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

Sponsor
MC2 Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT03802344
Collaborator
(none)
498
2
3
9.7
249
25.8

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

Study Type:
Interventional
Actual Enrollment :
498 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 12, 2018
Actual Primary Completion Date :
Oct 2, 2019
Actual Study Completion Date :
Oct 2, 2019

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

  1. 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

  1. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

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.
Responsible Party:
MC2 Therapeutics
ClinicalTrials.gov Identifier:
NCT03802344
Other Study ID Numbers:
  • MC2-01-C7
First Posted:
Jan 14, 2019
Last Update Posted:
Dec 16, 2020
Last Verified:
Nov 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

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

1. Primary Outcome
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)
2. Secondary Outcome
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

[Not Specified]

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
Email isa@mc2therapeutics.com
Responsible Party:
MC2 Therapeutics
ClinicalTrials.gov Identifier:
NCT03802344
Other Study ID Numbers:
  • MC2-01-C7
First Posted:
Jan 14, 2019
Last Update Posted:
Dec 16, 2020
Last Verified:
Nov 1, 2020