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

Last updated: November 26, 2020
Sponsor: MC2 Therapeutics
Overall Status: Completed

Phase

3

Condition

Psoriasis And Psoriatic Disorders

Rash

Rosacea

Treatment

N/A

Clinical Study ID

NCT03802344
MC2-01-C7
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have provided written informed consent
  • Generally healthy males or non-pregnant females, of any race or ethnicity, who are atleast 18 years of age at the time of screening
  • Have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6months duration that involves the body (trunk and/or limbs) that is amenable totopical 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 subjectswith scalp psoriasis included in the treatment area, the total treatment area on bodyand scalp must not exceed 30%.

Exclusion

Exclusion Criteria:

  • Current diagnosis of unstable forms of psoriasis
  • Other inflammatory skin disease in the treatment area that may confound the evaluationof the psoriasis vulgaris
  • Presence of pigmentation, extensive scarring, pigmented lesions or sunburn in thetreatment 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 renalinsufficiency, or severe hepatic disorders
  • Systemic treatment with biological therapies
  • Use of systemic treatments that suppress the immune system and other systemicchemotherapeutic antineoplastic therapy within 4 weeks prior to Visit 1/Baseline andduring 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 apossible 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 treatmentarea
  • Known Human Immunodeficiency Virus (HIV) infection
  • Have any chronic or acute medical condition that may pose a risk to the safety of thesubject, or may interfere with the assessment of safety or efficacy in this trial
  • Initiation of, or expected changes to, concomitant medication that may affectpsoriasis

Study Design

Total Participants: 498
Study Start date:
December 12, 2018
Estimated Completion Date:
October 02, 2019

Study 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.

Connect with a study center

  • Dermatovenerologie a korektivní dermatologie

    Praha 1, Těšnov 1163/5 110 00
    Czechia

    Site Not Available

  • University Medical Center Hamburg

    Hamburg, 20246
    Germany

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.