E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The product is intended to be used by patients suffering from scabies infestation |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039512 |
E.1.2 | Term | Scabies infestation |
|
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 |
Assessment of local tolerability |
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E.2.2 | Secondary objectives of the trial |
Assessment of global tolerability (by the investigator and by the patient), Assessment of skin itching using a visual analogue scale score, Assessment of systemic exposure (concentration of permethrin metabolite CVA in urine, descriptive evaluation), Characterisation of safety and tolerability by assessment of Adverse Events, Assessment of efficacy according to the cure rate |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
· gender: male/female · age: ≥ 2 months of age · acute case of scabies · the patient or his/her legal representative must give written informed consent, after having been oral and written informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the subjects participating in the study |
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E.4 | Principal exclusion criteria |
· known allergic reactions to the active ingredient used or to constituents of the pharmaceutical preparation, as well as chrysanthemum and other composite plants · crusted (Norwegian) scabies · subjects with known skin allergies or multiple drug allergies · patient underwent treatment with any permethrin-containing scabicidal agent within the last 4 weeks · patients with chronic skin disorder · pregnant or breast feeding women · female patients who do not agree to apply adequate contraceptive methods as defined in Note for Guidance on Non-Clinical Safety Studies for the Conduct of Human Clincal Trials for Pharmaceuticals (CPMP/ICH/286/95, modification), November 2000 (e.g. uterine tube sterilisation, sexual abstinence or vasectomised partner or combination of anti-conceptive medication with condom and spermicidal products, diaphragm, temperature method, and some IUDs)· patients suspected or known not to follow instructions · patients or his/her legal representative who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study · previous participation in this study or participation in any other drug investigational trial within the preceding 30 days |
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E.5 End points |
E.5.1 | Primary end point(s) |
Assessment of local tolerability (subjective symptoms, descriptive evaluation) |
|
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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
multicenter, single-arm, single treatment, prospective |
|
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 | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
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 | Information not present in EudraCT |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 8 |