Trial Outcomes & Findings for Evaluation of the Vasoconstriction Properties of MC2-01 Cream (NCT NCT03758365)
NCT ID: NCT03758365
Last Updated: 2020-01-09
Results Overview
Blanching of the skin will be assessed individually by two trained observers blinded to treatment. The observers will score the blanching of the skin from 0-4 (0 = No change in color skin; 1 = Slight (barely visible) blanching; 3 = Obvious blanching; 4 = Blanching judged to be maximal). The results is presented as Mean ± SD.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
Day 2
Results posted on
2020-01-09
Participant Flow
First Subject First Visit: 07-Nov-2018. Last Subject Last Visit: 23-Nov-2018
The study consist of a screening period up to 15 day prior to randomization, a test period and a follow-up period. The study design is a within subject evaluation of the vasoconstriction properties of MC2-01 cream compared with vehicle cream and 5 other corticosteroids. All subjects received therefore a single treatment with all 7 products.
Participant milestones
| Measure |
MC2-01 Cream + Comparators
Single application of 7 different treatments, where different sections on the arm was randomized to the following interventions:
1. \- MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream
2. \- Clobetasol Propionate 0.05% Lotion
3. \- Betamethasone Dipropionate 0.05% Cream
4. \- Triamcinolone Acetonide 0.1% Cream
5. \- Hydrocortisone Butyrate 0.1% Cream
6. \- Desonide 0.05% Cream
7. \- Vehicle Cream
to perform visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
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|---|---|
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Overall Study
STARTED
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36
|
|
Overall Study
MC2-01 Cream
|
36
|
|
Overall Study
Clobetasol Propionate 0.05% Lotion
|
36
|
|
Overall Study
Betamethasone Dipropionate 0.05% Cream
|
36
|
|
Overall Study
Triamcinolone Acetonide 0,1% Cream
|
36
|
|
Overall Study
Hydrocortisone Butyrate 0.1% Cream
|
36
|
|
Overall Study
Desonide 0.05% Cream
|
36
|
|
Overall Study
Vehicle Cream
|
36
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
36 patients participated and they received all types of treatment. Therefore analyses of the 7 treatments arms were done for all 36 patients.
Baseline characteristics by cohort
| Measure |
MC2-01 Cream + Comparators
n=36 Participants
Single application of 7 different treatments, where different sections on the arm was randomized to the following interventions:
1. \- MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream
2. \- Clobetasol Propionate 0.05% Lotion
3. \- Betamethasone Dipropionate 0.05% Cream
4. \- Triamcinolone Acetonide 0.1% Cream
5. \- Hydrocortisone Butyrate 0.1% Cream
6. \- Desonide 0.05% Cream
7. \- Vehicle Cream
to perform visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
|
|---|---|
|
Age, Continuous
|
34.36 years
STANDARD_DEVIATION 6.57 • n=36 Participants • 36 patients participated and they received all types of treatment. Therefore analyses of the 7 treatments arms were done for all 36 patients.
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|
Sex: Female, Male
Female
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28 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=36 Participants
|
|
Region of Enrollment
France
|
36 participants
n=36 Participants
|
|
Fitzpatrick Skin Type
I
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0 Participants
n=36 Participants
|
|
Fitzpatrick Skin Type
II
|
9 Participants
n=36 Participants
|
|
Fitzpatrick Skin Type
III
|
24 Participants
n=36 Participants
|
|
Fitzpatrick Skin Type
IV
|
3 Participants
n=36 Participants
|
|
Fitzpatrick Skin Type
V
|
0 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Day 2Population: As the study design is a within subject evaluation of the vasoconstriction properties of MC2-01 cream compared with vehicle cream and 5 other corticosteroids, all 36 enrolled subjects received a single treatment with all 7 products.
Blanching of the skin will be assessed individually by two trained observers blinded to treatment. The observers will score the blanching of the skin from 0-4 (0 = No change in color skin; 1 = Slight (barely visible) blanching; 3 = Obvious blanching; 4 = Blanching judged to be maximal). The results is presented as Mean ± SD.
Outcome measures
| Measure |
MC2-01 Cream + Comparators
n=36 Participants
Single application of MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream
MC2-01 Cream: Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
|
|---|---|
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Comparison of the Vasoconstriction Potential (Skin Blanching Effect) of the MC2-01 Cream With Active Comparators and Vehicle
MC2-01 Cream
|
1.66 score on a scale
Standard Deviation 0.57
|
|
Comparison of the Vasoconstriction Potential (Skin Blanching Effect) of the MC2-01 Cream With Active Comparators and Vehicle
Clobetasol Propionate 0.05% Lotion
|
3.05 score on a scale
Standard Deviation 0.65
|
|
Comparison of the Vasoconstriction Potential (Skin Blanching Effect) of the MC2-01 Cream With Active Comparators and Vehicle
Betamethasone Dipropionate 0.05% Cream
|
2.45 score on a scale
Standard Deviation 0.61
|
|
Comparison of the Vasoconstriction Potential (Skin Blanching Effect) of the MC2-01 Cream With Active Comparators and Vehicle
Triamcinolone Acetonide 0.1% Cream
|
1.92 score on a scale
Standard Deviation 0.89
|
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Comparison of the Vasoconstriction Potential (Skin Blanching Effect) of the MC2-01 Cream With Active Comparators and Vehicle
Hydrocortisone Butyrate 0.1% Cream
|
2.06 score on a scale
Standard Deviation 0.70
|
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Comparison of the Vasoconstriction Potential (Skin Blanching Effect) of the MC2-01 Cream With Active Comparators and Vehicle
Desonide 0.05% Cream
|
2.11 score on a scale
Standard Deviation 0.85
|
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Comparison of the Vasoconstriction Potential (Skin Blanching Effect) of the MC2-01 Cream With Active Comparators and Vehicle
Vehicle Cream
|
0.14 score on a scale
Standard Deviation 0.25
|
PRIMARY outcome
Timeframe: Day 2Population: The local tolerance score is presented as number of participants with observed local reaction by trial product and severity.
The local tolerability of the creams will be assesed using a predefined scale: 0 = No reaction; 0.5 = Only slight erythema; 1 = Only erythema; 2 = Erythema with papules or oedema; 3 = Erythema, oedema with papules, oedema with vesicle; 4 = Blisters
Outcome measures
| Measure |
MC2-01 Cream + Comparators
n=36 Participants
Single application of MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream
MC2-01 Cream: Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
|
|---|---|
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Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
MC2-01 Cream · No reaction
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36 Participants
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Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
MC2-01 Cream · Only Slight reaction
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0 Participants
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Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
MC2-01 Cream · Only erythema
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0 Participants
|
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Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
MC2-01 Cream · Erythema with papules or oedema
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0 Participants
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Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
MC2-01 Cream · Erythema, oedema with papules, oedema with vesicle
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0 Participants
|
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Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
MC2-01 Cream · Blisters
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0 Participants
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Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Clobetasol Propionate 0.05% Lotion · No reaction
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36 Participants
|
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Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Clobetasol Propionate 0.05% Lotion · Only Slight reaction
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0 Participants
|
|
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Clobetasol Propionate 0.05% Lotion · Only erythema
|
0 Participants
|
|
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Clobetasol Propionate 0.05% Lotion · Erythema with papules or oedema
|
0 Participants
|
|
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Clobetasol Propionate 0.05% Lotion · Erythema, oedema with papules, oedema with vesicle
|
0 Participants
|
|
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Clobetasol Propionate 0.05% Lotion · Blisters
|
0 Participants
|
|
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Betamethasone Dipropionate 0.05% Cream · No reaction
|
36 Participants
|
|
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Betamethasone Dipropionate 0.05% Cream · Only Slight reaction
|
0 Participants
|
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Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Betamethasone Dipropionate 0.05% Cream · Only erythema
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0 Participants
|
|
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Betamethasone Dipropionate 0.05% Cream · Erythema with papules or oedema
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0 Participants
|
|
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Betamethasone Dipropionate 0.05% Cream · Erythema, oedema with papules, oedema with vesicle
|
0 Participants
|
|
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Betamethasone Dipropionate 0.05% Cream · Blisters
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0 Participants
|
|
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Triamcinolone Acetonide 0.1% Cream · No reaction
|
36 Participants
|
|
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Triamcinolone Acetonide 0.1% Cream · Only Slight reaction
|
0 Participants
|
|
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Triamcinolone Acetonide 0.1% Cream · Only erythema
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0 Participants
|
|
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Triamcinolone Acetonide 0.1% Cream · Erythema with papules or oedema
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0 Participants
|
|
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Triamcinolone Acetonide 0.1% Cream · Erythema, oedema with papules, oedema with vesicle
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0 Participants
|
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Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Triamcinolone Acetonide 0.1% Cream · Blisters
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0 Participants
|
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Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Hydrocortisone Butyrate 0.1% Cream · No reaction
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36 Participants
|
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Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Hydrocortisone Butyrate 0.1% Cream · Only Slight reaction
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0 Participants
|
|
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Hydrocortisone Butyrate 0.1% Cream · Only erythema
|
0 Participants
|
|
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Hydrocortisone Butyrate 0.1% Cream · Erythema with papules or oedema
|
0 Participants
|
|
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Hydrocortisone Butyrate 0.1% Cream · Erythema, oedema with papules, oedema with vesicle
|
0 Participants
|
|
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Hydrocortisone Butyrate 0.1% Cream · Blisters
|
0 Participants
|
|
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Desonide 0.05% Cream · No reaction
|
36 Participants
|
|
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Desonide 0.05% Cream · Only Slight reaction
|
0 Participants
|
|
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Desonide 0.05% Cream · Only erythema
|
0 Participants
|
|
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Desonide 0.05% Cream · Erythema with papules or oedema
|
0 Participants
|
|
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Desonide 0.05% Cream · Erythema, oedema with papules, oedema with vesicle
|
0 Participants
|
|
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Desonide 0.05% Cream · Blisters
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0 Participants
|
|
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Vehicle Cream · No reaction
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36 Participants
|
|
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Vehicle Cream · Only Slight reaction
|
0 Participants
|
|
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Vehicle Cream · Only erythema
|
0 Participants
|
|
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Vehicle Cream · Erythema with papules or oedema
|
0 Participants
|
|
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Vehicle Cream · Erythema, oedema with papules, oedema with vesicle
|
0 Participants
|
|
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Vehicle Cream · Blisters
|
0 Participants
|
Adverse Events
MC2-01 Cream
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clobetasol Propionate 0.05% Lotion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Betamethasone Dipropionate 0.05% Cream
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Triamcinolone Acetonide 0.1% Cream
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hydrocortisone Butyrate 0.1% Cream
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Desonide 0.05% Cream
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vehicle Cream
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The final report, the protocol and the raw date are the exclusive property of the sponsor.
- Publication restrictions are in place
Restriction type: OTHER