This is a phase 2, randomised, open-label, parallel-group, multicentre trial in which MC2-01 cream and calcipotriene \[CAL\]/betamethasone \[BDP\] ointment (comparator) is investigated in subjects 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, the MC2-01 cream will be compared to a marketed calcipotriene \[CAL\]/betamethasone dipropionate \[BDP\] ointment. The purpose of the trial, is to determine the pharmacokinetic parameters of MC2-01 cream and the comparator under maximum use conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%)
Calcipotriene/betamethasone (calcipotriene/ betamethasone dipropionate, w/w 0.005%/0.064%)
Lenus Research and Medical Group
Sweetwater, Florida, United States
Maximum Plasma Concentration (Cmax) of the Active Ingredient Calcipotriene
Geometric Mean for Maximum Plasma Concentration \[Cmax\] for the active ingredient Calcipotriene. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose
Time frame: Week 4
Maximum Plasma Concentration (Cmax) of the Active Ingredient Calcipotriene
Geometric Mean for Maximum Plasma Concentration \[Cmax\] for the active ingredient Calcipotriene. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose
Time frame: Week 8
Maximum Plasma Concentration (Cmax) of Active Ingredient Betamethasone Dipropionate
Geometric Mean for Maximum Plasma Concentration \[Cmax\] for the active ingredient Betamethasone Dipropionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose
Time frame: Week 4
Maximum Plasma Concentration (Cmax) of Active Ingredient Betamethasone Dipropionate
Geometric Mean for Maximum Plasma Concentration \[Cmax\] for the active ingredient Betamethasone Dipropionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose
Time frame: Week 8
Maximum Plasma Concentration (Cmax) of the Metabolite MC1080
Geometric Mean for Maximum Plasma Concentration \[Cmax\] for the metabolite MC1080. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose
Time frame: Week 4
Maximum Plasma Concentration (Cmax) of the Metabolite MC1080
Geometric Mean for Maximum Plasma Concentration \[Cmax\] for the metabolite MC1080. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose
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Time frame: Week 8
Maximum Plasma Concentration (Cmax) of Metabolite Betamethasone 17-propionate
Geometric Mean for Maximum Plasma Concentration \[Cmax\] for the metabolite Betamethasone 17-propionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose
Time frame: Week 4
Maximum Plasma Concentration (Cmax) of Metabolite Betamethasone 17-propionate
Geometric Mean for Maximum Plasma Concentration \[Cmax\] for the metabolite Betamethasone 17-propionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose
Time frame: Week 8
Number of Subjects With Hypothalamic-pituitary-adrenal [HPA] Suppression After 4 Weeks of Treatment
The HPA axis evaluation is based on an Adrenocorticotropic hormone \[ACTH\] challenge test, defined by a 30 minutes ACTH stimulated cortisol value. Only subject with no HPA suppression at baseline were included in the analysis. The outcome measure lists the number of subjects with HPA suppression 30 minutes after ACTH challenge
Time frame: Week 4
Number of Subjects With Hypothalamic-pituitary-adrenal [HPA] Suppression After 8 Weeks of Treatment
The HPA challenge test were only performed on subjects that were assigned to the MC2-01 cream group. Out of a total of 32 subjects, 5 subjects were excluded from the analysis as they had HPA suppression at baseline
Time frame: Week 8
Calcium Metabolism Evaluation in Albumin-corrected Serum Calcium
Changes from baseline of albumin-corrected serum calcium \[mmol/L\]
Time frame: Baseline and week 4
Calcium Metabolism Evaluation in Albumin-corrected Serum Calcium
Changes from baseline in albumin-corrected serum calcium \[mmol/L\]
Time frame: Baseline and week 8
Calcium Metabolism Evaluation of 24-hour Urinary Calcium Excretion
Changes from baseline of 24-hour urinary calcium excretion \[mmol/day\]
Time frame: Baseline and week 4
Calcium Metabolism Evaluation of 24-hour Urinary Calcium Excretion
Changes from baseline of 24-hour urinary calcium excretion \[mmol/day\]
Time frame: Baseline and week 8
Calcium Metabolism Evaluation of the Ratio of Urinary Calcium to Creatinine
Changes from baseline in ratio of urinary calcium to creatinine defined as urinary calcium (mmol)/creatinine (g)
Time frame: Baseline and week 4
Calcium Metabolism Evaluation of the Ratio of Urinary Calcium to Creatinine
Changes from baseline in ratio of urinary calcium to creatinine defined as urinary calcium (mmol)/creatinine (g)
Time frame: Baseline and week 8