Title
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
Phase
Phase 3Lead Sponsor
MC2 TherapeuticsStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Psoriasis VulgarisIntervention/Treatment
MC2-01 cream [betamethasone (23732), calcipotriene (110605)] Cal/BDP combination [calcipotriene (110605), betamethasone (23732)] ...Study Participants
794This 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.
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.
MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream
calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%
Vehicle Cream
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.
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
| Event Type | Organ System | Event Term | MC2-01 Cream | CAL/BDP Combination | Vehicle |
|---|
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.
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
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
