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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

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ClinicalTrials.gov Identifier: NCT03802344
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Drug Delivery Solutions Ltd. (part of MC2 Therapeutics)

Tracking Information
First Submitted Date  ICMJE January 10, 2019
First Posted Date  ICMJE January 14, 2019
Last Update Posted Date January 16, 2019
Actual Study Start Date  ICMJE December 12, 2018
Estimated Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
mPASI [ Time Frame: 8 Weeks ]
Percentage change from baseline in mPASI (modified Psoriasis Area and Severity Index) on trunk and/or limbs
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03802344 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2019)
  • 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, 4 = moderate or 5 = 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
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
  • PGA [ Time Frame: 8 Weeks ]
    PGA (Physicians Global Assessment) success, defined as a 2-point decrease on disease severity on the trunk and/or limbs as measured on a 5-point scale
  • PTCS [ Time Frame: 8 Weeks ]
    Subject assessment of treatment convenience as measured using the PTCS (Patient Treatment convenience Scale)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis Vulgaris
Intervention  ICMJE
  • Drug: MC2-01 cream
    MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream
  • Drug: Cal/BDP combination
    Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%
  • Drug: Vehicle
    Vehicle cream
Study Arms  ICMJE
  • Experimental: MC2-01 Cream
    MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks
    Intervention: Drug: MC2-01 cream
  • Active Comparator: Cal/BDP combination
    Calcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks
    Intervention: Drug: Cal/BDP combination
  • Placebo Comparator: Vehicle
    One application daily for 8 weeks
    Intervention: Drug: Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 10, 2019)
476
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 15, 2019
Estimated Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Birgitte Vestbjerg +4520772575 bve@mc2therapeutics.com
Listed Location Countries  ICMJE Czechia,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03802344
Other Study ID Numbers  ICMJE MC2-01-C7
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Drug Delivery Solutions Ltd. (part of MC2 Therapeutics)
Study Sponsor  ICMJE Drug Delivery Solutions Ltd. (part of MC2 Therapeutics)
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Drug Delivery Solutions Ltd. (part of MC2 Therapeutics)
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP