E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
healthy volunteers
antiseptic for repeated, temporarily limited antiseptic treatment of superficial skin injuries |
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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 |
The primary objective is a significant reduction of total bacterial count after 3h, 6h and 1h of application compared to placebo. |
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E.2.2 | Secondary objectives of the trial |
•Significant reduction of total bacterial count after 1h, 3h and 6h of application compared to untreated. •Safety parameters (including skin tolerability, assessment of burning/itching and erythema) are documented and analyzed
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Caucasian men and women (skin type I to IV, Fitzpatrick et al. 1974) •Age 18 to 70 •Healthy skin at the test areas •Willingness to actively participate in the study and to come to the scheduled visits •Willingness to adhere to the study procedures including wash-out phase •Signed written informed consent to participate in the study •Negative urine pregnancy test (in female subjects of child bearing potential) •Reliable methods of contraception which result in a low failure rate (i.e. less than 1% per year) for women of childbearing potential (implants, injectables, combined oral contraceptives, some intrauterine-devices, sexual abstinence or vasectomised partner)
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E.4 | Principal exclusion criteria |
•Medication
-Systemic treatment with drugs interfering with the immune system (see table below):
Corticosteroids, antibiotics 30 days prior to study day 1 and during conduct of study Immunosuppressants 30 days prior to study day 1 and during conduct of study Antiphlogistics (minor pain relief medicine like acetylsalicylic acid or acetaminophene if not more than 1000 mg per day is allowed) 30 days prior to study day 1 and during conduct of study Regular intake of blood-thinning products such as Marcumar and acetylsalicylic acid -Topical treatment of test areas (see table below): Corticosteroids, antibiotics 2 weeks prior to study day 1 and during conduct of study Anti-inflammatory substances 2 weeks prior to study day 1 and during conduct of study Pretreatment with any of the test preparations tested in this study 30 days prior to study day 1 and during conduct of study Application of any products, other than the provided cleaning product, at the forearms such as moisturizers, perfumes, disinfection during washout-phase 14 days prior study day 1 and during conduct of study
Diseases
Atopic dermatitis, eczema, and/or sensitive, very dry skin Psoriasis and lichen ruber Active skin disease, e.g. skin tumors Moderate or severe illness within the last two weeks before first exposure Known infectious diseases (e.g. hepatitis or AIDS) Insulin-dependent Diabetes
•Known hypersensitivity against the test products, to ingredients of the test products, to products of similar chemical classes or to plaster •Pregnancy or lactation •Moles, tattoos, pigmentation or scars on the forearm that would influence the visual scoring •Hairy forearms •Intensive UV-light exposure within two weeks before the beginning of the test as well as during the study •Psychiatric conditions that might limit the participation in the trial and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing •Any history of drug addiction or alcoholism in the past 3 years •Subjects with poor compliance •Subjects, who are inmates of psychiatric wards, prison or state institutions •Participation in a clinical trial within the last 30 days prior to the start of this study •Subjects underlying any other restrictions due to the participation in other tests / test institutes •Employees of the study sites or of the Sponsor’s company •If in the opinion of the investigator the subject should not participate in the study for any reason
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E.5 End points |
E.5.1 | Primary end point(s) |
Comparison of test product with placebo at t1, t2 and t3 on log-transformed reductions to initial bacterial load for quantitative bacteriological results |
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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 | 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 | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
intra-individual comparison |
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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.8.3 |
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 | 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
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end of trial is last visit of last subject. |
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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 | 1 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |