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 24, 2006

Conditionsmale or female patients with chronic hand dermatitis, aged 18 to 70 years MedDRA version: 8.1Level: LLTClassification code 10058898Term: Hand dermatitis

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: male or female patients with chronic hand dermatitis, aged 18 to 70 years
Sponsor: Astion Danmark A/S
Enrollment: 40
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 24, 2006

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Astion Danmark A/S

Eligibility Criteria

Inclusion Criteria

•·men and women aged 18 to 70 years;
•·patients suffering from chronic hand dermatitis rated mild to moderate according to Investigator’s global assessment (score see page 20\) 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;
•·Danish sites: 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, vaginal or transdermal, injection) or intrauterine device (IUD) during the trial and at least 15 days after the end of study.
•·German sites: 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;
•·Danish sites: an epicutan test was performed within the previous 36 month before the first treatment and documented in the patient record;
•·German sites: an epicutan test was performed within the previous 12 month before the first treatment and documented in the patient record;
•·written informed consent obtained.
•Are the trial subjects under 18? no
•Number of subjects for this age range:

Exclusion Criteria

•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;
•metalworkers who are in permanent contact with cutting fluids;
•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 a medical history of skin cancer in the area of the hands or generalized skin cancer;
•patients known to be drug\-resistant for this indication;
•evidence of drug or alcohol abuse;