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
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Intervention: MC2-01 cream; Cal/BDP combination; Vehicle
Intervention description: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream; Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%; Vehicle cream
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 498.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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