Evaluation of the efficacy of a topical formulation containing ASF-1075 in the treatment of chronic hand dermatitis - hand dermatitis

Astion Danmark A/S0 sites40 target enrollmentJanuary 30, 2006

Overview

No summary available.

Registry

who.int

Start Date

January 30, 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 to 70 years;
•patients suffering from chronic hand dermatitis rated mild to moderate according to Investigator’s global assessment and which has persisted for more than 6 month in spite of attempts to identify and remove cause;
•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
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes

•patients with primary hyperkeratotic forms of dermatitis, hand dermatosis other than eczematous dermatoses or with acute infection;
•patients with allergic contact dermatitis if the allergen is identified and they remained in contact with the allergen;
•metalworker;
•Suntan, hyperpigmentation or tattoos in the test fields;
•dark\-skinned persons whose skin color prevents ready assessment of skin reactions;
•treatment within 3 months before study day 1 with systemic medications (i.e. glucocorticoids or immune modulators), treatment within two weeks with topical glucocorticosteroids, or treatment with other systemic or locally acting medications which might counter or influence the trial aim within two weeks before study day 1 and during the study;
•UV\-therapy within 4 weeks before study day 1 and during the study;
•patients with skin cancer in the medical history;
•patients known to be drug\-resistant for this indication;
•evidence of drug or alcohol abuse;