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

Use our guide to learn which trials are right for you!

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.

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.

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
Fridley, Minnesota 55432
?
mi
from
Fridley, MN
Click here to add this to my saved trials
2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
510 South Cowley Street
Spokane, Washington 99202
Phone: 509-381-1972
?
mi
from
Spokane, WA
Click here to add this to my saved trials