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AzTrials

Psoriasis VulgarisPhase 3NCT03802344

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 Phase 3 study testing MC2-01 cream and Cal/BDP combination in people with Psoriasis Vulgaris, run by MC2 Therapeutics at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis Vulgaris
What is being tested?
MC2-01 cream and Cal/BDP combination
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
498 participants
Where
2 sitesin 2 countries
Study dates
12 Dec 2018to 2 Oct 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%.

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Czechia1 site

  • Dermatovenerologie a korektivní dermatologie

    Prague, Těšnov 1163/5 110 00

Other trials in Czechia

Germany1 site

  • University Medical Center Hamburg

    Hamburg, 20246

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Being tested
MC2-01 cream, Cal/BDP combination, Vehicle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MC2-01 creamDrug

    MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream

  • Cal/BDP combinationDrug

    Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%

  • VehicleDrug

    Vehicle cream

Study groups in NCT03802344
Study groupRoleWhat they receive
MC2-01 CreamExperimentalMC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks
Receives: Drug: MC2-01 cream
Cal/BDP combinationActive comparatorCalcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks
Receives: Drug: Cal/BDP combination
VehiclePlacebo comparatorOne application daily for 8 weeks
Receives: Drug: Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 8 Weeks

Secondary outcomes (1)

  1. 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].

    Measured: 8 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2019
  2. Study start12 Dec 2018
  3. Primary completion2 Oct 2019
  4. Study completion2 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
498 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03802344
Sponsor's protocol ID
MC2-01-C7
Status last verified
Nov 2020
First submitted
10 Jan 2019
Last updated
16 Dec 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 40274711

  • 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.

    PubMed 37490268

  • 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.

    PubMed 36050567

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MC2-01 cream and Cal/BDP combination in people with Psoriasis Vulgaris, run by MC2 Therapeutics at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Czechia, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change in mPASI (Modified Psoriasis Area and Severity Index) Score (time frame: 8 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03802344, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2020; AzTrials last refreshed its copy on 6 Nov 2026.

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