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

Phase 3

Completed

Conditions: Psoriasis Vulgaris

Interventions: Drug: Cal/BDP combination
Drug: Cream vehicle
Drug: MC2-01 cream

Registration Number: NCT03308799

Lead Sponsor: MC2 Therapeutics

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 794

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cal/BDP combination	Cal/BDP combination	Calcipotriene/betamethasone (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%). One application daily for 8 weeks.
Cream vehicle	Cream vehicle	One application daily for 8 weeks.
MC2-01 Cream	MC2-01 cream	MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
Percentage Change in mPASI Score	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	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

Trial Locations

Locations (3): Henry Ford Hospital
🇺🇸
Detroit, Michigan, United States
Minnesota Clinical Study Center
🇺🇸
Fridley, Minnesota, United States
Richard Herdener, MD
🇺🇸
Spokane, Washington, United States