Male or female volunteers with known nickel allergy and with healthy skin in the test area, aged 18 years or older
Conditions
Interventions
Product Name: ASF-1075 cream, 2.5 %
Pharmaceutical Form: Cream
Current Sponsor code: ASF-1075
Concentration unit: % percent
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of
Sponsors
Astion Danmark A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 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
Exclusion criteria: • 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; • participation in another clinical trial involving pharmaceutical products in the four weeks preceding the study; • known allergic reactions to components of the study preparations; • 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); • treatment with systemic or locally acting medications which might counter or influence the study aim within two weeks before the beginning of the study (e.g. antihistamines or glucocorticosteroids, ciclosporin); • in the opinion of the investigator or physician performing the initial examination the subject should not participate in the study, e.g. due to probable noncompliance or inability to understand the study and give adequately informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): e primary response measure is the cumulative score sum of the clinical assessment of skin reactions assessed on study days 3 to 7. ;Main Objective: The efficacy of the ASF-1075 creams (2.5 % and 5 %) in the prevention and treatment of contact dermatitis after one pretreatment and four treatments will be assessed. Intraindividual comparison will be made with the active ingredient-free vehicle and a marketed Betamethasone 17- valerate Cream 0.1%.;Secondary Objective: The extent of epidermal barrier impairment measured by TEWL, skin redness measured by chromametry and clinical skin condition evaluated by scoring will be determined. In addition photodocumentation will be performed. | — |
Countries
Germany
Outcome results
None listed