Last updated: November 26, 2020
Sponsor: MC2 Therapeutics
Overall Status: Completed
Phase
3
Condition
Psoriasis And Psoriatic Disorders
Rash
Rosacea
Treatment
N/AClinical Study ID
NCT03802344
MC2-01-C7
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Dermatovenerologie a korektivní dermatologie
Praha 1, Těšnov 1163/5 110 00
CzechiaSite Not Available
University Medical Center Hamburg
Hamburg, 20246
GermanySite Not Available
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