EUCTR2010-021144-17-DE进行中（未招募）不适用
A phase III, multi-center, double-blind, randomized, vehicle controlled trial in a parallel-group design to evaluate the efficacy and safety of two formulations of Muxan containing 0.5 % or 1 % chloramine-T compared to vehicle in patients aged 12 years or older with acute herpes labialis
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
- •males and females aged 12 years or older (first part of the trial: only patients aged
- •18 years or older in Germany; second part of the trial: patients 12 years or older
- •expected not earlier than 2012) with recurrent herpes labialis episodes, at least 2
- •episodes of herpes lesions in the last year;
- •acute herpes labialis episode;
- •patients have to be present at the clinical site after onset of herpes labialis
- •symptoms within the next 16h to initiate treatment;
- •two symptoms of the subjective assessment of herpes symptoms” have to be
- •assessed with score 1 or one symptom with score 2 by the patients;
- •history of at least 50 % of herpes labialis episodes producing lesion with blister;
- •the patient or his/her legal representative must give written informed consent,
- •after having been informed orally and in writing about the anticipated benefits and
- •potential risks of the trial, as well as about details of the insurance taken out to
- •cover the patients participating in the trial;
- •female volunteers of childbearing potential must either be 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? yes
- •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
- •acne, suntan, eczema, hyperpigmentation, piercing or tattoos in the affected area;
- •evidence of drug or alcohol abuse;
- •history of positive result for hepatitis B surface antigen, hepatitis C virus, or HIV;
- •pregnancy or nursing;
- •multiple simultaneous lesions;
- •current significant skin disease within the affected area;
- •area of herpes labialis greater than 3 cm in diameter;
- •lesions that have already formed an ulcer or a crust (lesion stage score > 4);
- •known allergic reactions (intolerance or hypersensitivity) to components of the
- •investigational products (e.g. against chloramine-T);
- •treatment with systemic or locally acting medications which might counter or
- •influence the trial aim within two weeks before the baseline visit (e.g.
- •antihistamines or glucocorticosteroids);
- •cytotoxic, immunosuppressive or immunomodifying drugs within 3 month;
- •use of an anti-viral medication in the preceding 30 days;
- •congenital, acquired or corticosteroid-induced immunodeficiency;
- •symptoms of a clinically significant illness that may influence the outcome of the
- •trial in the four weeks before and during the trial (e.g. eczema, psoriasis, albinism,
- •or chronic vesiculobullous disorders);
- •in the opinion of the investigator or physician performing the initial examination the
- •patient should not participate in the clinical trial, e.g. due to probable
- •noncompliance or inability to understand the trial and give adequate informed
- •participation in the treatment phase of another clinical trial within the last four
- •weeks prior to the first administration of investigational drug in this clinical trial;
- •patient is institutionalized because of legal or regulatory order.
研究者
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