NCT03802344

This Trial is a Randomised, Multicentre, Investigator-blind, Vehicle and Comparator-controlled, Parallel-group Trial With the Purpose of Evaluation Efficacy, Safety and Convenience of the MC2-01 Cream

A Randomised, Multicentre, Investigator-Blind, Parallel-Group Trial to Evaluate the Efficacy and Safety of MC2-01 Cream Compared to Vehicle and Active Comparator in Subjects With Mild-to-Moderate Psoriasis Vulgaris

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 498 (actual)
• Sponsor: MC2 Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is a randomized, investigator-blind, multicentre, vehicle- and comparator-controlled, parallel-group trial with the purpose of evaluating the efficacy, safety and convenience of the MC2-01 cream.

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 in daily routines. In this trial, the MC2-01 cream will be compared to a marketed product CAL/BDP combination and vehicle. The purpose of the trial is to compare the clinical efficacy, safety, and convenience of this cream to the marketed product. The trial will include a 8-week treatment period.

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
DRUG	MC2-01 cream	MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream
DRUG	Cal/BDP combination	Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%
DRUG	Vehicle	Vehicle cream

Timeline

• Start date: 2018-12-12
• Primary completion: 2019-10-02
• Completion: 2019-10-02
• First posted: 2019-01-14
• Last updated: 2020-12-16
• Results posted: 2020-11-27

Locations

2 sites across 2 countries: Czechia, Germany

Regulatory

• FDA-regulated drug study