E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Histamine-induced pruritus UVB-light-induced slight sunburn |
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E.1.1.1 | Medical condition in easily understood language |
Pruritus after application/injection of Histamine Sunburn after UVB-light exposition |
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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 |
Evaluate the efficacy of Anaesthesin 10% Salbe in pain on skin |
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E.2.2 | Secondary objectives of the trial |
Evaluate the efficacy of Anaesthesin 10% Salbe in pruritus on skin |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Age: ≧ 18 and ≦ 45 years • Body Mass Index of 19.0 – 29.0 (kg/m2) • Male healthy subjects • Subject able and willing to sign informed consent • No antecedents of atopic, allergic or neurological disease within three months prior to the study • No skin lesions or scars on the tested area and around (within 5 cm from the tested area) • No use of cosmetics, ointment or cream on the studied areas from one week prior to the initiation of test • No anti-inflammatory drug within one week prior to the study • No anti-histamines within three weeks prior to the study • No systematic antiallergic medication 7 days prior to the study • No topical emollient preparation 14 days prior to the study • No topical or systemic steroids 1 months prior to the study • No psychopharmacological drugs 1 year prior to the study • Non-smoker (more than one year) • No intake of drugs known for inducing photosensitivity (e.g. Thioxanthenes (chlorprothixene, thiothixene), Antifungals, Itraconazole, Voriconazole, 5-Fluorouracil, Amiodarone, Diltiazem, Quinidine, Enalapril, Dapsone, Cinnamates, Salicylates) • No large-area tattoo or skin lesions (e.g. cicatrice) on forearms or upper back |
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E.4 | Principal exclusion criteria |
• Unable to meet inclusion criteria. • Any concomitant illness or abnormal laboratory test which, in the investigator's opinion, would render the subject unsuitable for enrolment. • History of alcohol or drug abuse. • Known hypersensitivity to the product or excipients. • Other therapy that excludes the use of study treatment. • Participation in other clinical trials within the past 1 month. • Subjects with psoriasis, neurodermatitis or eczema. • Subjects treated with corticoids, cytotoxic drugs, cancer, HIV • The family of the investigators and the sponsor.
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E.5 End points |
E.5.1 | Primary end point(s) |
1. The difference of VAS of itch between the administered sites, on which Anaestherit 10% or placebo was applied.
2. Measurement of pain using the Algometer FPX to determine the strength needed to induce pain.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. after 1, 3, 6, 9, 12 and 30 min of application
2. before application, after 10, 20, 30 min and 1 and 6 hrs after application |
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E.5.2 | Secondary end point(s) |
1. Difference of itch between the administered site, on which Anestherit 10% or placebo was applied by using the “Eppendorfer-Juckreizfragebogen” (part 1b).
2. The difference of VAS of pain between the administered sites, on which Anestherit 10% or placebo was applied.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. after 1, 3, 6, 9, 12 and 30 min of application
2. before application, after 10, 20, 30 min and 1 and 6 hrs after application |
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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 | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
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 | Yes |
E.8.2.3 | Other | No |
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
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LVLS during follow up visit |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |