E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients aged 18 and older suffering from at least one clinically diagnosed superinfected or impetiginised eczema such as e.g. • superinfected or impetiginised atopic eczema • superinfected or impetiginised allergic contact eczema • superinfected or impetiginised toxic contact eczema • (nummular) microbial eczema • superinfected or impetiginised eczema of unknown origin.
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021773 |
E.1.2 | Term | Infected eczema |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10014184 |
E.1.2 | Term | Eczema |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10014188 |
E.1.2 | Term | Eczema allergic |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10014191 |
E.1.2 | Term | Eczema atopic |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10014199 |
E.1.2 | Term | Eczema infected |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10014201 |
E.1.2 | Term | Eczema nummular |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051890 |
E.1.2 | Term | Eczema impetiginous |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000618 |
E.1.2 | Term | Actinic reticuloid-photosensitive eczema |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001712 |
E.1.2 | Term | Allergic eczema |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003641 |
E.1.2 | Term | Atopic eczema |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010803 |
E.1.2 | Term | Contact eczema |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10014206 |
E.1.2 | Term | Eczematous dermatitis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021773 |
E.1.2 | Term | Infected eczema |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049706 |
E.1.2 | Term | Eczematous dermatitis infected |
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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 aim of this study is to determine the efficacy and safety of a once daily topical application of the combinational cream (Octenidine (0.25%) + Prednicarbate (0.25%)) compared to a once daily application of Octenidine (0.25%), respectively to a once daily application of Prednicarbate (0.25%) cream mono-preparation in the treatment of super- infected or impetiginized eczema. The primary study objective is to compare the efficacy, regarding the rate of therapeutic success (defined as the combination of clinical and microbial success) at EOT (V5, day 14), as primary efficacy variable.
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are to compare the safety and to evaluate the patient’s compliance.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria: 1. Signed and dated written informed consent 2. Caucasian male and female patients 3. Aged ≥ 18 years 4. Have at least one clinically diagnosed superficial infected eczema confirmed by the following symptoms: • exudation/crusting • oozing • erythema • edema The cumulative score for these symptoms is at least grade 6 (according to a 4-point severity score used for grading each of the symptoms; Intensities: None = 0, Mild = 1, Moderate = 2, Severe = 3). 5. The minimal area of the target eczema (selected for complete efficacy evaluation) is not less than 2 cm2 6. Physical ability to apply the study preparations correctly and to follow the study restrictions and visits 7. Women of childbearing potential are allowed to participate in this study, only if they use a highly effective method of contraception.
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E.4 | Principal exclusion criteria |
1. Known hypersensitivity, intolerance or allergies against Octenidine, Prednicarbate or other ingredients of the investigational medicinal products (e.g. cetearyl alcohol etc.) 2. Patients who have general signs of systemic infections like fever, malaise, lymphagitis or swollen lymph nodes and/or need systemic antibiotic treatment 3. Patients who have a bacterial skin infection which, due to depth and severity, could not be appropriately treated with a topical antimicrobial or antiseptic medication 4. Have evidence of clinically significant or unstable medical conditions such as: • metastatic tumor or tumor with high probability of metastatic spread • immunosuppressive disorder (e.g. HIV) • hematologic, hepatic, renal, neurologic or endocrine disorder • insulin-dependent diabetes mellitus and/or hypoglycaemia if unstable or clinically manifested even under treatment 5. Diagnose of the following disease: • Known active tuberculosis or any history of past tuberculosis of skin • Suspected or proven parasitic infection of the treatment treatment site (e.g. scabies) • Psoriasis • Suspected or proven viral infection of skin (e.g. Herpes) 6. Localization of the eczema: • palms of the hands • sole of a foot • face 7. An area of more than 8 palms (corresponding to a body surface area of about 1200 cm2) is covered with superficial infected eczema 8. Have received the following topical treatments for any indication in the treatment areas within the designated time period before treatment with investigational medicinal product (IMP):
Treatment Time Period Topical antibiotics 6 weeks Topical antimycotics 2 weeks Topical steroids 2 weeks Topical immunomodulators 2 weeks Antiseptic agents 1 week
9. Have received the following systemic treatments within the designated period before treatment with IMP:
Treatment Time Period Interferon 6 months Cytotoxic drugs 6 months Immunomodulators or immuno-suppressive therapies 3 months Drugs known to have major organ toxicity 4 weeks
Antibiotics 4 weeks Antimycotics Corticosteroids (oral or injectable) 4 weeks Inhaled corticosteroids 4 weeks (>1200 microg/day for beclomethasone, or >600 microg/day for fluticasone) Antihistamines 48 hours
10. Have received any topical treatment with antibiotics, antimycotics, immunomodulators and corticosteroid preparations within the last 2 weeks before treatment with IMP 11. Any topical treatment with antiseptics agents within one week before treatment with IMP 12. Patients having any significant physical abnormalities (e.g. tattoos) in the potential treatment area that may cause difficulty with examination or final evaluation 13. Patients not willing to stop using skin care products (including sunscreens and make-ups) and washing products during the study within the treatment areas 14. Have any dermatological disease in the treatment areas or surrounding area that may be exacerbated by treatment with topical Prednicarbate or cause difficulty with examination (e.g. Rosacea, virus infections, vaccination) assessed by the investigator 15. Are known to be pregnant or lactating. 16. Are currently or within the past 8 weeks participating in another clinical study. 17. Any suspicion of current drug and/or alcohol abuse as assessed by the investigator. 18. Patient is institutionalized because of legal or regulatory order. 19. Employee of the study site or of the Sponsor’s company.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary efficacy variables: • Rate of therapeutic success of the target eczema at EOT visit (V5, day 14). Therapeutic success will be defined as microbial success and clinical success. Microbial analysis of microbial samples taken from the target eczema at EOT (V5) compared to those taken at Screening/Baseline (V1) will be used to evaluate the rate of microbial success, given if microorganisms (bacteria and fungi) detected at Screening/Baseline are at least almost cleared and without clinical relevance. The clinical status, assessed by the investigator’s visual inspection, will be graded using the Infected Eczema Severity Score (IESS). The 4-point IESS (Intensities: None = 0, Mild = 1, Moderate = 2, Severe = 3), incorporates typical signs and symptoms of superficial infected eczema (exudation/crusting, oozing, erythema, edema/induration, papulo-vesicles, pustules and scaling). Clinical success for the target eczema is given, if the cumulative IESS is not greater than grade 5 in maximum and if none of the symptoms evaluated exceeds grade 1 (mild intensity).
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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 | 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) | Yes |
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 | 20 |
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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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 | 5 |
E.8.9.1 | In the Member State concerned days | 0 |