E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
hand and foot eczema, mild to moderate psoriasis vulgaris |
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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 |
Main objective is to gain evidence of the tolerability and safety of mometasone furoate 0.1% rich cream and ointment compared to vehicle, assessed by the severity and frequency of AEs/SAEs and their relationship to study medication during a 21 day treatment. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to evaluate the safety assessed by vital signs and the clinician’s and patient’s assessment of local skin reaction and irritability as well on a 4-point Likert scale during 3-week treatment. The efficacy is assessed by PGA on a 5-point scale. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Female or male individuals 18 and above 18 years of age in good general health • Individuals with mild to moderate plaque-type psoriasis (PASI < 10) or hand and foot eczema with at least two symmetrical lesions. • Individuals who are willing and able to provide informed consent • Individuals who are willing and able to follow the requirements for study participation • Individuals of child-bearing potential and their partners should use a highly effective method of birth control (failure rate < 1% per year), such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
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E.4 | Principal exclusion criteria |
• Pregnant or breast-feeding woman • Woman of child-bearing potential who plans to become pregnant or breast-feed. • Any therapy and/or application of systematic medication (including non-prescription products) that may interfere with the clinical evaluation such as immunosuppressives, biological systemic corticosteroids, ciclosporin, MTX, fumaric acid esters retinoid acids and/or treatment that may interfere with the skin barrier function within 30 days. • Individuals presenting with any other skin disease likely to interfere with the conduct of the study and/or the evaluation of the results • Individuals with infectious diseases (e.g. rosacea, varicella zoster, tuberculosis, syphilis), immunosupressive diseases as well as autoimmune diseases • Vaccination within 6 days prior to enrolment and during the study. • Individuals receiving topical therapy in the test area within the last 14 days prior to study entry • Excessive UV exposure or phototherapy (e.g. UVB, PUVA) within 14 days prior to drug application and during the conduct of the study. • Individuals with known hypersensitivity to any ingredients contained in the products used for treatment • Individuals who have participated in another clinical trial within the last 30 days prior to study entry • Individuals who are involved in the organisation of the trial
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E.5 End points |
E.5.1 | Primary end point(s) |
Due to the small sample size, the evaluation of the results will be carried out on a descriptive level. The primary objective is tolerability and safety of Momegalen® by assessment of AEs. Frequency, severity and relationship to study medication are presented in frequencies and percentages broken down by treatment group and visit. The secondary objective is to evaluate the safety assessed by vital signs and the clinician’s and patient’s assessment of local skin reaction and irritability, as well on a 4-point Likert scale during a 3-week treatment. The efficacy is assessed by PGA on a 5-point scale. Secondary objectives will be analyzed descriptively. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
intraindividual comparison |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
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
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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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | 21 |