Assessment of the activity of a new cream containing betamethasone dipropionate at 0.010%, 0.025% and 0.050% versus reference products using a vasoconstriction assay in healthy subjects.

Pierre Fabre Dermatologie represented by Institut de Recherche Pierre Fabre0 sites40 target enrollmentMarch 16, 2009

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Topical treatment of inflammatory dermatosis linked to cutaneous dryness
Sponsor: Pierre Fabre Dermatologie represented by Institut de Recherche Pierre Fabre
Enrollment: 40
Status: Active, not recruiting
Last Updated: 7 years ago

No summary available.

Registry

who.int

Start Date

March 16, 2009

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Pierre Fabre Dermatologie represented by Institut de Recherche Pierre Fabre

•The subjects must fulfil all the following criteria to enter the study:
•1\.Female or male healthy subject.
•2\.Subject aged between 18 and 50 years old.
•3\.Subject with skin type II to IV on the Fitzpatrick scale
•4\.Subject non smoking or smoking less than 5 cigarettes/day.
•5\.Subjects demonstrating adequate vasoconstriction to topical corticosteroids ( i.e. responders) Diprosone® cream (non\-occlusive application of the reference for 4\-6 hours screening pre\-test must show a visual score of at least one unit (visual scale (0\-4\)).
•6\.Subject’s condition allowing accurate evaluations and study procedures, at the own Investigator’s judgment (e.g. non\-excessive hair on tested areas).
•7\.For women:
•7\.1\.of childbearing potential who practices an effective method of contraception for at least 2 months before the study and one month after the end of the study and during the study with one of the following methods: oral contraception, Intra Uterine Device, injectable or implantable contraception;
•7\.2\.of childbearing potential who has a negative urinary pregnancy test before final enrolment;

•The subjects who present at least one of the following criteria will not be allowed to enter the study:
•1\.Pregnant women, nursing mother, or female planning a pregnancy.
•2\.Any systemic disorder (e.g. clinically significant hypertension or circulatory disease), following Investigator judgment that may interfere with interpretation of the study results.
•3\.Any skin disease on tested areas, (e.g. active atopic dermatitis, known contact dermatitis, psoriasis, any type of skin infection, ulcer lesion), that may interfere with interpretation of the study results.
•4\.Subject with known sensitivity to topical drugs related to any component of any of the formulations being tested (for list of product ingredients see Investigational Brochure and Package insert for marketed corticosteroids).
•5\.Subject who takes treatment acting on vascular tone (e.g. nitrates derivatives, antihypertensives antihistamines, OTC cough/cold products containing antihistamines and/or either phenypropanolamine or phentolamine etc).
•6\.Subject with any obvious difference in colour between arms.
•7\.Subject who takes more than 500 mg of caffeine per day prior to or during the study (a cup of coffee contains about 85 mg of caffeine).
•8\.Subject who would require shaving ventral forearms to insure consistent dose on skin surface.
•9\.Subject with clinically significant history of alcoholism or drug abuse.