- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03308799
A Clinical Trial Evaluating Efficacy and Safety of MC2-01 Cream
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Henry Ford Hospital
-
-
Minnesota
-
Fridley, Minnesota, United States, 55432
- Minnesota Clinical Study Center
-
-
Washington
-
Spokane, Washington, United States, 99202
- Richard Herdener, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MC2-01 Cream
MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%)
cream.
One application daily for 8 weeks
|
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.
|
calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%
|
Placebo Comparator: Cream vehicle
One application daily for 8 weeks.
|
Vehicle Cream
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Baseline and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
Baseline and 8 weeks
|
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 |
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Linda S. Gold, MD, Henry Ford Health System
Publications and helpful links
General Publications
- Feldman SR, Præstegaard 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MC2-01-C2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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