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

Phase 1

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

Registration Number: EUCTR2005-005793-75-DE

Lead Sponsor: Astion Danmark A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

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:
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
F.1.3.1 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;
•pregnancy or nursing;
•symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before study day 1 and during the study;
•participation in another clinical trial involving pharmaceutical products in the four weeks before study day 1;
•known allergic reactions to components of the study preparations;
German sites: known allergic reactions with symptoms as asthma, allergic rhinitis or urticaria to 2-acetoxy benzoic acid (acetyl salicylic acid) or other non-steroidal antirheumatics (because of possible cross allergic reactions);
•in the opinion of the investigator or physician performing the initial examination the patient should not participate in the study, e.g. due to probable noncompliance or inability to understand the study and give adequately informed consent.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of a topical ASF-1075 formulation and the corresponding active ingredient-free vehicle in the treatment of chronic hand dermatitis;Secondary Objective: ;Primary end point(s): The primary endpoint is the clinical assessment of skin condition using the HECSI (hand eczema severity index)<br><br>

Secondary Outcome Measures

Name	Time	Method

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