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

• Status: Completed
• Trial end date: 2018-06-08
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Drug Delivery Solutions Ltd. (part of MC2 Therapeutics); MC2 Therapeutics
• Treatments: Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Calcipotriene

Criteria

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