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This Trial is a Randomised, Multicentre, Investigator-blind, Vehicle and Comparator-controlled, Parallel-group Trial With the Purpose of Evaluation Efficacy, Safety and Convenience of the 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: NCT03802344
Recruitment Status : Completed
First Posted : January 14, 2019
Last Update Posted : October 18, 2019
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 the 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: 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 : 498 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
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 : December 12, 2018
Actual Primary Completion Date : October 2, 2019
Actual Study Completion Date : October 2, 2019

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%) cream. One application daily for 8 weeks
Drug: Cal/BDP combination
Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%

Placebo Comparator: Vehicle
One application daily for 8 weeks
Drug: Vehicle
Vehicle cream

Primary Outcome Measures :
  1. mPASI [ Time Frame: 8 Weeks ]
    Percentage change from baseline in mPASI (modified Psoriasis Area and Severity Index) on trunk and/or limbs

Secondary Outcome Measures :
  1. Physicians Global Assessment (PGA) [ Time Frame: 8 Weeks ]
    PGA measures the investigator's impression of the disease by assessing the psoriasis lesions on the subject's skin and rating it, using a defined, 5-point, static scale (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate or 4 = severe). Two individual assessments will be made for the body and the scalp. The PGA will represent the average lesion severity at the time of the evaluation

  2. The Psoriasis Treatment Convenience Scale (PTCS) [ Time Frame: 8 Weeks ]
    PTCS measures the impact and convenience of the treatment. The scale consists of 6 disease-specific questions, witch individually will be rated on a 1-10 points scale where a score of 1 represents the lowest satisfactory response with the treatment and 10 represents the highest satisfactory response. All questions are related to the functionality of the treatment (how easy it is to use and how the skin feels upon use)

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

Inclusion Criteria:

  • Have 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 body (trunk and/or limbs) that is amenable to topical treatment with a maximum of 15 g of trial medication per day
  • Have a PGA of disease severity of mild or moderate on the body (trunk and/or limbs)
  • Have an mPASI score of at least 3
  • Have a treatment area involving 2-30% of the body (trunk and/or limbs). For subjects with scalp psoriasis included in the treatment area, the total treatment area on body and scalp must not exceed 30%.

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 excessive or prolonged 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 Visit 1/Baseline 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
  • Presence of infections in the treatment area (bacteria, viruses, parasites or fungi) or skin manifestations of atrophic skin, atrophic striae, skin vein fragility, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers and wound in the treatment area
  • Known Human Immunodeficiency Virus (HIV) infection
  • Have 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
  • Initiation of, or expected changes to, concomitant medication that may affect psoriasis

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): NCT03802344

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Dermatovenerologie a korektivní dermatologie
Praha 1, Czechia, Těšnov 1163/5 110 00
University Medical Center Hamburg
Hamburg, Germany, 20246
Sponsors and Collaborators
MC2 Therapeutics
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Responsible Party: MC2 Therapeutics Identifier: NCT03802344    
Other Study ID Numbers: MC2-01-C7
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 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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Skin Diseases, Papulosquamous
Skin Diseases