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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.
 
ClinicalTrials.gov Identifier: NCT03308799
Recruitment Status : Completed
First Posted : October 13, 2017
Results First Posted : October 29, 2019
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 794 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. Number of Participants With a Decrease in the Physicians Global Assessment (PGA) Score of Minimum 2 Points on a Scale From 0-4 From Baseline to Week 8 [ Time Frame: Baseline and 8 weeks ]

    Psoriasis treatment success rate is measured at week 8 by the use of a Physician Global Assessment (PGA) score. Success is defined as a decrease from Baseline of minimum 2 point on a scale from 0 - 4, where: 0 = Clear; 1 = Almost clear; 2 = Mild Plaque thickening; 3 = Moderate Plaque thickening, 4 = Severe Plaque thickening.

    The number of participants referred in the data sets are the number of participants, who achieved a successful treatment success.



Secondary Outcome Measures :
  1. Percentage Change in mPASI Score [ Time Frame: Baseline and 8 weeks ]

    The extent and severity of the participant's psoriasis is assessed using a modified PASI scoring system (minus scalp, face, and flexures) at each 3 areas (arms, trunk and legs) using a scale from 0 - 6, where 0 = no psoriasis involvement and 6 = 90-100% involvement.

    The severity is assessed at each 3 areas (arms, trunk and legs) for each of the sign redness, thickness and scaliness using a scale from 0 - 4, where 0 represents none and 4 represents very severe.

    The mPASI score is calculated from the individual scores by use of the following equation:

    Arms 0.2 (Redness + Thickness + Scaliness) E = X Trunk 0.3 (Redness + Thickness + Scaliness) E = Y Legs 0.4 (Redness + Thickness + Scaliness) E = Z

    The sum of X + Y + Z = m-PASI score resulting in a minimum score of 0 and a maximum score (worst possible) of 64.8.

    The percent change in mPASI score is defined as the Baseline minus the Week 8 divided by Baseline score multiplied by 100


  2. Psoriasis Treatment Convenience Scale [ Time Frame: 8 weeks ]

    Subject assessment of treatment convenience using a Psoriasis Treatment Convenience Scale is defined as a sum of questions 1-5, where each question is scored on a scale from 1-10.

    How easy was the treatment to apply to the skin? "Very difficult" is 1 and "Very easy" is 10 How greasy was the treatment when applying it to the skin? "Very greasy" is 1 and "Not greasy" is 10 How moisturised did your skin feel after applying the treatment? "Not moisturized" is 1 and "Very moisturized" is 10 How greasy did your skin feel after applying the treatment? "Very greasy" is 1 and "Not greasy" is 10 How much did treating your skin disrupt your daily routine? "Very disturbing" is 1 and "Not disturbing" is 10




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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 ClinicalTrials.gov identifier (NCT number): NCT03308799


Locations
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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
MC2 Therapeutics
Investigators
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Principal Investigator: Linda S. Gold, MD Henry Ford Health System
  Study Documents (Full-Text)

Documents provided by MC2 Therapeutics:
Study Protocol  [PDF] February 27, 2018
Statistical Analysis Plan  [PDF] July 5, 2018


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Responsible Party: MC2 Therapeutics
ClinicalTrials.gov Identifier: NCT03308799    
Other Study ID Numbers: MC2-01-C2
First Posted: October 13, 2017    Key Record Dates
Results First Posted: October 29, 2019
Last Update Posted: October 29, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases