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

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.

• MC2-01 cream (Drug): MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream
• Cal/BDP combination (Drug): Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%
• Vehicle (Drug): Vehicle cream

Primary outcomes

• 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 outcomes

• 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 \[high satisfaction\].

Sex: All, ages: 18 Years to any

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

Participant flow

Outcome results

• Percentage Change in mPASI (Modified Psoriasis Area and Severity Index) Score (Primary), Mean, Percentage change from Baseline: MC2-01 Cream -67.5 +/- 20.8; Cal/BDP Combination -63.5 +/- 22.2; Vehicle -11.7 +/- 21.9
• The Psoriasis Treatment Convenience Scale (PTCS) (Secondary), Mean, score on a scale: MC2-01 Cream 38.6 +/- 6.2; Cal/BDP Combination 36.1 +/- 7.0; Vehicle 36.2 +/- 7.6

Adverse events

Time frame: AEs were collected/assessed from the time of the signature of the informed consent form by the subject and until the end of the trial, i.e. until the Follow-up visit at Week 10. AEs that were considered related to the trial product would be followed until they were resolved, or until the medical condition of the subject was stable.

Serious adverse events by term

Other adverse events by term

• Results publication: 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
• Results publication: 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
• Results publication: 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. PMID 36050567

• Study Protocol (PDF, 2018-10-16)
• Statistical Analysis Plan (PDF, 2019-10-07)