Home / Psoriasis / A Clinical Trial Evaluating Efficacy and Safety of MC2-01 Cream

A Clinical Trial Evaluating Efficacy and Safety of MC2-01 Cream


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

Condition Intervention Phase
Psoriasis Vulgaris Drug: MC2-01 cream Drug: Cal/BDP combination Drug: Cream vehicle Phase 3

Study Type: Interventional
Study Design:Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: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

Resource links provided by NLM:

Further study details as provided by Drug Delivery Solutions Ltd. (part of MC2 Therapeutics):

Primary Outcome Measures:

  • PGA [ Time Frame: 8 weeks ]
    Physicians Global Assessment

Secondary Outcome Measures:

  • mPASI [ Time Frame: 8 weeks ]
    modified PASI scoring system (excluding scalp, face, and flexures)

  • Psoriasis Treatment Convenience Scale [ Time Frame: 8 weeks ]
    Subject assessment of treatment convenience using a Psoriasis Treatment Convenience Scale

Estimated Enrollment:791
Actual Study Start Date:October 3, 2017
Estimated Study Completion Date:June 15, 2018
Estimated Primary Completion Date:May 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MC2-01 Cream

MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks
Drug: MC2-01 cream

MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream
Active Comparator: Cal/BDP combination

Calcipotriene/betamethasone (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%). One application daily for 8 weeks.
Drug: Cal/BDP combination

calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%
Placebo Comparator: Cream vehicle

One application daily for 8 weeks.
Drug: Cream vehicle

Vehicle 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.


Check Also

Risankizumab Therapy Versus Placebo for Subjects With Psoriasis in the Russian Federation (IMMPRESS)

Study Description Go to  Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Brief Summary: The purpose of this study is to assess the safety and efficacy of risankizumab compared to placebo in subjects with moderate to severe chronic plaque psoriasis in the Russian Federation. Condition …

Leave a Reply

Your email address will not be published. Required fields are marked *