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
Overview
- Phase
- Phase 3
- Intervention
- MC2-01 cream
- Conditions
- Psoriasis Vulgaris
- Sponsor
- MC2 Therapeutics
- Enrollment
- 498
- Locations
- 2
- Primary Endpoint
- Percentage Change in mPASI (Modified Psoriasis Area and Severity Index) Score
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
MC2-01 Cream
MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks
Intervention: MC2-01 cream
Cal/BDP combination
Calcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks
Intervention: Cal/BDP combination
Vehicle
One application daily for 8 weeks
Intervention: Vehicle
Outcomes
Primary Outcomes
Percentage Change in mPASI (Modified Psoriasis Area and Severity Index) Score
Time Frame: 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 Outcomes
- The Psoriasis Treatment Convenience Scale (PTCS)(8 Weeks)