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

NCT03308799 | Completed Phase 3 Results FDA Drug

• 1 other identifier: MC2-01-C2
• Study Type: interventional
• Target: 794
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• 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

  Psoriasis treatment success rate is measured at week 8 by the use of a Physician Global Assessment (PGA) score. Success is defined as a decrease from Baseline of minimum 2 point on a scale from 0 - 4, where: 0 = Clear; 1 = Almost clear; 2 = Mild Plaque thickening; 3 = Moderate Plaque thickening, 4 = Severe Plaque thickening. The number of participants referred in the data sets are the number of participants, who achieved a successful treatment success.

  Baseline and 8 weeks

Secondary Outcomes (2)

• Percentage Change in mPASI Score

  Baseline and 8 weeks

• Psoriasis Treatment Convenience Scale

  8 weeks

Study Arms (3)

MC2-01 Cream

EXPERIMENTAL

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

Drug: MC2-01 cream

Cal/BDP combination

ACTIVE COMPARATOR

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

Drug: Cal/BDP combination

Cream vehicle

PLACEBO COMPARATOR

One application daily for 8 weeks.

Drug: Cream vehicle

Interventions

MC2-01 cream DRUG

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

MC2-01 Cream

Cal/BDP combination DRUG

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

Cal/BDP combination

Cream vehicle DRUG

Vehicle Cream

Cream vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• MC2 Therapeutics: lead

Study Sites (3)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Richard Herdener, MD

Spokane, Washington, 99202, United States

Location

Related Publications (4)

• 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.

  PMID: 40274711 DERIVED

• 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.

  PMID: 37490268 DERIVED

• 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.

  PMID: 34648147 DERIVED

• 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.

  PMID: 33852251 DERIVED

Results Point of Contact

• Title: Birgitte Vestbjerg
• Organization: MC2 Therapeutics

bve@mc2therapeutics.com

+45 2077 2575

Study Officials

• Linda S. Gold, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: October 13, 2017
• Study Start: October 3, 2017
• Primary Completion: June 8, 2018
• Study Completion: June 8, 2018
• Last Updated: December 9, 2024
• Results First Posted: October 29, 2019

Record last verified: 2024-11

Locations

US (3)