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Psoriasis VulgarisPhase 3NCT03308799

A Clinical Trial Evaluating Efficacy and Safety of 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 3 sites in United States.

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 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
794 participants
Where
3 sitesUnited States
Study dates
3 Oct 2017to 8 Jun 2018
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

  • 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 trunk and/or limbs that is amenable to topical treatment with a maximum of 100 g of trial medication per week
  • Have a PGA of disease severity of mild or moderate on the body (trunk and/or limbs)
  • An mPASI score of at least 2
  • Have a treatment area involving 2- 30% of the body surface area (BSA)

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 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 13Show 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 the baseline visit 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
  • Clinical signs of skin infection with bacteria, viruses, or fungi
  • Known Human Immunodeficiency Virus (HIV) infection
  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Minnesota Clinical Study Center

    Fridley, Minnesota, 55432

  • Richard Herdener, MD

    Spokane, Washington, 99202

Other trials in United States

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 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, Cream 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%

  • Cream vehicleDrug

    Vehicle Cream

Study groups in NCT03308799
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%). One application daily for 8 weeks.
Receives: Drug: Cal/BDP combination
Cream vehiclePlacebo comparatorOne application daily for 8 weeks.
Receives: Drug: Cream vehicle

What is being measured

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

  1. Number of Participants With a Decrease in the Physicians Global Assessment (PGA) Score of Minimum 2 Points on a Scale From 0-4 From Baseline to Week 8

    Psoriasis treatment success rate is measured at week 8 by the use of a Physician Global Assessment (PGA) score. Success is defined as a decrease from Baseline of minimum 2 point on a scale from 0 - 4, where: 0 = Clear; 1 = Almost clear; 2 = Mild Plaque thickening; 3 = Moderate Plaque thickening, 4 = Severe Plaque thickening.

    The number of participants referred in the data sets are the number of participants, who achieved a successful treatment success.

    Measured: Baseline and 8 weeks

Secondary outcomes (2)

  1. Percentage Change in mPASI 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 each 3 areas (arms, trunk and legs) 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

    Measured: Baseline and 8 weeks

  2. Psoriasis Treatment Convenience Scale

    Subject assessment of treatment convenience using a Psoriasis Treatment Convenience Scale is defined as a sum of questions 1-5, where each question is scored on a scale from 1-10.

    How easy was the treatment to apply to the skin? "Very difficult" is 1 and "Very easy" is 10 How greasy was the treatment when applying it to the skin? "Very greasy" is 1 and "Not greasy" is 10 How moisturised did your skin feel after applying the treatment? "Not moisturized" is 1 and "Very moisturized" is 10 How greasy did your skin feel after applying the treatment? "Very greasy" is 1 and "Not greasy" is 10 How much did treating your skin disrupt your daily routine? "Very disturbing" is 1 and "Not disturbing" is 10

    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 posted13 Oct 2017
  2. Study start3 Oct 2017
  3. Primary completion8 Jun 2018
  4. Study completion8 Jun 2018

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
Single blind
Who is masked
Investigator
Enrolment
794 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03308799
Sponsor's protocol ID
MC2-01-C2
Status last verified
Nov 2024
First submitted
9 Oct 2017
Last updated
9 Dec 2024
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

  • Feldman SR, Praestegaard M, Andreasen AH, Selmer J, Holm-Larsen T. Validation of the Self-Reported Psoriasis Treatment Convenience Scale (PTCS). Dermatol Ther (Heidelb). 2021 Dec;11(6):2077-2088. doi: 10.1007/s13555-021-00626-5. Epub 2021 Oct 14.

    PubMed 34648147

  • Stein Gold L, Green LJ, Dhawan S, Vestbjerg B, Praestegaard M, Selmer J. A Phase 3, Randomized Trial Demonstrating the Improved Efficacy and Patient Acceptability of Fixed Dose Calcipotriene and Betamethasone Dipropionate Cream. J Drugs Dermatol. 2021 Apr 1;20(4):420-425. doi: 10.36849/JDD.2021.5653.

    PubMed 33852251

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 3 sites in United States.

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 13 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 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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 29 Oct 2019). 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?

Number of Participants With a Decrease in the Physicians Global Assessment (PGA) Score of Minimum 2 Points on a Scale From 0-4 From Baseline to Week 8 (time frame: Baseline and 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 NCT03308799, which also lists 4 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 9 Dec 2024.

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