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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MC2-01 Cream | Experimental | MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks |
|
| Cal/BDP combination | Active Comparator | Calcipotriene/betamethasone (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%). One application daily for 8 weeks. |
|
| Cream vehicle | Placebo Comparator | One application daily for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MC2-01 cream | Drug | MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda S. Gold, MD | Henry Ford Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States | ||
| Minnesota Clinical Study Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40274711 | Derived | 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. | |
| 37490268 | Derived | 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. |
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Prior to randomization, the subject entered a washout period (if required) where anti-psoriatic treatment and other relevant medication/treatments were discontinued as defined by the exclusion criteria. The washout/screening period could last for up to 30 days, depending on which disallowed treatments the subject received.
First Subject First Visit: 03-Oct-2017. Last Subject Last Visit: 08-Jun-2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | MC2-01 Cream | MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks MC2-01 cream: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream |
| FG001 | CAL/BDP Combination | CAL/BDP (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%). One application daily for 8 weeks. CAL/BDP combination: calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064% |
| FG002 | Vehicle | One application daily for 8 weeks. Vehicle |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MC2-01 Cream | MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks MC2-01 cream: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream |
| BG001 | CAL/BDP Combination |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The analysis was based on the PP population. | Posted | Number | Count of participants | Baseline and 8 weeks |
|
AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MC2-01 Cream | MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks MC2-01 cream: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abscess | Skin and subcutaneous tissue disorders | MedDRA version 20.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Birgitte Vestbjerg | MC2 Therapeutics | +45 2077 2575 | bve@mc2therapeutics.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 27, 2018 | Jul 11, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 5, 2018 | Jul 11, 2019 | SAP_001.pdf |
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| Cal/BDP combination | Drug | calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064% |
|
| Cream vehicle | Drug | Vehicle Cream |
|
| Baseline and 8 weeks |
| 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 | 8 weeks |
| Fridley |
| Minnesota |
| 55432 |
| United States |
| Richard Herdener, MD | Spokane | Washington | 99202 | United States |
| 34648147 | Derived | 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. |
| 33852251 | Derived | 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. |
CAL/BDP (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%). One application daily for 8 weeks. CAL/BDP combination: calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064% |
| BG002 | Vehicle | One application daily for 8 weeks. Vehicle |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline PGA | Severity of psoriasis at Baseline | Count of Participants | Participants |
|
| Baseline mPASI | The extent and severity of the participant's psoriasis are assessed using a modified PASI scoring system at each 3 areas (arms, trunk and legs) using a scale from 0 - 6. 0 = no psoriasis involvement and 6 = 90-100% involvement.The severity is assessed at each for each of the sign redness, thickness and scaliness using a scale from 0 - 4. 0 represents none and 4 represents very severe. | Mean | Standard Deviation | Calculated score |
|
| Baseline BSA | Percentage involvement of psoriasis on the Body Surface Area at Baseline | Mean | Standard Deviation | Percentage |
|
| Fitzpatrick Skin Type | Fitzpatrick Skin Type was recorded at baseline using the following classification: I = Pale white skin, blue/hazel eyes, blond/red hair; II = Fair skin, blue eyes; III = Darker white skin; IV = Light brown skin; V = Brown skin; VI = Dark brown or black skin | Count of Participants | Participants |
|
| OG001 | CAL/BDP Combination | CAL/BDP (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%). One application daily for 8 weeks. CAL/BDP combination: calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064% |
| OG002 | Vehicle | One application daily for 8 weeks. Vehicle |
|
|
| Secondary | 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 | The analysis was based on the PP population. | Posted | Mean | Standard Deviation | Percentage of change | Baseline and 8 weeks |
|
|
|
| Secondary | 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 | The analysis population is defined as those patients from the PP population that have used study medication within 7 days prior to the day of assessment. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| 1 |
| 342 |
| 9 |
| 342 |
| 0 |
| 342 |
| EG001 | CAL/BDP Combination | CAL/BDP (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%). One application daily for 8 weeks. CAL/BDP combination: calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064% | 0 | 337 | 11 | 337 | 0 | 337 |
| EG002 | Vehicle | One application daily for 8 weeks. Vehicle | 1 | 115 | 5 | 115 | 0 | 115 |
| Angina Pectoris | Cardiac disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Renal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 20.1 | Non-systematic Assessment |
|
| Cervical Vertebral Fracture | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Nosocomial infection | Infections and infestations | MedDRA version 20.1 | Non-systematic Assessment |
|
| Acute Kidney injury | Renal and urinary disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA version 20.1 | Non-systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Pyrexia | Infections and infestations | MedDRA version 20.1 | Non-systematic Assessment |
|
| Application site cellulitis | Skin and subcutaneous tissue disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Diverculitis | Gastrointestinal disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Cervix Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 20.1 | Non-systematic Assessment |
|
| Cholecystitis | Gastrointestinal disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Ischaemic stroke | Cardiac disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Death | Cardiac disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less or equal to 60 days from the time submitted to the sponsor for review. At the end of the Review Period, the sponsor may reasonably require that publication be delayed to permit the filing of patent application. Publication shall not be delayed more than 90 days after receipt of the proposed publication.