A Clinical Trial Evaluating Efficacy and Safety of MC2-01 Cream
|ClinicalTrials.gov Identifier: NCT03308799|
Recruitment Status : Completed
First Posted : October 13, 2017
Results First Posted : October 29, 2019
Last Update Posted : October 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis Vulgaris||Drug: MC2-01 cream Drug: Cal/BDP combination Drug: Cream vehicle||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||794 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Actual Study Start Date :||October 3, 2017|
|Actual Primary Completion Date :||June 8, 2018|
|Actual Study Completion Date :||June 8, 2018|
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
- Number of Participants With a Decrease in the Physicians Global Assessment (PGA) Score of Minimum 2 Points on a Scale From 0-4 From Baseline to Week 8 [ Time Frame: Baseline and 8 weeks ]
Psoriasis treatment success rate is measured at week 8 by the use of a Physician Global Assessment (PGA) score. Success is defined as a decrease from Baseline of minimum 2 point on a scale from 0 - 4, where: 0 = Clear; 1 = Almost clear; 2 = Mild Plaque thickening; 3 = Moderate Plaque thickening, 4 = Severe Plaque thickening.
The number of participants referred in the data sets are the number of participants, who achieved a successful treatment success.
- Percentage Change in mPASI Score [ Time Frame: Baseline and 8 weeks ]
The extent and severity of the participant's psoriasis is assessed using a modified PASI scoring system (minus scalp, face, and flexures) at each 3 areas (arms, trunk and legs) using a scale from 0 - 6, where 0 = no psoriasis involvement and 6 = 90-100% involvement.
The severity is assessed at each 3 areas (arms, trunk and legs) for each of the sign redness, thickness and scaliness using a scale from 0 - 4, where 0 represents none and 4 represents very severe.
The mPASI score is calculated from the individual scores by use of the following equation:
Arms 0.2 (Redness + Thickness + Scaliness) E = X Trunk 0.3 (Redness + Thickness + Scaliness) E = Y Legs 0.4 (Redness + Thickness + Scaliness) E = Z
The sum of X + Y + Z = m-PASI score resulting in a minimum score of 0 and a maximum score (worst possible) of 64.8.
The percent change in mPASI score is defined as the Baseline minus the Week 8 divided by Baseline score multiplied by 100
- Psoriasis Treatment Convenience Scale [ Time Frame: 8 weeks ]
Subject assessment of treatment convenience using a Psoriasis Treatment Convenience Scale is defined as a sum of questions 1-5, where each question is scored on a scale from 1-10.
How easy was the treatment to apply to the skin? "Very difficult" is 1 and "Very easy" is 10 How greasy was the treatment when applying it to the skin? "Very greasy" is 1 and "Not greasy" is 10 How moisturised did your skin feel after applying the treatment? "Not moisturized" is 1 and "Very moisturized" is 10 How greasy did your skin feel after applying the treatment? "Very greasy" is 1 and "Not greasy" is 10 How much did treating your skin disrupt your daily routine? "Very disturbing" is 1 and "Not disturbing" is 10
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308799
|United States, Michigan|
|Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|United States, Minnesota|
|Minnesota Clinical Study Center|
|Fridley, Minnesota, United States, 55432|
|United States, Washington|
|Richard Herdener, MD|
|Spokane, Washington, United States, 99202|
|Principal Investigator:||Linda S. Gold, MD||Henry Ford Health System|