A Maximal Use Trial Evaluating the Pharmacokinetic Profile of MC2-01 Cream

Completed · Phase 2

Conditions studied: Psoriasis Vulgaris

In brief

This is a phase 2, randomised, open-label, parallel-group, multicentre trial in which MC2-01 cream and calcipotriene \[CAL\]/betamethasone \[BDP\] ointment (comparator) is investigated in subjects with clinically diagnosed extensive psoriasis vulgaris.

Key facts

Study ID

NCT03462927

Run by

MC2 Therapeutics

People needed

63

Starts

2018-02-08

Expected to finish

2018-08-04

Last updated by the study team

2019-12-24

Who can join

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

You may qualify if…

• 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.
• At Visit 1/Day 0, have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6 months duration involving scalp and body (trunk and/or limbs) that is amenable to topical treatment with a maximum of 100 g of trial medication per week.
• Have a Physician's Global Assessment [PGA] of severity of at least moderate on the trunk, limbs and/or scalp, at Visit 1/Day 0.
• Have a treatment area between 20% and 30% of the body surface area [BSA] on the trunk, limbs and/or scalp, excluding psoriatic lesions on the face, genitals, and intertriginous areas, at Visit 1/Day 0.

You may not qualify if…

• Current diagnosis of unstable forms of psoriasis
• Other inflammatory skin disease in the treatment area
• Pigmentation, extensive scarring, pigmented lesions or sunburn in the treatment areas
• Planned exposure to natural or artificial sunlight
• Phototherapy and ultraviolet B radiation within 4 weeks prior to Visit 1/Baseline and during the trial;
• Current or past history of 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 Visit 1/Day 0 during the trial period.
• 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 within 4 weeks prior to Vist 1/Day 0 and during the trial period;
• Use of topical treatments, except for emollients and non-medicated shampoos, with a possible effect on psoriasis within 2 weeks prior to Visit 1/Day 0 and during the trial period;
• Systemic treatment with biological therapies
• Initiation of, or expected changes to, concomitant medication that may affect psoriasis during the trial period;
• Depression and endocrine disorders known to affect cortisol levels or HPA axis integrity, non-nocturnal sleep patterns
• Systemic medication that suppresses the immune system within 4 weeks prior to the Visit 1/Day 0 and during the trial period;
• Clinical signs of skin infection with bacteria, viruses, or fungi;
• Known human immunodeficiency virus [HIV] infection;
• Known or suspected of hypersensitivity to any component of the test product or reference product;
• 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

• Lenus Research and Medical Group — Sweetwater, Florida, United States

Full record on ClinicalTrials.gov

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