Evaluation of the efficacy of topical formulations containing ASF-1075 in the prevention and treatment of contact dermatitis - contact dermatitis

Astion Danmark A/S0 sites20 target enrollmentJanuary 12, 2006

Overview

No summary available.

Registry

who.int

Start Date

January 12, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Astion Danmark A/S

•men and women aged 18 years or older;
•known nickel allergy (confirmed by an allergy\-pass), the epicutan test for confirmation of the nickel allergy is not older than 5 years;
•allergic reactions against nickel within the last five years;
•healthy skin on which reddening can be easily recognized in the area of the test fields;
•the physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study;
•sexually active females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide, intrauterine device (IUD), condom with intravaginal spermicide;
•written informed consent obtained.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•acne, suntan, eczema, hyperpigmentation or tattoos in the test fields;
•angry back;
•allergic reactions to nickel during the last six weeks;
•generalized allergic reactions to nickel during the last five years;
•subjects with atopic dermatitis;
•UV\-therapy within 4 weeks before study day 1 and during the study;
•dark\-skinned persons whose skin color prevents ready assessment of skin reactions;
•evidence of drug or alcohol abuse;
•pregnancy or nursing;
•symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;