subjects with proven nickel allergy
Conditions
Sponsors
Marinomed Biotechnologie GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the following criteria have to be met for inclusion of a subject in the study: • men and women aged 18 years or older; • known nickel allergy (confirmed in a respective test performed by an allergologist, MD); • 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; • female volunteers of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices [IUDs], sexual abstinence or vasectomized partner; • 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: Subjects are to be excluded from the study when one or more of the following conditions are met: • acne, suntan, eczema, visible infections, hyperpigmentation or tattoos in the test fields; • 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 (e.g. psoriasis); • participation in the treatment phase of another clinical study within the last four weeks prior to the first administration of investigational drug in this study; • known allergic reactions to components of the study preparations (e.g. cetylstearyl alcohol and benzyl alcohol); • 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, glucocorticosteroids, acetylsalicylic acid or cromoglycates); • contraindications according to summary of product characteristics: - known hypersensitivity against one of the components (for Flogencyl: ß-aescin and for Linolacort Hydro 1.0 %: hydrocortisone); - specific skin process or skin diseases (e.g. skin tuberculosis, herpes, varicella); - skin reactions after vaccination; • 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; • planned surgical procedure within the time frame of the study; • subject is institutionalized because of legal or regulatory order.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The efficacy of a marketed Aescin formulation in the treatment of allergic contact dermatitis compared to controls;Secondary Objective: ;Primary end point(s): The primary endpoint of the study is to show a significant reduction in area under the curve (AUC) of chromametry by the study preparation compared to the negative control using a two-sided paired t-test. The significance level alpha is 0.05. | — |
Countries
Germany
Outcome results
None listed