A Clinical Trial Evaluating Efficacy and Safety of MC2-01 Cream
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|