NCT02157090已完成不适用
Clinical Assessment of the Effectiveness and Safety of Herpes Patch SOS (Hansaplast®) Based on Hydrocolloids Without Active Substances in the Treatment of Herpes Simplex Labialis in Comparison to a Competitor's Product (Herpes Vesicle Patch of COMPEED®)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- The primary endpoint of this study was the Subjects Global Assessment of Therapy (SGAT) at final visit.
研究概览
简要总结
Recent clinical studies showed, that a hydrocolloid patch is effective, well tolerated and comparable with aciclovir cream 5 % for the treatment of HSL lesions, while affording additional benefits of wound protection, discretion and relief of social embarrassment. The aim of the actual study was the clinical assessment of the effectiveness and safety of Hansaplast® SOS Herpes Patch (HPHP) in comparison to Compeed® Herpes Vesicle Patch (CHP) in treating HSL. Both products are CE-certificated and are available at the market for medical devices.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 18 years old
- •with a history of recurrent HSL of the lips and/or perioral skin
- •lesions typically manifesting as classical lesions
- •duration of HSL symptoms not more than three days
- •haven´t used acyclovir or other cold sore therapies
排除标准
- •pregnancy
- •lactating women
- •women of child-bearing age without medically secured contraceptions
- •topical or systemic therapy with analgesic
- •anti-inflammatory or antiviral agents within the last 2 weeks
- •topical therapy within the treatment area
- •systemic therapy with cytostatics or immunosuppressants
结局指标
主要结局
The primary endpoint of this study was the Subjects Global Assessment of Therapy (SGAT) at final visit.
次要结局
- Development of lesion size.
- Clinician-assessed lesion stage at onset of the study and at visit 2 and the final visit 3.
- Number of patients with healed HSL lesions on day 5 and day 10 (assessed by clinician)
- Assessment of the local compatibility by patient and by investigator.
- Blinded clinician global assessment (IGAT) at the end of therapy.
- The number of study subjects with vesicles at onset of the study and at visit 2 and the final visit 3.
- Clinician-assessed time to complete healing from begin of the study.
- Time to complete healing of HSL after beginning of signs and symptoms.
- The severity and duration of subject-assessed individual signs and symptoms.
研究者
研究点 (2)
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