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

  Purpose

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.

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