Evaluation of the Vasoconstriction Properties of MC2-01 Cream
Condition: Vasoconstriction
Intervention: MC2-01 Cream; Clobetasol Propionate 0.05% Lotion; Betamethasone Dipropionate 0.05% Cream; Triamcinolone Acetonide 0.1% Cream; Hydrocortisone Butyrate 0.1% Cream; Desonide 0.05% Cream; Vehicle
Intervention description: Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation; Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation; Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation; Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation; Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation; Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation; Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Hydrocortisone; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Clobetasol; Desonide; Hydrocortisone-17-butyrate; Betamethasone sodium phosphate; Triamcinolone diacetate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single application, intra individual comparison on mini-test sites (n=7)
Masking: Single (Outcomes Assessor)
Masking description: Visual assessments of potential skin blanching will be made independently by 2 trained observers, according to a grading scale (0 to 4)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of this trial is to compare the vasoconstriction potential
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects aged 18 years to 50 years old having signed and dated an
             informed consent,

          2. Non-smoker subjects,

          3. 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)),

          4. Subjects without signs of skin irritation/disease/disorders/symptoms or blemishes on
             test sites (e.g. erythema, dryness, roughness, scaling, scars, moles, sunburn),

          5. Female subjects of non-childbearing potential defined as surgically sterile or
             post-menopausal (at least one year post cessation of menses),

          6. 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,

          7. Female subjects of childbearing potential must have a negative urine pregnancy test at
             screening visit and at Day 1 to continue,

          8. Subjects willing and able to follow all the trial procedures and complete the whole
             trial,

          9. Subjects affiliated to a social security system.

        Exclusion Criteria:

          1. Female subjects who are breastfeeding,

          2. Use of topical corticosteroids on the test areas (forearms) within 4 weeks prior to
             the screening phase,

          3. 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,

          4. 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,

          5. 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,

          6. Subjects with a history of drug or alcohol abuse/addiction.

          7. 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),

          8. Subjects with obvious difference in skin color between arms,

          9. 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,

         10. 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),

         11. Known or suspected hypersensitivity to any component(s) of Investigational Medical
             Product (IMP),

         12. Subjects with current participation in any other interventional clinical, based on
             interview of the subject,

         13. 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,

         14. Previously enrolled in this clinical trial,

         15. Subjects who do not accept to avoid strenuous physical activity nor alcohol intake
             during the study.

         16. 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),

         17. 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,

         18. Subjects impossible to contact in case of emergency,

         19. Subjects who are in an exclusion period in the National Biomedical Research Register
             of the French Ministry of Health at randomization,

         20. Subjects under guardianship, hospitalized in a public or private institution, for a
             reason other than the research or subject deprived of freedom.