Psoriasis Vulgaris
Conditions
Brief 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.
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.
Interventions
DRUGMC2-01 cream
MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream
calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%
DRUGCream vehicle
Vehicle Cream
Sponsors
MC2 Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
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 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline and 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in mPASI Score | Baseline and 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 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 |
| Psoriasis Treatment Convenience Scale | 8 weeks | 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 |
Countries
United States
Participant flow
Recruitment details
First Subject First Visit: 03-Oct-2017. Last Subject Last Visit: 08-Jun-2018.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 342 |
| 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% | 337 |
| Vehicle One application daily for 8 weeks.
Vehicle | 115 |
| Total | 794 |
Baseline characteristics
| Characteristic | Total | Vehicle | MC2-01 Cream | CAL/BDP Combination |
|---|---|---|---|---|
| Age, Continuous | 52.0 Years STANDARD_DEVIATION 14.1 | 50.4 Years STANDARD_DEVIATION 14.3 | 52.0 Years STANDARD_DEVIATION 14.4 | 52.6 Years STANDARD_DEVIATION 13.7 |
| Baseline BSA | 7.8 Percentage STANDARD_DEVIATION 6.5 | 7.5 Percentage STANDARD_DEVIATION 6.1 | 7.3 Percentage STANDARD_DEVIATION 6 | 8.4 Percentage STANDARD_DEVIATION 7 |
| Baseline mPASI | 7.4 Calculated score STANDARD_DEVIATION 4 | 7.1 Calculated score STANDARD_DEVIATION 4.1 | 7.3 Calculated score STANDARD_DEVIATION 3.9 | 7.7 Calculated score STANDARD_DEVIATION 4.1 |
| Baseline PGA Mild psoriasis | 145 Participants | 20 Participants | 68 Participants | 57 Participants |
| Baseline PGA Moderate psoriasis | 649 Participants | 95 Participants | 274 Participants | 280 Participants |
| Fitzpatrick Skin Type I | 51 Participants | 9 Participants | 21 Participants | 21 Participants |
| Fitzpatrick Skin Type II | 204 Participants | 30 Participants | 86 Participants | 88 Participants |
| Fitzpatrick Skin Type III | 253 Participants | 37 Participants | 104 Participants | 112 Participants |
| Fitzpatrick Skin Type IV | 183 Participants | 23 Participants | 87 Participants | 73 Participants |
| Fitzpatrick Skin Type V | 67 Participants | 9 Participants | 30 Participants | 28 Participants |
| Fitzpatrick Skin Type VI | 36 Participants | 7 Participants | 14 Participants | 15 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 7 Participants | 1 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Asian | 21 Participants | 1 Participants | 10 Participants | 10 Participants |
| Race/Ethnicity, Customized Race Black or African American | 65 Participants | 11 Participants | 34 Participants | 20 Participants |
| Race/Ethnicity, Customized Race Mutiple | 5 Participants | 0 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 3 Participants | 0 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Other | 2 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race White | 691 Participants | 102 Participants | 290 Participants | 299 Participants |
| Region of Enrollment United States | 794 participants | 115 participants | 342 participants | 337 participants |
| Sex: Female, Male Female | 299 Participants | 44 Participants | 139 Participants | 116 Participants |
| Sex: Female, Male Male | 495 Participants | 71 Participants | 203 Participants | 221 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 342 | 0 / 337 | 1 / 115 |
| other Total, other adverse events | 0 / 342 | 0 / 337 | 0 / 115 |
| serious Total, serious adverse events | 9 / 342 | 11 / 337 | 5 / 115 |
Outcome results
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.
Time frame: Baseline and 8 weeks
Population: The analysis was based on the PP population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MC2-01 Cream | 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 | 121 Count of participants |
| CAL/BDP Combination | 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 | 67 Count of participants |
| Vehicle | 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 | 4 Count of participants |
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
Time frame: Baseline and 8 weeks
Population: The analysis was based on the PP population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MC2-01 Cream | Percentage Change in mPASI Score | 64.8 Percentage of change | Standard Deviation 28.7 |
| CAL/BDP Combination | Percentage Change in mPASI Score | 52.3 Percentage of change | Standard Deviation 33.3 |
| Vehicle | Percentage Change in mPASI Score | 25.7 Percentage of change | Standard Deviation 35.3 |
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
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MC2-01 Cream | Psoriasis Treatment Convenience Scale | 41.6 score on a scale | Standard Deviation 6.6 |
| CAL/BDP Combination | Psoriasis Treatment Convenience Scale | 37.8 score on a scale | Standard Deviation 7.6 |
| Vehicle | Psoriasis Treatment Convenience Scale | 37.2 score on a scale | Standard Deviation 7.1 |