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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03308799
Recruitment Status : Completed
First Posted : October 13, 2017
Last Update Posted : July 25, 2018
Information provided by (Responsible Party):
Drug Delivery Solutions Ltd. (part of MC2 Therapeutics)

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 cream.

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: MC2-01 cream Drug: Cal/BDP combination Drug: Cream vehicle Phase 3

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 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 796 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 3, 2017
Actual Primary Completion Date : June 8, 2018
Actual Study Completion Date : June 8, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: MC2-01 Cream
MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks
Drug: MC2-01 cream
MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream

Active Comparator: Cal/BDP combination
Calcipotriene/betamethasone (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%). One application daily for 8 weeks.
Drug: Cal/BDP combination
calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%

Placebo Comparator: Cream vehicle
One application daily for 8 weeks.
Drug: Cream vehicle
Vehicle Cream

Primary Outcome Measures :
  1. PGA [ Time Frame: 8 weeks ]
    Physicians Global Assessment

Secondary Outcome Measures :
  1. mPASI [ Time Frame: 8 weeks ]
    modified PASI scoring system (excluding scalp, face, and flexures)

  2. Psoriasis Treatment Convenience Scale [ Time Frame: 8 weeks ]
    Subject assessment of treatment convenience using a Psoriasis Treatment Convenience Scale

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03308799

United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
United States, Washington
Richard Herdener, MD
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Drug Delivery Solutions Ltd. (part of MC2 Therapeutics)
Principal Investigator: Linda S. Gold, MD Henry Ford Health System

Responsible Party: Drug Delivery Solutions Ltd. (part of MC2 Therapeutics) Identifier: NCT03308799     History of Changes
Other Study ID Numbers: MC2-01-C2
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Betamethasone benzoate
Betamethasone Valerate
Betamethasone sodium phosphate
Skin Diseases, Papulosquamous
Skin Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents