A Maximal Use Trial Evaluating the Pharmacokinetic Profile of MC2-01 Cream in Adolescent Subjects
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Intervention: MC2-01 cream
Intervention description: MC2-01 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 12 Years
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      This is a phase 2, open-label, single-group, multicentre trial in which the investigational
      product, MC2-01 cream, is investigated in adolescent subjects (age 12 to 16 years, 11 months)
      with clinically diagnosed extensive psoriasis vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The parent(s), or legal guardian(s) (according to national law) have provided written
             informed consent following their receipt of verbal and written information about the
             trial

          -  The subject (according to national law) has provided written assent to the trial
             following their receipt of verbal and written information about the trial

          -  Generally healthy males or non-pregnant females, of any race or ethnicity, who are
             between 12 to 16 years, 11-month-old at Screening Visit 1 (SV1)

          -  At Visit 1/Day 0, have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris)
             of at least 6 months duration involving body (trunk and/or limbs), with or without
             scalp

          -  Have a treatment area between 10% and 30% of the Body Surface Area (BSA) on the body
             (trunk and/or limbs) and scalp, excluding psoriatic lesions on the face, genitals, and
             intertriginous areas, at Visit 1/Day 0

          -  Have a Physician's Global Assessment (PGA) of at least moderate severity on the
             treatment area

          -  A normal HPA axis function including a serum cortisol concentration above 4,5 mcg/dl
             before ACTH-challenge and equal or above 18 mcg/dl 30 minutes after ACTH challenge, at
             Screening Visit 2 (SV2)

          -  A serum albumin-corrected calcium below the upper reference limit at SV2

        Exclusion Criteria:

          -  Have a current diagnosis of unstable forms of psoriasis, including erythrodermic or
             pustular psoriasis

          -  Other inflammatory skin disease in the treatment area that may confound the evaluation
             of the psoriasis vulgaris

          -  Presence of infections in the treatment area or skin manifestations or atrophic skin,
             atrophic striae, skin vein fragility, ichthyosis, acne vulgaris, acne rosacea,
             rosacea, ulcers and wounds in the treatment area

          -  Presence of pigmentation, extensive scarring, pigmented lesions or sunburn in the
             treatment areas, which could interfere with the rating of efficacy parameters

          -  Planned excessive or prolonged exposure to either natural or artificial sunlight

          -  Use of phototherapy (psoralen + ultraviolet A radiation and ultraviolet B radiation
             within 4 weeks prior to SV2 and during the trial

          -  Current or past history of disorders of calcium metabolism associated with
             hypercalcemia, vitamin D toxicity, severe renal insufficiency, or severe hepatic
             disorders

          -  Oral calcium supplements, vitamin D supplements, bisphosphonates or calcitonin within
             4 weeks prior to SV2

          -  Planned initiation of, or changes to concomitant medication that could affect calcium
             metabolism during the trial;

          -  Planned initiation of, or changes to, concomitant estrogen therapy during the trial

          -  Strong systemic cytochrome P450 3A4 (CYP 3A4) inhibitors or inducers within 4 weeks
             prior to SV2 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 SV2 and during the trial

          -  Systemic treatment with biological therapies, with a possible effect on psoriasis
             vulgaris within the following time period prior to SV2 and during the trial

          -  Initiation of, or expected changes to, concomitant medication that may affect
             psoriasis during the trial

          -  Any of the following conditions, whether known or suspected; Clinically diagnosed
             depression where the subject is in current treatment with medication approved for
             treatment of depression; Endocrine disorders known to affect cortisol levels or HPA
             axis integrity; Non-nocturnal sleep patterns

          -  Use of systemic medication that suppresses the immune system and other systemic
             chemotherapeutic antineoplastic therapy within 4 weeks prior to the SV2 and during the
             trial

          -  Use of live vaccines 4 weeks before SV2 and during the trial

          -  Have clinical signs of skin infection with bacteria, viruses, or fungi

          -  Known human immunodeficiency virus (HIV) infection, active hepatitis B or hepatitis C

          -  Known or suspected of hypersensitivity to any component of the test product

          -  Known allergic asthma, serious allergies or allergies where recurrent acute or chronic
             treatment is necessary

          -  Have any chronic or acute medical condition that, in the opinion of the investigator,
             may pose a risk to the safety of the subject, or may interfere with the assessment of
             safety or efficacy in this trial

          -  Require the use of any concomitant medication that, in the investigator's opinion, has
             the potential to cause an adverse effect when given with the Investigational Product
             (IP) or will interfere with the interpretation of the trial results

          -  Subject with known abnormal reduction in muscle mass, as judged by the investigator