EUCTR2006-002828-42-SE进行中（未招募）不适用
An open label, multi-centre, phase III, subject initiated safety study of ME-609 in treatment of recurrent herpes simplex labialis in adolescents.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Medivir AB
- 入组人数
- 300
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. Male or female, 12 - 17 years of age at inclusion
- •2. General good health, as judged by the Investigator.
- •3. History of recurrent herpes labialis with at least two recurrences during the last twelve months, as based on an interview with the subject
- •4. Agreement to refrain from
- •- Using other topical medical, over-the-counter (OTC), or cosmetic products in or around the oral area during the herpes recurrence
- •- Mechanical disruption of the area affected by herpes labialis during the study recurrence
- •5. Subjects must themselves, and where appropriate their legally acceptable representative (as required by IRB/IEC and local legal requirements), voluntarily sign and date the informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Treatment with other systemic or topical antiviral agents within two weeks prior to inclusion
- •2. Treatment with systemic corticosteroids, or with topical corticosteroids in or around the oral area, within two weeks prior to inclusion
- •3. Any evidence of an immunosuppressed state of the subject due to underlying disease (e.g. HIV infection) or concomitant treatment (e.g. cancer chemotherapy)
- •4. Significant skin conditions that occur in the area typically affected by herpes recurrences, and that would interfere with assessment of lesions such as atopic dermatitis, acne, eczema, psoriasis, or chronic vesiculobullous disorders
- •5. Receipt of an investigational drug or immunomodulatory agent within two weeks prior to inclusion, or concurrent participation in another research study
- •6. History of immediate hypersensitivity or serum sickness reaction to any nucleoside analogue antiviral agent, or to any topical steroid, or to the vehicle
- •7. Nursing or pregnancy
研究者
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