A Clinical Trial Evaluating Efficacy and Safety of MC2-01 Cream

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Psoriasis Vulgaris

Intervention / Treatment
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* Drug: MC2-01 cream
* Drug: Cal/BDP combination
* Drug: Cream vehicle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MC2-01 Cream<br>MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks | Drug: MC2-01 cream<br>* MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream<br>|
| Active Comparator: Cal/BDP combination<br>Calcipotriene/betamethasone (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%). One application daily for 8 weeks. | Drug: Cal/BDP combination<br>* calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%<br>|
| Placebo Comparator: Cream vehicle<br>One application daily for 8 weeks. | Drug: Cream vehicle<br>* Vehicle Cream<br>|

What is the study measuring?
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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 | 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 | 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 | 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 |