2023-507925-41-00招募中3 期
Phase III multicenter, prospective, randomized, double-blind study comparing the efficacy and safety of therapy for scabies with two differently concentrated permethrin creams.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 218
- 试验地点
- 13
- 主要终点
- The primary endpoint of this study was defined as the clinical efficacy (yes/no) after completion of treatment (depending on the success of treatment with V1 after 14 or after the second treatment after a total of 28 days).
研究概览
简要总结
The primary objective of the study is to demonstrate the superiority of the clinical efficacy of the new Permethrin Cream 10% for scabies compared to the standard therapy with Permethrin Cream 5% (primary objective).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •confirmed acute scabies disease: detection of mites and/or mite nymphs and/or mite larvae, by reflected light microscopy or by light microscopy of skin samples, at predilection sites typical of scabies
- •age between 18 and 85 years
- •written informed consent of the study participant or of all legal guardians and the study participant
- •feasible application of the trial medication by trained specialist personnel at the trial site
排除标准
- •Pre-treatment with antiscabiosa in the last 14 days
- •Combined antiscabious treatment (i.e. simultaneous topical and systemic drug treatment of scabies) in the last 3 months
- •Known intolerance to permethrin, other pyrethroids, chrysanthemums or any of the other ingredients of the study medication
- •Scabies crustosa
- •Impetiginization/eczematization requiring inpatient treatment
- •Body weight > 120 kg
- •Pregnancy, breastfeeding
- •Clinically relevant immunodeficiency (of any kind, including extensive local therapy (>20% body surface) with corticosteroids > 2 weeks in the last 4 weeks or ≥ 10 mg prednisolone equivalent >7 days in the last 4 weeks - even without signs of scabies crustosa)
- •Other serious illnesses which, in the opinion of the investigator, prevent the patient from participating in the study
- •Planned systemic use of corticosteroids
- •Planned or previous (last 4 weeks) use of systemic or cutaneous non-steroidal immunosuppressants
- •Obvious unreliability or unwillingness to cooperate
- •Inability to understand and comply with study instructions
- •Known alcohol, medication or drug addiction
- •Placement in a facility where people live together for a longer period of time, are cared for or receive medical care, and where close skin-to-skin contact is common (e.g. retirement and nursing homes, facilities for people with disabilities, shelters for the homeless, initial reception facilities/emergency accommodation, hospitals) or placement in an institution ordered by a court/authority
- •5 or more close contacts (persons with close, extensive skin-to-skin contact with the scabies patient for more than 5-10 minutes)
- •Close contact person who refuses scabies treatment or for whom treatment is not possible (According to the RKI, contact persons of a scabies patient are all persons who have had close, extensive skin-to-skin contact with the patient over a longer period of time (longer than 5-10 minutes), e.g. by sleeping together in the same bed, cuddling, body care and caressing of small children, sexual intercourse, body care of sick persons)
- •Dependence on sponsor or investigator
- •Previous participation in a clinical trial in the last 30 days or in the same clinical trial
结局指标
主要结局
The primary endpoint of this study was defined as the clinical efficacy (yes/no) after completion of treatment (depending on the success of treatment with V1 after 14 or after the second treatment after a total of 28 days).
The primary endpoint of this study was defined as the clinical efficacy (yes/no) after completion of treatment (depending on the success of treatment with V1 after 14 or after the second treatment after a total of 28 days).
次要结局
未报告次要终点
研究者
InfectoPharm
Scientific
INFECTOPHARM Arzneimittel und Consilium GmbH
研究点 (13)
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