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 the 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%
DRUGVehicle
Vehicle cream
Sponsors
MC2 Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 \[high satisfaction\]. |
Countries
Czechia, Germany
Participant flow
Recruitment details
First Subject First Visit: 12-Dec-2018. Last Subject Last Visit: 02-Oct-2019.
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. 498 subjects signed the Informed consent form, 490 subjects were randomized and randomly assigned into 3 treatment groups (MC2-01 cream, active comparator, MC2-01 vehicle).
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 | 213 |
| Cal/BDP Combination Calcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks
Cal/BDP combination: Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064% | 209 |
| Vehicle One application daily for 8 weeks
Vehicle: Vehicle | 68 |
| Total | 490 |
Baseline characteristics
| Characteristic | MC2-01 Cream | Total | Vehicle | Cal/BDP Combination |
|---|---|---|---|---|
| Age, Continuous | 48.6 years STANDARD_DEVIATION 13.7 | 50.2 years STANDARD_DEVIATION 14.02 | 50.8 years STANDARD_DEVIATION 13.1 | 51.5 years STANDARD_DEVIATION 14.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 213 Participants | 490 Participants | 68 Participants | 209 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Type I | 6 Participants | 8 Participants | 0 Participants | 2 Participants |
| Fitzpatrick Skin Type II | 104 Participants | 236 Participants | 29 Participants | 103 Participants |
| Fitzpatrick Skin Type III | 77 Participants | 178 Participants | 25 Participants | 76 Participants |
| Fitzpatrick Skin Type IV | 20 Participants | 48 Participants | 9 Participants | 19 Participants |
| Fitzpatrick Skin Type V | 6 Participants | 18 Participants | 5 Participants | 7 Participants |
| Fitzpatrick Skin Type VI | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Asian | 1 Participants | 3 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Black or African American | 0 Participants | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Gipsy | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race North African | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race White | 211 Participants | 481 Participants | 65 Participants | 205 Participants |
| Region of Enrollment Czechia | 64 participants | 147 participants | 20 participants | 63 participants |
| Region of Enrollment Germany | 94 participants | 214 participants | 30 participants | 90 participants |
| Region of Enrollment Poland | 55 participants | 129 participants | 18 participants | 56 participants |
| Sex: Female, Male Female | 77 Participants | 195 Participants | 22 Participants | 96 Participants |
| Sex: Female, Male Male | 136 Participants | 295 Participants | 46 Participants | 113 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 213 | 0 / 209 | 0 / 68 |
| other Total, other adverse events | 10 / 213 | 11 / 209 | 1 / 68 |
| serious Total, serious adverse events | 1 / 213 | 3 / 209 | 1 / 68 |
Outcome results
Primary
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)
Time frame: 8 Weeks
Population: The analysis was based on the FAS population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MC2-01 Cream | Percentage Change in mPASI (Modified Psoriasis Area and Severity Index) Score | -67.5 Percentage change from Baseline | Standard Error 20.8 |
| Cal/BDP Combination | Percentage Change in mPASI (Modified Psoriasis Area and Severity Index) Score | -63.5 Percentage change from Baseline | Standard Error 22.2 |
| Vehicle | Percentage Change in mPASI (Modified Psoriasis Area and Severity Index) Score | -11.7 Percentage change from Baseline | Standard Error 21.9 |
Secondary
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 \[high satisfaction\].
Time frame: 8 Weeks
Population: The analysis was based on the FAS population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MC2-01 Cream | The Psoriasis Treatment Convenience Scale (PTCS) | 38.6 score on a scale | Standard Deviation 6.2 |
| Cal/BDP Combination | The Psoriasis Treatment Convenience Scale (PTCS) | 36.1 score on a scale | Standard Deviation 7 |
| Vehicle | The Psoriasis Treatment Convenience Scale (PTCS) | 36.2 score on a scale | Standard Deviation 7.6 |