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

A Randomised, Multicentre, Investigator-Blind, Parallel-Group Trial to Evaluate the Efficacy and Safety of MC2-01 Cream Compared to Vehicle and Active Comparator in Subjects With Mild-to-Moderate Psoriasis Vulgaris

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Drug: MC2-01 cream; Drug: Cal/BDP combination; Drug: Vehicle

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 498
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czechia
  • Praha 1, Czechia, Těšnov 1163/5 110 00
    • Dermatovenerologie a korektivní dermatologie
• Germany
  • Hamburg, Germany, 20246
    • University Medical Center Hamburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MC2-01 Cream; MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks	Drug: MC2-01 cream; MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream
ACTIVE_COMPARATOR: Cal/BDP combination; Calcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks	Drug: Cal/BDP combination; Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%
PLACEBO_COMPARATOR: Vehicle; One application daily for 8 weeks	Drug: Vehicle; Vehicle cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change in mPASI (Modified Psoriasis Area and Severity Index) Score	The extent and severity of the participant's psoriasis is assessed using a modified PASI scoring system (minus scalp, face, and flexures) at each 3 areas (arms, trunk and legs) using a scale from 0 - 6, where 0 = no psoriasis involvement and 6 = 90-100% involvement. The severity is assessed at the 3 areas for each of the sign redness, thickness and scaliness using a scale from 0 - 4, where 0 represents none and 4 represents very severe. The mPASI score is calculated from the individual scores by use of the following equation: Arms 0.2 (Redness + Thickness + Scaliness) E = X Trunk 0.3 (Redness + Thickness + Scaliness) E = Y Legs 0.4 (Redness + Thickness + Scaliness) E = Z The sum of X + Y + Z = m-PASI score resulting in a minimum score of 0 and a maximum score (worst possible) of 64.8. The percent change in mPASI score is defined as the Baseline minus the Week 8 divided by Baseline score multiplied by 100 (if a reduction is seen the value will be presented as a negative number)	8 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Psoriasis Treatment Convenience Scale (PTCS)	PTCS measures the impact and convenience of the treatment. The scale consists of 6 disease-specific questions, which individually will be rated on a 1-10 points scale, where a score of 1 represents the lowest satisfactory response with the treatment and 10 represents the highest satisfactory response. The questions are: Q1. How easy was the treatment to apply to the skin?; Q2. How greasy was the treatment when applying it to the skin?; Q3. How moisturized did your skin feel after apolying the treatment?; Q4. How greasy did your skin feel after applying the treatment?; Q5. How much did treating you skin disrupt your daily routine?; Q6. Overall, how satisfied were you with the medical treatment? The total PTCS score is calculated as the sum of the first 5 questions, ranging from 5 [low satisfaction] to 50 [high satisfaction].	8 Weeks

Collaborators and Investigators

• Sponsor: MC2 Therapeutics

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 12, 2018
• Primary Completion (ACTUAL): October 2, 2019
• Study Completion (ACTUAL): October 2, 2019

Study Registration Dates

• First Submitted: January 10, 2019
• First Submitted That Met QC Criteria: January 10, 2019
• First Posted (ACTUAL): January 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 16, 2020
• Last Update Submitted That Met QC Criteria: November 26, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: MC2-01-C7

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No