This is a phase 2, open-label, single-group, multicentre trial in which the investigational product, MC2-01 cream, is investigated in adolescent subjects (age 12 to 16 years, 11 months) with clinically diagnosed extensive psoriasis vulgaris.
The MC2-01 cream is designed for optimal patient satisfaction - it quickly absorbs into the skin leaving it nicely moisturized allowing patients to move on with daily routines. In this trial, subjects who fulfil all inclusion and exclusion criteria are enrolled in the trial and will apply one dose of trial medication topically once daily for 8 weeks. The purpose of the trial, is to determine the and pharmacokinetic parameters of MC2-01 cream in adolescent subjects under maximum use conditions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
MC2-01 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)
PRO SANUM a.s.
Prague, Czechia
Dept. of Dermatology, Venereology and Allergology
Frankfurt, Frankfurt/Main, Germany
Number of Participants With HPA (Hypothalamic-pituitary-adrenal) Axis Suppression at Week 4
Adrenal function will be assessed in a challenge test with an intravenous dose of cosyntropin. Measurement of serum cortisol levels pre- and post- stimulation is an accepted standard method used to evaluate adrenal suppression. The test consists of an initial blood sampling. Following the blood sample, an intravenous bolus injection of 0.25 mg cosyntropin is given. The serum cortisol concentration 30 min. after will reflect stimulation of the adrenal glands induced by cosyntropin. HPA axis suppression is define as serum cortisol below 18 µg/dL
Time frame: Week 4
Number of Participants With HPA (Hypothalamic-pituitary-adrenal) Axis Suppression at Week 8
Adrenal function will be assessed in a challenge test with an intravenous dose of cosyntropin. Measurement of serum cortisol levels pre- and post- stimulation is an accepted standard method used to evaluate adrenal suppression. The test consists of an initial blood sampling. Following the blood sample, an intravenous bolus injection of 0.25 mg cosyntropin is given. The serum cortisol concentration 30 min. after will reflect stimulation of the adrenal glands induced by cosyntropin. HPA axis suppression is define as serum cortisol below 18 µg/dL
Time frame: Week 8
Change in S-Calcium Metabolism at Week 4
Change from Baseline to Week 4 in albumin-corrected S-calcium
Time frame: Week 4
Change in S-Calcium Metabolism at Week 8
Change from Baseline to Week 8 in albumin-corrected S-calcium
Time frame: Week 8
Change in U-Calcium Metabolism at Week 4
Change from Baseline to Week 4 in Urinary Calcium/Creatinine ratio (mol/mol)
Time frame: Week 4
Change in U-Calcium Metabolism at Week 8
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Change from Baseline to Week 8 in Urinary Calcium/Creatinine ratio (mol/mol)
Time frame: Week 8
The Maximum Plasma Concentration [Cmax] of Betamethasone 17-propionate at Week 4
The Maximum Plasma Concentration \[Cmax\] of the metabolite of BDP, betamethasone 17-propionate measured at Week 4.
Time frame: Week 4
Time to Maximum Plasma Drug Concentration [Tmax] of Betamethasone 17-propionate at Week 4
Time to maximum plasma drug concentration \[Tmax\] of the metabolite of BDP, betamethasone 17-propionate measured at Week 4.
Time frame: Week 4