Phase III Multicenter, Prospective, Randomized, Double-blind Study Comparing the Efficacy and Safety of Therapy for Scabies With Two Differently Concentrated Permethrin Creams.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 主要终点
- clinical efficacy (yes/no)
研究概览
简要总结
The multi-center, prospective, randomized, double-blind phase III clinical trial will primarily investigate the efficacy and safety of treatment of scabies with Permethrin Cream 5% (approved drug InfectoScab 5% Cream) in direct comparison with Permethrin Cream 10%.
The trial participants will be randomly assigned and blinded to either Permethrin Cream 5% or Permethrin Cream 10%.
详细描述
The SKABUP study is a multi-center, prospective, randomized, double-blind phase III clinical trial. The aim of this SKABUP study is to compare the efficacy and safety of topical therapy with permethrin 5% and permethrin 10% in a multicenter randomized double-blind setting in order to demonstrate the possible superiority of the 10% permethrin cream over the current standard therapy with permethrin 5% cream. In order to demonstrate a possible difference in efficacy as clearly as possible, the study will be conducted in dermatology clinics and without extensive exclusion of previous therapies in the patient's medical history.
The primary objective of the SKABUP study is the clincal efficacy (therapeutic success yes/no) after completion of treatment (one or - if necessary - two applications), i.e. treatment success on day 14 (for study participants with only one application of investigational product) or on day 28 (for study participants with repeated application of investigational product).
A total of 220 scabies patients aged between 2 and 85 years are to be included in the study (clinical trial). After 172 patients, however, recruitment will be stopped and an interim evaluation carried out. If there is proof of superiority, the study will be terminated; if there is no proof of superiority, it will be continued unchanged. Study drop-outs, i.e. patients included in the study with at least one application of an investigational product whose participation in the study ends prematurely, will not be replaced.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double-blind
入排标准
- 年龄范围
- 2 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 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 light microscopy of skin samples, at scabies-typical predilection sites
- •Age between 2 years and 85 years
- •Written informed consent of the study participant (if of legal age) or all legal guardians (for underage study participants < 12 years) or all legal guardians and the study participant (for underage study participants ≥ 12 years)
- •Practicable application of the trial medication by trained specialist staff at the trial site
排除标准
- •Pre-treatment with antiscabiosa in the last 14 days
- •Combined antiscabial treatment (i.e. simultaneous/simultaneous topical and systemic scabies treatment with medication) 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
- •Apparent unreliability or unwillingness to cooperate
- •Inability to understand and comply with study instructions
- •Known alcohol, medication or drug dependence
- •Placement in a facility where people live together for long periods of time, are cared for or receive medical care, and where close skin-to-skin contact is common, 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
- •Dependence on sponsor or investigator
- •Previous participation in a clinical trial in the last 30 days or in the same clinical trial
研究组 & 干预措施
5% Permethrin Creme
Permethrin Cream 5 % is the already approved standard therapeutic agent InfectoScab 5 % Cream, contains the active ingredient permethrin in a 5 % concentration and is used for the topical treatment of scabies. The cream is also used as a topical cream, e.g. after washing hands.
干预措施: 5% Permethrin Creme (Drug)
10% Permethrin Creme
Permethrin Cream 10 % also contains the active ingredient permethrin, but in double the concentration, and otherwise corresponds to the approved standard therapeutic agent InfectoScab 5 % Cream in terms of the main other ingredients. This is also used for the topical treatment of scabies, as well as for re-creaming, e.g. after washing hands.
干预措施: 10% Permethrin Creme (Drug)
结局指标
主要结局
clinical efficacy (yes/no)
时间窗: day 14 - day 28
The primary outcome criterion is defined as clinical efficacy (therapeutic success yes/no) after completion of treatment (one or - if necessary - two applications) i.e. treatment success on day 14 (for study participants with only one investigational product application) or on day 28 (for study participants with repeated investigational product application).
次要结局
- patients with new scabies efflorescences(day 0 - day 28)
- frequency of therapy success(day 0 - day 28)
- patients with "additional confirmed" treatment failure(day 0 - day 28)
- effectiveness at Visit 1(day 14)
- patients with evidence of mites(day 0 - day 28)
- patients with use of antiscabiosa not compliant with the protocol(day 0 - day 28)
- AEs, SAEs, ADRs, SUAWs(day 0 - day 28)
- itching(day 0 - day 28)