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
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: MC2-01 Cream MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks |
Drug: MC2-01 cream
MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream
|
Active Comparator: Cal/BDP combination Calcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks |
Drug: Cal/BDP combination
Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%
|
Placebo Comparator: Vehicle One application daily for 8 weeks |
Drug: Vehicle
Vehicle cream
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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].
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Dermatovenerologie a korektivní dermatologie | Praha 1 | Czechia | Těšnov 1163/5 110 00 | |
2 | University Medical Center Hamburg | Hamburg | Germany | 20246 |
Sponsors and Collaborators
- MC2 Therapeutics
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- MC2-01-C7
Study Results
Participant Flow
Recruitment Details | First Subject First Visit: 12-Dec-2018. Last Subject Last Visit: 02-Oct-2019. |
---|---|
Pre-assignment Detail | 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). |
Arm/Group Title | MC2-01 Cream | Cal/BDP Combination | Vehicle |
---|---|---|---|
Arm/Group Description | 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 | 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% | One application daily for 8 weeks Vehicle: Vehicle |
Period Title: Overall Study | |||
STARTED | 213 | 209 | 68 |
COMPLETED | 205 | 203 | 55 |
NOT COMPLETED | 8 | 6 | 13 |
Baseline Characteristics
Arm/Group Title | MC2-01 Cream | Cal/BDP Combination | Vehicle | Total |
---|---|---|---|---|
Arm/Group Description | 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 | 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% | One application daily for 8 weeks Vehicle: Vehicle | Total of all reporting groups |
Overall Participants | 213 | 209 | 68 | 490 |
Age (years) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [years] |
48.6
(13.7)
|
51.5
(14.8)
|
50.8
(13.1)
|
50.2
(14.02)
|
Sex: Female, Male (Count of Participants) | ||||
Female |
77
36.2%
|
96
45.9%
|
22
32.4%
|
195
39.8%
|
Male |
136
63.8%
|
113
54.1%
|
46
67.6%
|
295
60.2%
|
Ethnicity (NIH/OMB) (Count of Participants) | ||||
Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Not Hispanic or Latino |
213
100%
|
209
100%
|
68
100%
|
490
100%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Race/Ethnicity, Customized (Count of Participants) | ||||
White |
211
99.1%
|
205
98.1%
|
65
95.6%
|
481
98.2%
|
Black or African American |
0
0%
|
0
0%
|
2
2.9%
|
2
0.4%
|
Asian |
1
0.5%
|
2
1%
|
0
0%
|
3
0.6%
|
Gipsy |
1
0.5%
|
1
0.5%
|
0
0%
|
2
0.4%
|
North African |
0
0%
|
1
0.5%
|
1
1.5%
|
2
0.4%
|
Region of Enrollment (participants) [Number] | ||||
Czechia |
64
30%
|
63
30.1%
|
20
29.4%
|
147
30%
|
Germany |
94
44.1%
|
90
43.1%
|
30
44.1%
|
214
43.7%
|
Poland |
55
25.8%
|
56
26.8%
|
18
26.5%
|
129
26.3%
|
Fitzpatrick Skin Type (Count of Participants) | ||||
I |
6
2.8%
|
2
1%
|
0
0%
|
8
1.6%
|
II |
104
48.8%
|
103
49.3%
|
29
42.6%
|
236
48.2%
|
III |
77
36.2%
|
76
36.4%
|
25
36.8%
|
178
36.3%
|
IV |
20
9.4%
|
19
9.1%
|
9
13.2%
|
48
9.8%
|
V |
6
2.8%
|
7
3.3%
|
5
7.4%
|
18
3.7%
|
VI |
0
0%
|
2
1%
|
0
0%
|
2
0.4%
|
Outcome Measures
Title | Percentage Change in mPASI (Modified Psoriasis Area and Severity Index) Score |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
The analysis was based on the FAS population. |
Arm/Group Title | MC2-01 Cream | Cal/BDP Combination | Vehicle |
---|---|---|---|
Arm/Group Description | 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 | 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% | One application daily for 8 weeks Vehicle: Vehicle |
Measure Participants | 213 | 209 | 68 |
Mean (Standard Error) [Percentage change from Baseline] |
-67.5
(20.8)
|
-63.5
(22.2)
|
-11.7
(21.9)
|
Title | The Psoriasis Treatment Convenience Scale (PTCS) |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
The analysis was based on the FAS population. |
Arm/Group Title | MC2-01 Cream | Cal/BDP Combination | Vehicle |
---|---|---|---|
Arm/Group Description | 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 | 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% | One application daily for 8 weeks Vehicle: Vehicle cream |
Measure Participants | 213 | 209 | 68 |
Mean (Standard Deviation) [score on a scale] |
38.6
(6.2)
|
36.1
(7.0)
|
36.2
(7.6)
|
Adverse Events
Time Frame | AEs were collected/assessed from the time of the signature of the informed consent form by the subject and until the end of the trial, i.e. until the Follow-up visit at Week 10. AEs that were considered related to the trial product would be followed until they were resolved, or until the medical condition of the subject was stable. | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||
Arm/Group Title | MC2-01 Cream | Cal/BDP Combination | Vehicle | |||
Arm/Group Description | 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 | 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% | One application daily for 8 weeks Vehicle: Vehicle | |||
All Cause Mortality |
||||||
MC2-01 Cream | Cal/BDP Combination | Vehicle | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/213 (0%) | 0/209 (0%) | 0/68 (0%) | |||
Serious Adverse Events |
||||||
MC2-01 Cream | Cal/BDP Combination | Vehicle | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/213 (0.5%) | 3/209 (1.4%) | 1/68 (1.5%) | |||
Gastrointestinal disorders | ||||||
Cholesystitis acute | 0/213 (0%) | 0 | 0/209 (0%) | 0 | 1/68 (1.5%) | 1 |
Infections and infestations | ||||||
Herpes zoster meningitis | 0/213 (0%) | 0 | 1/209 (0.5%) | 1 | 0/68 (0%) | 0 |
Pulmonary tuberculosis | 0/213 (0%) | 0 | 1/209 (0.5%) | 1 | 0/68 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||||
Humerus fracture | 0/213 (0%) | 0 | 1/209 (0.5%) | 1 | 0/68 (0%) | 0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
Testicular seminoma | 1/213 (0.5%) | 1 | 0/209 (0%) | 0 | 0/68 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
MC2-01 Cream | Cal/BDP Combination | Vehicle | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 10/213 (4.7%) | 11/209 (5.3%) | 1/68 (1.5%) | |||
Infections and infestations | ||||||
Nasopharyngitis | 10/213 (4.7%) | 10 | 11/209 (5.3%) | 11 | 1/68 (1.5%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Irene Sandholdt |
---|---|
Organization | MC2 Therapeutics |
Phone | +45 2015 7033 |
isa@mc2therapeutics.com |
- MC2-01-C7