E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | |
E.1.1.1 | Medical condition in easily understood language | |
E.1.1.2 | Therapeutic area | Diseases [C] - Parasitic Diseases [C03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 | E.1.2 | Level | LLT | E.1.2 | Classification code | 10039511 | E.1.2 | Term | Scabies | E.1.2 | System Organ Class | 10021881 - Infections and infestations | |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 | E.1.2 | Level | PT | E.1.2 | Classification code | 10063409 | E.1.2 | Term | Acarodermatitis | E.1.2 | System Organ Class | 10021881 - Infections and infestations | |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial | Increasing numer of patients with scabies. Decreasing respond to Infectoscab 5% Creme. | Zunehmende Patientenzahlen mit Skabies-Infektion. Abnehmendes Ansprechen auf Infectoscab 5% Creme. | |
E.2.2 | Secondary objectives of the trial | not applicable | not applicable | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria | light-microscope confirmed scabies - ages ≥6 years (when parents are treating) | - auflichtmikroskopisch nachgewiesene Skabies - Alter ≥6 Jahre, sofern die Behandlung durch ein Elternteil stattfindet | |
E.4 | Principal exclusion criteria | Scabies norvegica/crustosa use of Infectoscab 5% creme in the past 4 weeks or multiple application without response in the last 6 months. unse of ivermectin orally in the past 3 months sensitivity/allergy against Infectoscab 5% creme (e.g. Permethrin, Cetylstearylalkohol (Typ A) or Sorbinsäure) pregnancy or breast-feeding woman mental retardation, alcohol abuse or non-compliance | Skabies norvegica/crustosa - Anwendung von Permethrin-haltigen Cremes (z.B. Infectoscab 5% Creme®) in den letzten 4 Wochen oder mehrmalige (≥2x à 2 Applikationen) Anwendungsfrequenz Permethrin-haltigen Cremes ohne berichtete nachfolgende Abheilung in den letzten 6 Monaten. -Anwendung von Ivermectin oral in den letzten 3 Monaten. - bekannte Überempfindlichkeit gegen den Wirkstoff Permethrin oder den Emulgator Cetylstearylalkohol (Typ A) oder Sorbinsäure - Patienten, die aufgrund ihrer körperlichen Entwicklung oder ihrer klinischen Verfassung nicht in der Lage sind, die Behandlung zu verstehen und durchzuführen - Schwangerschaft und Stillzeit - Alkoholabusus, mentale Dysfunktion oder andere Faktoren, die zu mangelnder Zusammenarbeit führen können | |
E.5 End points |
E.5.1 | Primary end point(s) | Therapy with Infectoscab 5% Creme (days 0 and 7 whole body) has a failure rate of >30% | Die Therapie mit Infectoscab® Creme in der konventionellen Anwendung (Tag 0+7 Ganzkörper) ist in >30% der Fälle nicht wirksam. | |
E.5.1.1 | Timepoint(s) of evaluation of this end point | |
E.5.2 | Secondary end point(s) | additional application of Infrectoscab 5% Creme at primary affected regions (e.g. hands, feet, genitals) for 7 consequtive days can lead to a higher curing rate. | Die zusätzliche Behandlung der primär betroffenen Regionen (Hände und/oder Genitalregion und/oder Füße) an 7 aufeinander folgenden Tagen kann zu einer verbesserten Abheilungsrate führen. | |
E.5.2.1 | Timepoint(s) of evaluation of this end point | |
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description | Infectoscab 5% Creme | Infectoscab 5% Creme | |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 | The trial involves single site in the Member State concerned | Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 | Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial | withdrawal of informed consent - pregancy -not tolerable AE - states manecing the health of the patients. | - Rücknahme der Einwilligung des Patienten - Eintritt der Schwangerschaft - Nicht tolerierbare, unerwünschte Ereignisse - Andere Umstände, welche die Gesundheit des Probanden gefährden würden, wenn er weiterhin an der Studie teilnehmen würde | |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |