Evaluation of the Vasoconstriction Properties of MC2-01 Cream

NCT03758365 | Completed Phase 1 Results FDA Drug

• 1 other identifier: MC2-01-C4
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this trial is to compare the vasoconstriction potential

Conditions

Vasoconstriction

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Day 2

Study Arms (7)

MC2-01 Cream

EXPERIMENTAL

Single application of MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream

Drug: MC2-01 Cream

Clobetasol propionate 0.05% lotion

ACTIVE COMPARATOR

Single application of Clobetasol propionate 0.05%,

Drug: Clobetasol Propionate 0.05% Lotion

Betamethasone dipropionate 0.05% cream

ACTIVE COMPARATOR

Single application of Betamethasone dipropionate 0.05%,

Drug: Betamethasone Dipropionate 0.05% Cream

Triamcinolone acetonide 0.1% cream

ACTIVE COMPARATOR

Single application of Triamcinolone acetonide 0.1%,

Drug: Triamcinolone Acetonide 0.1% Cream

Hydrocortisone Butyrate 0.1% cream

ACTIVE COMPARATOR

Single application of Hydrocortisone Butyrate 0.1% Cream

Drug: Hydrocortisone Butyrate 0.1% Cream

Desonide 0.05% cream

ACTIVE COMPARATOR

Single application of Desonide 0.05%

Drug: Desonide 0.05% Cream

Vehicle cream

PLACEBO COMPARATOR

Single application of Vehicle

Drug: Vehicle

Interventions

MC2-01 Cream DRUG

Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation

Also known as: Calcipotriol + Betamethasone dipropionate cream

MC2-01 Cream

Clobetasol Propionate 0.05% Lotion DRUG

Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation

Also known as: Clobex

Clobetasol propionate 0.05% lotion

Betamethasone Dipropionate 0.05% Cream DRUG

Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation

Also known as: Betamethasone Dipropionate

Betamethasone dipropionate 0.05% cream

Triamcinolone Acetonide 0.1% Cream DRUG

Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation

Also known as: Triamcinolone acetonide

Triamcinolone acetonide 0.1% cream

Hydrocortisone Butyrate 0.1% Cream DRUG

Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation

Also known as: Locoid® cream

Hydrocortisone Butyrate 0.1% cream

Desonide 0.05% Cream DRUG

Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation

Also known as: Desowen® cream

Desonide 0.05% cream

Vehicle DRUG

Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation

Also known as: Vehicle cream

Vehicle cream

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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,
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• MC2 Therapeutics: lead

Study Sites (1)

CPCAD

Nice, 06200, France

Location

MeSH Terms

Interventions

calcipotriene; Clobetasol; betamethasone-17,21-dipropionate; Triamcinolone Acetonide; hydrocortisone-17-butyrate; Desonide

Intervention Hierarchy (Ancestors)

Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Triamcinolone; Pregnadienes; Pregnanes; Pregnadienetriols

Results Point of Contact

• Title: Birgitte Vestbjerg
• Organization: MC2 Therapeutics

bve@mc2therapeutics.com

+45 2077 2575

Study Officials

• Catherine QUEILLE-ROUSSEL, MD

  CPCAD, Centre de Pharmacologie Clinique Appliquée à la Dermatologie

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Visual assessments of potential skin blanching will be made independently by 2 trained observers, according to a grading scale (0 to 4)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single application, intra individual comparison on mini-test sites (n=7)

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 29, 2018
• Study Start: November 5, 2018
• Primary Completion: November 23, 2018
• Study Completion: November 23, 2018
• Last Updated: January 9, 2020
• Results First Posted: January 9, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)