Status:
COMPLETED
A Clinical Trial Evaluating Efficacy and Safety of MC2-01 Cream
Lead Sponsor:
MC2 Therapeutics
Conditions:
Psoriasis Vulgaris
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 crea...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2018
Estimated Enrollment :
794 Patients enrolled
Trial Details
Trial ID
NCT03308799
Start Date
October 3 2017
End Date
June 8 2018
Last Update
December 9 2024
Active Locations (3)
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1
Henry Ford Hospital
Detroit, Michigan, United States, 48202
2
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
3
Richard Herdener, MD
Spokane, Washington, United States, 99202