hand and foot eczema, mild to moderate psoriasis vulgaris
Conditions
Interventions
Product Name: Mometasone furoate 0.1% ointment containing 1 mg mometasone furoate / 1 g ointment
Pharmaceutical Form: Ointment
Pharmaceutical form of the placebo: Ointment
Route of administration of t
Sponsors
GALENpharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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. ;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. | — |
Countries
Germany
Outcome results
None listed