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A Clinical Trial Evaluating Efficacy and Safety of MC2-01 Cream

NCT ID: NCT03308799

Last Updated: 2024-12-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

794 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-03

Study Completion Date

2018-06-08

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Psoriasis Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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MC2-01 Cream

MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks

Group Type EXPERIMENTAL

MC2-01 cream

Intervention Type DRUG

MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream

Cal/BDP combination

Calcipotriene/betamethasone (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%). One application daily for 8 weeks.

Group Type ACTIVE_COMPARATOR

Cal/BDP combination

Intervention Type DRUG

calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%

Cream vehicle

One application daily for 8 weeks.

Group Type PLACEBO_COMPARATOR

Cream vehicle

Intervention Type DRUG

Vehicle Cream

Interventions

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MC2-01 cream

MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream

Intervention Type DRUG

Cal/BDP combination

calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%

Intervention Type DRUG

Cream vehicle

Vehicle Cream

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MC2 Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Linda S. Gold, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health System

Locations

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Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Minnesota Clinical Study Center

Fridley, Minnesota, United States

Site Status

Richard Herdener, MD

Spokane, Washington, United States

Site Status

Countries

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United States

References

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Pinter A, Galvan J, Freischlager F. Best Responders and Super-Responders to Calcipotriol and Betamethasone Dipropionate PAD-Cream: A Post Hoc Pooled Analysis of Two Phase 3 Trials. Dermatol Ther (Heidelb). 2025 Jun;15(6):1441-1453. doi: 10.1007/s13555-025-01418-x. Epub 2025 Apr 24.

Reference Type DERIVED
PMID: 40274711 (View on PubMed)

Stein Gold L, Pinter A, Armstrong A, Augustin M, Arenberger P, Bhatia N, Praestegaard M, Iversen L, Reich A. 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. Dermatol Ther (Heidelb). 2023 Sep;13(9):2031-2044. doi: 10.1007/s13555-023-00979-z. Epub 2023 Jul 25.

Reference Type DERIVED
PMID: 37490268 (View on PubMed)

Feldman SR, Praestegaard M, Andreasen AH, Selmer J, Holm-Larsen T. Validation of the Self-Reported Psoriasis Treatment Convenience Scale (PTCS). Dermatol Ther (Heidelb). 2021 Dec;11(6):2077-2088. doi: 10.1007/s13555-021-00626-5. Epub 2021 Oct 14.

Reference Type DERIVED
PMID: 34648147 (View on PubMed)

Stein Gold L, Green LJ, Dhawan S, Vestbjerg B, Praestegaard M, Selmer J. A Phase 3, Randomized Trial Demonstrating the Improved Efficacy and Patient Acceptability of Fixed Dose Calcipotriene and Betamethasone Dipropionate Cream. J Drugs Dermatol. 2021 Apr 1;20(4):420-425. doi: 10.36849/JDD.2021.5653.

Reference Type DERIVED
PMID: 33852251 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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MC2-01-C2

Identifier Type: -

Identifier Source: org_study_id