Topical treatment of plaque psoriasis Skin and Connective Tissue Diseases Plaque psoriasis
Conditions
Interventions
7-day treatment with Daivonex® 0.005% cream (calcipotriol 50 µg/g) twice a day (every 12 hours) topically applied on the back
Sponsors
Polichem SA
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Informed consent: signed written informed consent before inclusion in the study 2. Sex and age: males, 18-55 years old inclusive 3. Body Mass Index: 18.5-30 kg/m2 inclusive 4. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting position 5. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
Exclusion criteria
Exclusion criteria: 1. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study; in particular skin damages, tattoos or any abnormal findings in the back 2. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness 3. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study 4. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study; known or suspected disorders of calcium metabolism associated with hypercalcaemia 5. Medications: medications, including over the counter medications and herbal remedies, calcium, vitamin D or vitamin-like medicines (e.g. calcitriol) for 2 weeks before the start of the study 6. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study 7. Blood donation: blood donations for 3 months before this study 8. Drug, alcohol, caffeine, tobacco: history of drug, alcohol [>2 drinks/day, defined according to the USDA Dietary Guidelines 2010], caffeine (>5 cups coffee/tea/day) or tobacco abuse (=10 cigarettes/day) 9. Drug test: positive result at the drug test at screening 10. Alcohol test: positive alcohol breath test at day -1 11.Diet: abnormal diets (3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma levels of calcipotriol after single and multiple dose administration of Daivonex® cream will be measured using a fully validated method. Timepoints: 1. Before the first drug administration 2. 3min, 6min, 9min, 12min, 15min, 20min, 25min, 30min, 40min, 50min, 1h, 1.5h, 2h, 3h, 6h, 9h and 12h after the first dose 3. Before last drug administration 4. 3min, 6min, 9min, 12min, 15min, 20min, 25min, 30min, 40min, 50min, 1h, 1.5h, 2h, 3h, 6h, 9h and 12h after the last dose | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse events (AEs) 2. Vital signs (BP, HR) 3. ECG 4. Physical examination 5. Laboratory parameters Measured at screening visit and at the end of the trial (final visit) | — |
Countries
Switzerland
Outcome results
None listed