A Clinical Trial Evaluating Efficacy and Safety of MC2-01 Cream
Status: | Completed |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 7/27/2018 |
Start Date: | October 3, 2017 |
End Date: | June 8, 2018 |
A Randomised, Multicentre, Investigator-Blind, Parallel-Group Trial to Evaluate the Efficacy and Safety of MC2-01 Cream Compared to Vehicle and Active Comparator in Subjects With Mild-to-Moderate Psoriasis Vulgaris
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.
comparator-controlled, parallel-group trial with the purpose of evaluating efficacy, safety
and convenience of the MC2-01 cream.
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 cream will be compared to a marketed product CAL/BDP combination and
vehicle. The purpose of the trial is to compare the clinical efficacy, safety, and
convenience of this cream to the marketed product. The trial will include a 8-week treatment
period.
skin leaving it nicely moisturized allowing patients to move on in daily routines. In this
trial, the MC2-01 cream will be compared to a marketed product CAL/BDP combination and
vehicle. The purpose of the trial is to compare the clinical efficacy, safety, and
convenience of this cream to the marketed product. The trial will include a 8-week treatment
period.
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
We found this trial at
3
sites
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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