI) between 18 and 30 kg/m2, inclusive;
- •3.Fitzpatrick skin type I-II-III-IV;
- •4.Capable of tolerating treatment;
- •5.Free of clinical significant systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of Adverse Events
- •6. Have at least 2 (non-subungual) common warts or at least 2 (non-subungual) plantar warts on non-genital, non-facial skin of which at least 2 are 3mm in diameter in their longest dimensions on the plane of the skin
- •7.If female of childbearing potential, have a negative urine pregnancy test at Screening/Day 1, and is willing to use effective contraception during the study (i.e. oral, implanted, injectable, IUD, diaphragm, condom, tubal ligation, abstinence, or are in a monogamous relationship with a partner who has had a vasectomy);
- •8.Able to participate and willing to give written informed consent and to comply with the study restrictions;
- •9.Ability to communicate well with the investigator in the Dutch language;
- •10.Free of any clinical significant systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of Adverse Events;
- •11.Willing to refrain from using cosmetics or other topical products in the treatment area, or prohibited medications for the duration of the study;
- •12.Agree not to use any wart-removing product (prescription or over-the-counter) other than the study product during the course of the study
- •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 80
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Eligible subjects must meet none of the following exclusion criteria:
- •1.Any clinically significant abnormality as determined by medical history taking and physical examinations obtained during the screening visit that in the opinion of the investigator would interfere with the study objectives or compromise subject safety;
- •2.For women: a positive pregnancy test and/or nursing at screening or women who plan to become pregnant or are breastfeeding.
- •3.A positive test for drugs of abuse at screening;
- •4.History of alcohol or illicit drug abuse (alcohol abuse defined as alcohol consumption > 28 units/week);
- •5.Positive test results for Hepatitis B, Hepatitis C or HIV;
- •6.Have used salicylic acid or any other over-the-counter wart-removing product in the treatment area within 30 days prior to enrolment;
- •7.Have received cryotherapy in the treatment area within 60 days prior to enrolment;
- •8.Have required systemic intake of immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) within 30 days prior to enrolment or during the course of the study. Routine use of inhaled or intranasal corticosteroids during the study is allowed;
- •9.Have any current and / or recurrent pathologically relevant skin infections in the treatment area other than common warts (with the exception of herpes simplex virus labialis);
- •10.Have a known sensitivity to any of the investigational product ingredients, including digoxin and furosemide;
- •11.Clinically relevant abnormal laboratory results, ECG, vital signs, or physical findings at screening that in the opinion of the investigator would interfere with the study objectives or compromise subject safety;
- •12.Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times in the past year;
- •13.Any psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol;
- •14.Not having a general practitioner;
- •15.Not willing to accept information transfer which concerns participation in the study, or information regarding health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner;
- •16.Not willing to give permission to have the general practitioner to be notified upon participation in this study;
研究者
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