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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

NCT ID: NCT03802344

Last Updated: 2020-12-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

498 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-12

Study Completion Date

2019-10-02

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 the 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

TRIPLE

Participants Investigators Outcome Assessors

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%) cream. 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%

Vehicle

One application daily for 8 weeks

Group Type PLACEBO_COMPARATOR

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

Vehicle

Vehicle cream

Intervention Type DRUG

Eligibility Criteria

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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
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

Locations

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Dermatovenerologie a korektivní dermatologie

Prague, , Czechia

Site Status

University Medical Center Hamburg

Hamburg, , Germany

Site Status

Countries

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Czechia Germany

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)

Praestegaard M, Steele F, Crutchley N. Polyaphron Dispersion Technology, A Novel Topical Formulation and Delivery System Combining Drug Penetration, Local Tolerability and Convenience of Application. Dermatol Ther (Heidelb). 2022 Oct;12(10):2217-2231. doi: 10.1007/s13555-022-00794-y. Epub 2022 Sep 1.

Reference Type DERIVED
PMID: 36050567 (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-C7

Identifier Type: -

Identifier Source: org_study_id