E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Staphylococcus super infection in atopic dermatitis |
|
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 | 10042566 |
E.1.2 | Term | Superinfection |
|
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 |
Changes in ESCORAD (SCORing Atopic Dermatitis of extremities) from baseline to day 14. |
|
E.2.2 | Secondary objectives of the trial |
Efficacy parameters: Changes in logarithm of staphylococcus-bacteria count from baseline to day 14. Changes in ESCORAD from baseline to day 7. Changes in single-ESCORAD of erythema, edema/papulation, oozing/crusting, excoriation, lichenification from baseline to day 7 and 14. Changes in logarithm of staphylococcus-bacteria count from baseline to day 7. Clinical and microbiological response rates for day 7 and 14. evaluation of skin parameters on a numeric scale by the investigator and the subject. Safety parameters: local frequency of side effects. Tolerance and efficacy evaluation on a numeric scale from 1-6 by the investigator and the patient. Compliance. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Signed ICF (informed consent form), patients aged 6 month to 50 years, first atopic dermatitis diagnosis at least 4 Week prior study entry, actual clinically manifested atopic dermatitis, disseminated symmetric eczemas of the limbs, SCORAD (SCORing Atopic Dermatitis) (ESCORAD) between 5 and 12, Staphylococcus superinfection. |
|
E.4 | Principal exclusion criteria |
Treatment with or need of oral or topical corticosteroids, non steroidal immunosuppressant agents, pimecrolimus, tacrolimus, antibiotics, immunomodulators, antihistamines; usage of soaps, lotions, creams and solutions with antiseptic ingredients e.g. potassium permanganate, chlorhexidine, povidone iodine; treatment with phototherapy or ultraviolet (UV) treatment or photochemotherapy (PUVA); peracute or erosive eczema; exsudative phases of atopic dermatitis; known hypersensitivity to triclosan or one of the ingredients of the cream; immunodeficiency; distinct impetigo, erysipelas or abscess; systemic bacterial or mycotic infections and severe viral systemic infections; severe systemic diseases; pregnancy and lactation; previous participation in a study within the last 30 days; alcohol and drug abuses. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Changes in ESCORAD from baseline to endpoint – calculated as difference between both ESCORADs taken from the CRF – both treatment-groups will be compared with double-sided t-test. The results are considered to be significant for a probability p < 0.05. |
|
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 | 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) | 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 | 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 |
|
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
| 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.8.6 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 | 0 |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | 0 |