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

Completed · Phase 3

Conditions studied: Psoriasis Vulgaris

In brief

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.

Key facts

Study ID

NCT03308799

Run by

MC2 Therapeutics

People needed

794

Starts

2017-10-03

Expected to finish

2018-06-08

Last updated by the study team

2024-12-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Henry Ford Hospital — Detroit, Michigan, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• Richard Herdener, MD — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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