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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)

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)
Estimated Enrollment : 476 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
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 15, 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, 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

  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)



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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:

  • 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 ClinicalTrials.gov identifier (NCT number): NCT03802344


Contacts
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Contact: Birgitte Vestbjerg +4520772575 bve@mc2therapeutics.com

Locations
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Czechia
Dermatovenerologie a korektivní dermatologie Recruiting
Praha 1, Czechia, Těšnov 1163/5 110 00
Contact: Blanka Havlíčková, MD         
Germany
University Medical Center Hamburg Not yet recruiting
Hamburg, Germany, 20246
Contact: Matthias Augustin, Prof., MD         
Contact: L.         
Sponsors and Collaborators
Drug Delivery Solutions Ltd. (part of MC2 Therapeutics)

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Responsible Party: Drug Delivery Solutions Ltd. (part of MC2 Therapeutics)
ClinicalTrials.gov Identifier: NCT03802344     History of Changes
Other Study ID Numbers: MC2-01-C7
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 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
Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Calcipotriene
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents