NCT03758365

Evaluation of the Vasoconstriction Properties of MC2-01 Cream

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: MC2 Therapeutics · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The objective of this trial is to compare the vasoconstriction potential

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

Interventions

Type	Name	Description
DRUG	MC2-01 Cream	Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
DRUG	Clobetasol Propionate 0.05% Lotion	Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
DRUG	Betamethasone Dipropionate 0.05% Cream	Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
DRUG	Triamcinolone Acetonide 0.1% Cream	Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
DRUG	Hydrocortisone Butyrate 0.1% Cream	Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
DRUG	Desonide 0.05% Cream	Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
DRUG	Vehicle	Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation

Timeline

• Start date: 2018-11-05
• Primary completion: 2018-11-23
• Completion: 2018-11-23
• First posted: 2018-11-29
• Last updated: 2020-01-09
• Results posted: 2020-01-09

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated drug study