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

Psoriasis Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03308799
• Other study ID #: MC2-01-C2
• Status: Completed
• Phase: Phase 3
• Start date: October 3, 2017
• Est. completion date: June 8, 2018

Study information

• Verified date: August 2019
• Source: MC2 Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 794
• Est. completion date: June 8, 2018
• Est. primary completion date: June 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• MC2-01 cream
MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream
• Cal/BDP combination
calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%
• Cream vehicle
Vehicle Cream

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Richard Herdener, MD	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
MC2 Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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