EUCTR2007-000182-38-IT进行中（未招募）不适用
EFFICACY AND SAFETY OF A NEW TOPICAL FORMULATION OF ACYCLOVIR GEL (LP) IN THE TREATMENT OF HERPES SIMPLEX LABIALIS A RANDOMIZED, Single-BLIND, MULTICENTER, CONTROLLED CLINICAL TRIAL versus ACTIVE REFERENCE FORMULATION (ACYCLOVIR 5% CREAM) - ND
MIPHARM0 个研究点目标入组 180 人开始时间: 2007年6月14日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
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
- •- Both sexes, all ethnic backgrounds, outpatients, between 18 and 70 years of age, in good general health. - Subjects with a diagnosis of Herpes Simplex Labialis. The diagnosis is based on a clinical evaluation. - Ability to understand and comply with the prescriptions contained in the therapeutic protocol. - Subjects who have given their written informed consent in accordance with provisions of the pertinent excerpt of the Declaration of Helsinki.
- •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
- •- Subjects affected by diseases requiring the use of systemic or topical corticosteroids. - Concomitant use of other anti-herpetic/antiviral drugs - Concomitant use of anti-inflammatory medications or analgesics. - Concomitant use of any other drug administered as ointment, cream or gel, dermatological products, emollients, in the area of herpes labialis lesions. - Immunocompromised subjects. - Patients with herpetic stomatitis (first infection) - Patients with Herpes labialis severe symptoms or signs of more 24 hours in duration, intraoral lesions, or lesions within the nares. - Subjects with lesions wider than 2,0 cm2 - Traumatic loss of first crust - Subjects affected by severe renal, dismetabolic or hepatic failure which represent a risk to the subjects. - Presence of underlying medical conditions that might interfere with study completion. - Partecipation in any other study involving investigational or marketed products concomitantly or within one month prior to study entrance. - A history of alcoholism, drug abuse, psychological or other emotional problems that could invalidate informed consent or limit the subject compliance with protocol requirements. - breastfeeding females. - Necessity to have a concomitant therapy with any drug mentioned in the restrictions. - Subjects likely to be not compliant/uncooperative during the study, in the judgment of the clinical investigator.
研究者
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