Back to resultsA Clinical Trial Evaluating Efficacy and Safety of MC2-01 Cream
Primary Purpose
Psoriasis Vulgaris
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
MC2-01 cream
Cal/BDP combination
Cream vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis Vulgaris
Eligibility Criteria
Inclusion Criteria:
- Provided written informed consent
- Generally healthy males or non-pregnant females, of any race or ethnicity, who are at least 18 years of age at the time of screening
- Have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6 months duration that involves the trunk and/or limbs that is amenable to topical treatment with a maximum of 100 g of trial medication per week
- Have a PGA of disease severity of mild or moderate on the body (trunk and/or limbs)
- An mPASI score of at least 2
- Have a treatment area involving 2- 30% of the body surface area (BSA)
Exclusion Criteria:
- Current diagnosis of unstable forms of psoriasis
- Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis vulgaris
- Presence of pigmentation, extensive scarring, pigmented lesions or sunburn in the treatment areas
- Planned exposure to either natural or artificial sunlight
- History of hypersensitivity to any component of the test product or reference product
- Current or past history of hypercalcemia, vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders
- Systemic treatment with biological therapies
- Use of systemic treatments that suppress the immune system and other systemic chemotherapeutic antineoplastic therapy within 4 weeks prior to the baseline visit and during the trial
- Use of phototherapy within 4 weeks prior to Visit 1/Baseline and during the trial;
- Use of topical treatments, except for emollients and non-medicated shampoos, with a possible effect on psoriasis within 2 weeks prior to Visit 1/Baseline
- Clinical signs of skin infection with bacteria, viruses, or fungi
- Known Human Immunodeficiency Virus (HIV) infection
- Any chronic or acute medical condition that may pose a risk to the safety of the subject, or may interfere with the assessment of safety or efficacy in this trial
Sites / Locations
- Henry Ford Hospital
- Minnesota Clinical Study Center
- Richard Herdener, MD
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
MC2-01 Cream
Cal/BDP combination
Cream vehicle
Arm Description
MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks
Calcipotriene/betamethasone (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%). One application daily for 8 weeks.
One application daily for 8 weeks.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Percentage Change in mPASI Score
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03308799
Brief Title
A Clinical Trial Evaluating Efficacy and Safety of MC2-01 Cream
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 3, 2017 (Actual)
Primary Completion Date
June 8, 2018 (Actual)
Study Completion Date
June 8, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MC2 Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
794 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MC2-01 Cream
Arm Type
Experimental
Arm Description
MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks
Arm Title
Cal/BDP combination
Arm Type
Active Comparator
Arm Description
Calcipotriene/betamethasone (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%). One application daily for 8 weeks.
Arm Title
Cream vehicle
Arm Type
Placebo Comparator
Arm Description
One application daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
MC2-01 cream
Intervention Description
MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream
Intervention Type
Drug
Intervention Name(s)
Cal/BDP combination
Intervention Description
calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%
Intervention Type
Drug
Intervention Name(s)
Cream vehicle
Intervention Description
Vehicle Cream
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Percentage Change in mPASI Score
Description
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
Time Frame
Baseline and 8 weeks
Title
Psoriasis Treatment Convenience Scale
Description
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
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provided written informed consent
Generally healthy males or non-pregnant females, of any race or ethnicity, who are at least 18 years of age at the time of screening
Have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6 months duration that involves the trunk and/or limbs that is amenable to topical treatment with a maximum of 100 g of trial medication per week
Have a PGA of disease severity of mild or moderate on the body (trunk and/or limbs)
An mPASI score of at least 2
Have a treatment area involving 2- 30% of the body surface area (BSA)
Exclusion Criteria:
Current diagnosis of unstable forms of psoriasis
Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis vulgaris
Presence of pigmentation, extensive scarring, pigmented lesions or sunburn in the treatment areas
Planned exposure to either natural or artificial sunlight
History of hypersensitivity to any component of the test product or reference product
Current or past history of hypercalcemia, vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders
Systemic treatment with biological therapies
Use of systemic treatments that suppress the immune system and other systemic chemotherapeutic antineoplastic therapy within 4 weeks prior to the baseline visit and during the trial
Use of phototherapy within 4 weeks prior to Visit 1/Baseline and during the trial;
Use of topical treatments, except for emollients and non-medicated shampoos, with a possible effect on psoriasis within 2 weeks prior to Visit 1/Baseline
Clinical signs of skin infection with bacteria, viruses, or fungi
Known Human Immunodeficiency Virus (HIV) infection
Any chronic or acute medical condition that may pose a risk to the safety of the subject, or may interfere with the assessment of safety or efficacy in this trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda S. Gold, MD
Organizational Affiliation
Henry Ford Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Richard Herdener, MD
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34648147
Citation
Feldman SR, Praestegaard M, Andreasen AH, Selmer J, Holm-Larsen T. Validation of the Self-Reported Psoriasis Treatment Convenience Scale (PTCS). Dermatol Ther (Heidelb). 2021 Dec;11(6):2077-2088. doi: 10.1007/s13555-021-00626-5. Epub 2021 Oct 14.
Results Reference
derived
PubMed Identifier
33852251
Citation
Stein Gold L, Green LJ, Dhawan S, Vestbjerg B, Praestegaard M, Selmer J. A Phase 3, Randomized Trial Demonstrating the Improved Efficacy and Patient Acceptability of Fixed Dose Calcipotriene and Betamethasone Dipropionate Cream. J Drugs Dermatol. 2021 Apr 1;20(4):420-425. doi: 10.36849/JDD.2021.5653.
Results Reference
derived
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A Clinical Trial Evaluating Efficacy and Safety of MC2-01 Cream
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