NCT03462927

A Maximal Use Trial Evaluating the Pharmacokinetic Profile of MC2-01 Cream

A Randomised, Open-label, Maximal Use Trial, Evaluating the Pharmacokinetic Profile of Active Ingredients and Their Metabolites After Application of MC2-01 Cream Compared With Active Comparator in Subjects With Extensive Psoriasis Vulgaris

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: MC2 Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
DRUG	MC2-01 Cream	MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%)
DRUG	CAL/BDP combination	Calcipotriene/betamethasone (calcipotriene/ betamethasone dipropionate, w/w 0.005%/0.064%)

Timeline

• Start date: 2018-02-08
• Primary completion: 2018-08-04
• Completion: 2018-08-04
• First posted: 2018-03-13
• Last updated: 2019-12-24
• Results posted: 2019-12-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study