VasoconstrictionPhase 1NCT03758365

Evaluation of the Vasoconstriction Properties of MC2-01 Cream

A Phase 1 study testing MC2-01 Cream, Clobetasol Propionate 0.05% Lotion and Betamethasone Dipropionate 0.05% Cream in people with Vasoconstriction, run by MC2 Therapeutics at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this trial is to compare the vasoconstriction potential Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Vasoconstriction
What is being tested?: MC2-01 Cream, Clobetasol Propionate 0.05% Lotion and Betamethasone Dipropionate 0.05% Cream
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: 1 siteFrance
Study dates: 5 Nov 2018to 23 Nov 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female subjects aged 18 years to 50 years old having signed and dated an informed consent,
Non-smoker subjects,
Subjects demonstrating adequate vasoconstriction to Diprolene® cream within 15 days prior to dosing (unoccluded application of Diprolene® cream for 4-6 hours must show a visual score of skin blanching of at least one unit (visual scale (0-4)),
Subjects without signs of skin irritation/disease/disorders/symptoms or blemishes on test sites (e.g. erythema, dryness, roughness, scaling, scars, moles, sunburn),
Female subjects of non-childbearing potential defined as surgically sterile or post-menopausal (at least one year post cessation of menses),
Female subjects of childbearing potential who have been, in the opinion of the Investigator, using an approved method of birth control (e.g. oral contraception pill or patch, intra-uterine devices, contraceptive implants or vaginal rings, condoms, bilateral tubal ligation) at trial entry and agree to continue until the end of the last trial visit,

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Female subjects of childbearing potential must have a negative urine pregnancy test at screening visit and at Day 1 to continue,
Subjects willing and able to follow all the trial procedures and complete the whole trial,
Subjects affiliated to a social security system.

Who cannot join

Female subjects who are breastfeeding,
Use of topical corticosteroids on the test areas (forearms) within 4 weeks prior to the screening phase,
Use of systemic drugs which may interfere with the blanching reaction including, but not limited to, corticosteroids and other vasoactive drugs (nitrates derivatives, antihypertensive, phenylpropanolamine, diphenhydramine, pseudo-ephedrine, antihistamines, non-steroidal anti-inflammatory drug and aspirin/acetylsalicylic acid), within two weeks prior to screening visit,
Use of any other medication would interfere with the trial results, in particular topical drugs applied on the test area within two weeks prior to screening visit,
Subjects having a caffeine (i.e. coffee, cola, soft-drinks containing caffeine) intake greater than 500mg per day (1 cup of coffee contains approximately 85mg of caffeine) within one day prior to screening visit and until the end of the last visit of the test phase,
Subjects with a history of drug or alcohol abuse/addiction.

Show all 20Show fewer

Abnormal pigmentation of the skin or skin type, that could, in any way, confound interpretation of the trail results (skin type V to VI on the Fitzpatrick scale),
Subjects with obvious difference in skin color between arms,
Subjects with any of the following conditions present on the test areas: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, atrophic skin, and striae atrophicae, fragility of skin veins, ichthyosis and ulcers,
Any current systemic or cutaneous disease that could in any way confound interpretation of the trial results (e.g. atopic dermatitis, contact eczema, or psoriasis),
Known or suspected hypersensitivity to any component(s) of Investigational Medical Product (IMP),
Subjects with current participation in any other interventional clinical, based on interview of the subject,
Subjects who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within the last 4 weeks prior to screening phase,
Previously enrolled in this clinical trial,
Subjects who do not accept to avoid strenuous physical activity nor alcohol intake during the study.
In the opinion of the (sub)investigator, subjects who are unlikely to comply with the Clinical Trial Protocol (e.g. alcoholism, drug dependency or psychotic state),
Subjects in close affiliation with the trial personnel (e.g. immediate family member or subordinate), subjects being a member of the clinical trial personnel, or being an employee of the sponsor or a Contract Research Organisation (CRO involved in the trial,
Subjects impossible to contact in case of emergency,
Subjects who are in an exclusion period in the National Biomedical Research Register of the French Ministry of Health at randomization,
Subjects under guardianship, hospitalized in a public or private institution, for a reason other than the research or subject deprived of freedom.

Trial locations and contacts

1 site in 1 country.

France1 site

CPCAD
Nice, 06200

Other trials in France

About this study

Official title: A Randomized, Evaluator Blinded, Within Subject, Single-Centre Evaluation of the Vasoconstriction Properties of MC2-01 Cream, Compared to 5 Other Corticosteroids in Healthy Subjects

The objective of this trial is to compare the vasoconstriction potential

Read the detailed description

The objective of this trial is to compare the vasoconstriction potential (skin blanching effect) of MC2-01 cream with 5 comparators and MC2-01 vehicle using the human skin blanching test (McKenzie-Stoughton's test).

Conditions: Vasoconstriction
Being tested: MC2-01 Cream, Clobetasol Propionate 0.05% Lotion, Betamethasone Dipropionate 0.05% Cream, Triamcinolone Acetonide 0.1% Cream, Hydrocortisone Butyrate 0.1% Cream

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MC2-01 CreamDrug
Also called Calcipotriol + Betamethasone dipropionate cream
Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
Clobetasol Propionate 0.05% LotionDrug
Also called Clobex
Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
Betamethasone Dipropionate 0.05% CreamDrug
Also called Betamethasone Dipropionate
Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
Triamcinolone Acetonide 0.1% CreamDrug
Also called Triamcinolone acetonide
Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
Hydrocortisone Butyrate 0.1% CreamDrug
Also called Locoid® cream
Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
Desonide 0.05% CreamDrug
Also called Desowen® cream
Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
VehicleDrug
Also called Vehicle cream
Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation

Study groups in NCT03758365
Study group	Role	What they receive
MC2-01 Cream	Experimental	Single application of MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream Receives: Drug: MC2-01 Cream
Clobetasol propionate 0.05% lotion	Active comparator	Single application of Clobetasol propionate 0.05%, Receives: Drug: Clobetasol Propionate 0.05% Lotion
Betamethasone dipropionate 0.05% cream	Active comparator	Single application of Betamethasone dipropionate 0.05%, Receives: Drug: Betamethasone Dipropionate 0.05% Cream
Triamcinolone acetonide 0.1% cream	Active comparator	Single application of Triamcinolone acetonide 0.1%, Receives: Drug: Triamcinolone Acetonide 0.1% Cream
Hydrocortisone Butyrate 0.1% cream	Active comparator	Single application of Hydrocortisone Butyrate 0.1% Cream Receives: Drug: Hydrocortisone Butyrate 0.1% Cream
Desonide 0.05% cream	Active comparator	Single application of Desonide 0.05% Receives: Drug: Desonide 0.05% Cream
Vehicle cream	Placebo comparator	Single application of Vehicle Receives: Drug: Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparison of the Vasoconstriction Potential (Skin Blanching Effect) of the MC2-01 Cream With Active Comparators and Vehicle
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.
Measured: Day 2
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
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
Measured: Day 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Nov 201823 Nov 2018

First posted29 Nov 2018
Study start5 Nov 2018
Primary completion23 Nov 2018
Study completion23 Nov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for VasoconstrictionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Single application, intra individual comparison on mini-test sites (n=7)
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03758365
Sponsor's protocol ID: MC2-01-C4
Status last verified: Jan 2020
First submitted: 13 Nov 2018
Last updated: 9 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Single site study

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Evaluator Blinded, Within Subject, Single-Centre Evaluation of the Vasoconstriction Properties of MC2-01 Cream, Compared to 5 Other Corticosteroids in Healthy Subjects
ClinicalTrials.gov ID: NCT03758365
Acronym / sponsor ID: MC2-01-C4
Conditions: Vasoconstriction
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: MC2 TherapeuticsIndustry (pharma, biotech, devices)
Study start: 5 Nov 2018 (actual)
Primary completion: 23 Nov 2018 (actual)
Study completion: 23 Nov 2018 (actual)
First posted: 29 Nov 2018 (actual)
Results: Posted 9 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective of this trial is to compare the vasoconstriction potential

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 7
Model description: Single application, intra individual comparison on mini-test sites (n=7)

Arm	Type	Receives
MC2-01 Cream	Experimental	Drug: MC2-01 CreamSingle application of MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream
Clobetasol propionate 0.05% lotion	Active comparator	Drug: Clobetasol Propionate 0.05% LotionSingle application of Clobetasol propionate 0.05%,
Betamethasone dipropionate 0.05% cream	Active comparator	Drug: Betamethasone Dipropionate 0.05% CreamSingle application of Betamethasone dipropionate 0.05%,
Triamcinolone acetonide 0.1% cream	Active comparator	Drug: Triamcinolone Acetonide 0.1% CreamSingle application of Triamcinolone acetonide 0.1%,
Hydrocortisone Butyrate 0.1% cream	Active comparator	Drug: Hydrocortisone Butyrate 0.1% CreamSingle application of Hydrocortisone Butyrate 0.1% Cream
Desonide 0.05% cream	Active comparator	Drug: Desonide 0.05% CreamSingle application of Desonide 0.05%
Vehicle cream	Placebo comparator	Drug: VehicleSingle application of Vehicle

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Male or female subjects aged 18 years to 50 years old having signed and dated an informed consent,
Non-smoker subjects,
Subjects demonstrating adequate vasoconstriction to Diprolene® cream within 15 days prior to dosing (unoccluded application of Diprolene® cream for 4-6 hours must show a visual score of skin blanching of at least one unit (visual scale (0-4)),
Subjects without signs of skin irritation/disease/disorders/symptoms or blemishes on test sites (e.g. erythema, dryness, roughness, scaling, scars, moles, sunburn),
Female subjects of non-childbearing potential defined as surgically sterile or post-menopausal (at least one year post cessation of menses),

Key exclusion criteria (20 listed)

Female subjects who are breastfeeding,
Use of topical corticosteroids on the test areas (forearms) within 4 weeks prior to the screening phase,
Use of systemic drugs which may interfere with the blanching reaction including, but not limited to, corticosteroids and other vasoactive drugs (nitrates derivatives, antihypertensive, phenylpropanolamine, diphenhydramine, pseudo-ephedrine, antihistamines, non-steroidal anti-inflammatory drug and aspirin/acetylsalicylic acid), within two weeks prior to screening visit,
Use of any other medication would interfere with the trial results, in particular topical drugs applied on the test area within two weeks prior to screening visit,
Subjects having a caffeine (i.e. coffee, cola, soft-drinks containing caffeine) intake greater than 500mg per day (1 cup of coffee contains approximately 85mg of caffeine) within one day prior to screening visit and until the end of the last visit of the test phase,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MC2-01 CreamAlso: Calcipotriol + Betamethasone dipropionate creamSingle application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation	Drug	MC2-01 Cream
Clobetasol Propionate 0.05% LotionAlso: ClobexSingle application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation	Drug	Clobetasol propionate 0.05% lotion
Betamethasone Dipropionate 0.05% CreamAlso: Betamethasone DipropionateSingle application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation	Drug	Betamethasone dipropionate 0.05% cream
Triamcinolone Acetonide 0.1% CreamAlso: Triamcinolone acetonideSingle application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation	Drug	Triamcinolone acetonide 0.1% cream
Hydrocortisone Butyrate 0.1% CreamAlso: Locoid® creamSingle application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation	Drug	Hydrocortisone Butyrate 0.1% cream
Desonide 0.05% CreamAlso: Desowen® creamSingle application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation	Drug	Desonide 0.05% cream
VehicleAlso: Vehicle creamSingle application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation	Drug	Vehicle cream

Primary outcome

Comparison of the Vasoconstriction Potential (Skin Blanching Effect) of the MC2-01 Cream With Active Comparators and Vehicle
Time frame: Day 2
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.
Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
Time frame: Day 2
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

Results and safety

Results posted to the registry on 9 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MC2-01 Cream + Comparators	36	36

Primary outcome: Comparison of the Vasoconstriction Potential (Skin Blanching Effect) of the MC2-01 Cream With Active Comparators and Vehicle

Time frame: Day 2. Mean (Standard Deviation). Unit: score on a scale

Measure	MC2-01 Cream + Comparators n = 36
MC2-01 Cream	1.66 (0.57)
Clobetasol Propionate 0.05% Lotion	3.05 (0.65)
Betamethasone Dipropionate 0.05% Cream	2.45 (0.61)
Triamcinolone Acetonide 0.1% Cream	1.92 (0.89)
Hydrocortisone Butyrate 0.1% Cream	2.06 (0.70)
Desonide 0.05% Cream	2.11 (0.85)
Vehicle Cream	0.14 (0.25)

Population analysed: 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.

Primary outcome: Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle

Time frame: Day 2. Count of participants. Unit: Participants

Measure	MC2-01 Cream + Comparators n = 36
MC2-01 Cream: No reaction	36
MC2-01 Cream: Only Slight reaction	0
MC2-01 Cream: Only erythema	0
MC2-01 Cream: Erythema with papules or oedema	0
MC2-01 Cream: Erythema, oedema with papules, oedema with vesicle	0
MC2-01 Cream: Blisters	0
Clobetasol Propionate 0.05% Lotion: No reaction	36
Clobetasol Propionate 0.05% Lotion: Only Slight reaction	0

Population analysed: The local tolerance score is presented as number of participants with observed local reaction by trial product and severity.

Adverse events

Time frame: AEs were collected/assessed from the time the informed consent form was signed at the screening visit, which could occur up to 14 days prior to the test period, during the 2 day's test period and until the follow-up visit, 15 days following the test period, had occurred. AEs assessed as reasonably possibly related to the trial medication had to be followed until they were resolved or until the medical condition of the subject was stable.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MC2-01 Cream	0 of 36 (0%)	0 of 36 (0%)	0 of 36
Clobetasol Propionate 0.05% Lotion	0 of 36 (0%)	0 of 36 (0%)	0 of 36
Betamethasone Dipropionate 0.05% Cream	0 of 36 (0%)	0 of 36 (0%)	0 of 36
Triamcinolone Acetonide 0.1% Cream	0 of 36 (0%)	0 of 36 (0%)	0 of 36
Hydrocortisone Butyrate 0.1% Cream	0 of 36 (0%)	0 of 36 (0%)	0 of 36
Desonide 0.05% Cream	0 of 36 (0%)	0 of 36 (0%)	0 of 36
Vehicle Cream	0 of 36 (0%)	0 of 36 (0%)	0 of 36

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Single site study

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Catherine QUEILLE-ROUSSEL, MD principal investigator

CPCAD, Centre de Pharmacologie Clinique Appliquée à la Dermatologie

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MC2-01 Cream, Clobetasol Propionate 0.05% Lotion and Betamethasone Dipropionate 0.05% Cream in people with Vasoconstriction, run by MC2 Therapeutics at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of the Vasoconstriction Potential (Skin Blanching Effect) of the MC2-01 Cream With Active Comparators and Vehicle (time frame: Day 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03758365.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.