Phase 3
Completed N=794
A Clinical Trial Evaluating Efficacy and Safety of MC2-01 Cream
Source: ClinicalTrials.gov NCT03308799 ↗Enrolled (actual)
794
Serious AEs
3.2%
Results posted
Oct 2019
Primary outcomePrimary: Number of Participants With a Decrease in the Physicians Global Assessment (PGA) Score of Minimum 2 Points on a Scale From 0-4 From Baseline to Week 8 — 121; 67; 4 Count of participants
◆ Published Evidence
Emerging
12citations · ~2 / year
A Phase 3, Randomized Trial Demonstrating the Improved Efficacy and Patient Acceptability of Fixed Dose Calcipotriene and Betamethasone Dipropionate Cream.
Summary
This trial is a randomized, investigator-blind, multicentre, vehicle- and comparator-controlled, parallel-group trial with the purpose of evaluating efficacy, safety and convenience of the MC2-01 cream.
Linked Publications (4)
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A Phase 3, Randomized Trial Demonstrating the Improved Efficacy and Patient Acceptability of Fixed Dose Calcipotriene and Betamethasone Dipropionate Cream.
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Validation of the Self-Reported Psoriasis Treatment Convenience Scale (PTCS).
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Calcipotriene and Betamethasone Dipropionate PAD-Cream Demonstrates Greater Treatment Efficacy in Patients with Moderate-to-Severe Psoriasis Compared to Topical Suspension/Gel: A Subgroup Analysis of Two Phase 3 Studies.
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Best Responders and Super-Responders to Calcipotriol and Betamethasone Dipropionate PAD-Cream: A Post Hoc Pooled Analysis of Two Phase 3 Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Decrease in the Physicians Global Assessment (PGA) Score of Minimum 2 Points on a Scale From 0-4 From Baseline to Week 8 |
121; 67; 4 | — |
| SECONDARY Percentage Change in mPASI Score |
64.8; 52.3; 25.7 | — |
| SECONDARY Psoriasis Treatment Convenience Scale |
41.6; 37.8; 37.2 | — |
Eligibility Criteria
Inclusion Criteria
- 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 trunk and/or limbs that is amenable to topical treatment with a maximum of 100 g of trial medication per week
- Have a PGA of disease severity of mild or moderate on the body (trunk and/or limbs)
- An mPASI score of at least 2
- Have a treatment area involving 2- 30% of the body surface area (BSA)
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 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 the baseline visit 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
- Clinical signs of skin infection with bacteria, viruses, or fungi
- Known Human Immunodeficiency Virus (HIV) infection
- 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
Data sourced from ClinicalTrials.gov (NCT03308799) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.