E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Sensitive skin areas under non-occlusive and occlusive conditions |
Empfindliche Hautregionen unter okklusiven und nicht-okklusiven Bedingungen |
|
E.1.1.1 | Medical condition in easily understood language |
Sensitive skin areas and maximal humidity of the skin barrier by occlusion mimic those skin conditions to be treated without taking any health risk for patients, in particular spreading of infections |
Empfindliche Haut & max. Feuchtigkeit der Hautbarriere ahmen die zu behandelnden Hautzustände ohne Gesundheitsrisiken für Pat. nach, insbesondere nicht hinsichtlich der Ausbreitung von Infektionen |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
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 |
Testing of local tolerance |
Testung der lokalen Verträglichkeit |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Healthy adults of either gender, at least 25% having a history of atopic diseases |
Gesunde Erwachsene beiderlei Geschlechts, mindestens 25% mit atopischer Diathese |
|
E.4 | Principal exclusion criteria |
Known hypersensitivity against any of the ingredients of the products; major health trouble; pregnant or lactating women or inadequate contraception; aged <18 years; participation in another CT within the last 30 days. Additionally, in the period starting one week before treatment up to the end, not permitted are: treatment with other aminoglycoside antibiotics or neurotoxic substances; glucocorticoids and other immunotherapeutics as well as irritant or vasoactive compounds topically within the test region or systemically; massage within the test region |
bekannte Allergie gegen irgendeinen der Bestandteile des Prüfpräparats; bedeutende Gesundheitsprobleme; schwangere oder stillende Frau oder Gebärfähige ohne Kontrazeptionsschutz; Alter unter 18 Jahren; Teilnahme an einer anderen klinischen Studie innerhalb der letzten 30 Tage. Nicht zulässig sind ferner von einer Woche vor Beginn an bis zum Ende der Beobachtungsphase: weitere Aminoglykosid- od. neurotoxische Substanzen; Glukokortikoide und andere, die Immuntherapeutika sowie irritierende od. vasoaktive Substanzen topisch im Bereich der Prüfregion oder systemisch; Massagen im Bereich der Prüfregion
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E.5 End points |
E.5.1 | Primary end point(s) |
Use test: clinical scores for erythema, oedema/infitration, oozing/crusts, scaling, etat craquelé, pruritus, burning, tension, phototoxic and photosensitizing effects, transepidermal water loss patch test: clinical scores for erythema, oedema/infitration, oozing/crusts, discolouration/wrinkling, transepidermal water loss |
Anwendungstest: Klinische Scores für Erythem, Ödem/Infiltration, Nässen/Krusten, Schuppung und Etat craquelé, Pruritus, Brennen und Spannen, phototoxischen und photoallergischen Effekt, transepidermaler Wasserverlust Epikutantest: Klinische Scores für Erythem, Ödem/Infiltration, Nässen/Krusten, Verfärbung/Fältelung, transepidermaler Wasserverlust |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Before first application (D1), D3, D5; D8, D10, D12; D15 |
Vor der ersten Applikation (D1), D3, D5; D8, D10, D12; D15 |
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E.5.2 | Secondary end point(s) |
There is no splitting into primary and secondary endpoints in ths tolerance study |
In dieser Verträglichkeitsstudie wird nicht zwischen primären und sekundären Endpunkten getrennt |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Not applicable |
Nicht anwendbar |
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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 | No |
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 | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 |
intraindividueller Seitenvergleich |
intraindividual side comparison |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Natriumlaurylsulfat als Irritanskontrolle |
sodium lauryl sulfate as irritant control |
|
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | Yes |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |