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

Phase 3

Completed

Conditions: Psoriasis Vulgaris

Interventions: Drug: MC2-01 cream
Drug: Vehicle
Drug: Cal/BDP combination

Registration Number: NCT03802344

Lead Sponsor: MC2 Therapeutics

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 498

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MC2-01 Cream	MC2-01 cream	MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks
Vehicle	Vehicle	One application daily for 8 weeks
Cal/BDP combination	Cal/BDP combination	Calcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks

Primary Outcome Measures

Name	Time	Method
Percentage Change in mPASI (Modified Psoriasis Area and Severity Index) Score	8 Weeks	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)

Secondary Outcome Measures

Name	Time	Method
The Psoriasis Treatment Convenience Scale (PTCS)	8 Weeks	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 \[high satisfaction\].

Trial Locations

Locations (2): Dermatovenerologie a korektivní dermatologie
🇨🇿
Praha 1, Czechia
University Medical Center Hamburg
🇩🇪
Hamburg, Germany
Dermatovenerologie a korektivní dermatologie
🇨🇿Praha 1, Czechia