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.
|Psoriasis Vulgaris||Drug: MC2-01 cream Drug: Cal/BDP combination Drug: Cream vehicle||Phase 3|
|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
|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)|
| 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|
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.