Clinical trial NCT03308799: A Clinical Trial Evaluating Efficacy and Safety of MC2-01 Cream
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis Vulgaris
Lead sponsor: MC2 Therapeutics
Sponsor class: INDUSTRY
First posted: 2017-10-13
Enrollment: 794
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Percentage Change in mPASI Score
timeFrame: Baseline and 8 weeks
measure: Psoriasis Treatment Convenience Scale
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Spokane
country: United States
facility: Richard Herdener, MD
state: Washington
Study officials:
affiliation: Henry Ford Health System
name: Linda S. Gold, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feldman SR, Praestegaard 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.
citation: 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.