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

MC2 Therapeutics

Status and phase: Completed; Phase 3

Conditions: Psoriasis Vulgaris

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03308799

MC2-01-C2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 794 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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794 participants in 3 patient groups, including a placebo group

MC2-01 Cream

Experimental group

Description:

MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks

Treatment:

Drug: MC2-01 cream

Cal/BDP combination

Active Comparator group

Description:

Calcipotriene/betamethasone (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%). One application daily for 8 weeks.

Treatment:

Drug: Cal/BDP combination

Cream vehicle

Placebo Comparator group

Description:

One application daily for 8 weeks.

Treatment:

Drug: Cream vehicle