This Trial is a Randomised, Multicentre, Investigator-blind, Vehicle and Comparator-controlled, Parallel-group Trial With the Purpose of Evaluation Efficacy, Safety and Convenience of the MC2-01 Cream

MC2 Therapeutics

Status and phase: Completed; Phase 3

Conditions: Psoriasis Vulgaris

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03802344

MC2-01-C7

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 the 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: 498 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have 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 body (trunk and/or limbs) that is amenable to topical treatment with a maximum of 15 g of trial medication per day
• Have a PGA of disease severity of mild or moderate on the body (trunk and/or limbs)
• Have an mPASI score of at least 3
• Have a treatment area involving 2-30% of the body (trunk and/or limbs). For subjects with scalp psoriasis included in the treatment area, the total treatment area on body and scalp must not exceed 30%.

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 excessive or prolonged 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 Visit 1/Baseline 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
• Presence of infections in the treatment area (bacteria, viruses, parasites or fungi) or skin manifestations of atrophic skin, atrophic striae, skin vein fragility, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers and wound in the treatment area
• Known Human Immunodeficiency Virus (HIV) infection
• Have 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
• Initiation of, or expected changes to, concomitant medication that may affect psoriasis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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498 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%) cream. One application daily for 8 weeks

Treatment:

Drug: Cal/BDP combination

Vehicle

Placebo Comparator group

Description:

One application daily for 8 weeks

Treatment:

Drug: Vehicle