subjects with proven type I allergy against one of the three allergens: grass pollen, tree pollen, cat epithelia MedDRA version: 12.1 Level: LLT Classification code 10036019 Term: Pollen allergy MedDRA version: 12.1 Level: LLT Classification code 10066093 Term: Birch pollen allergy MedDRA version: 12.1 Level: LLT Classification code 10001742 Term: Allergy to animal
Conditions
Sponsors
Marinomed Biotechnologie GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •men and women aged 18 – 64 years with a proven typ-I allergy against the corresponding allergen (grass pollen, tree pollen [birch, alder, hazel] or cat epithelia); •the physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the clinical trial; •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) no 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; •dark-skinned persons whose skin color prevents ready assessment of skin reactions; •acute allergic symptoms; •known allergy to parabens; •with anamestics indication for anaphylaxis or bronchial asthma wich is not well adjusted (FEV < 70%); •dermographism; •evidence of drug or alcohol abuse; •pregnancy or nursing; •planned surgical procedure within the time frame of the trial; •symptoms of a clinically significant illness that may influence the outcome of the trial in the four weeks before and during the trial; •participation in the treatment phase of another clinical trial within the last four weeks prior to the first administration of investigational product in this clinical trial; •treatment with systemic or locally acting medications which might counter or influence the trial aim within four weeks before the baseline visit and during the trial (e.g. antihistamines or glucocorticosteroids); •contraindications according to summary of product characteristics: o known hypersensitivity against one of the components (for Flogencylâ: ß-aescin, for FenistilÒ Gel: Dimethindene maleate, and for AdvantanÒ Creme: Methylprednisolone aceponate); o specific skin process or skin diseases (e.g. skin tuberculosis, herpes, varicella) (for AdvantanCreme); o skin reactions after vaccination (for AdvantanÒ Creme); •in the opinion of the investigator or physician performing the initial examination the subject should not participate in the clinical trial, e.g. due to probable noncompliance or inability to understand the trial and give adequately informed consent; •subject is institutionalized because of legal or regulatory order.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Subjective assessment of the efficacy of a marketed Aescin formulation in reducing itch 20 ± 2 minutes after experimentally induced itch compared to an untreated test field ;Secondary Objective: -To assess the efficacy of a marketed Aescin formulation in reducing wheal and flare reactions 20 ± 2 minutes after experimentally induced wheal and flare reactions compared to an untreated test field. -To assess the efficacy of a marketed Aescin formulation in reducing itch, wheal and flare reactions 20 ± 2 minutes after experimentally induced itch, wheal and flare reactions compared to two references. -Subjective Assessment of the benefit by ranking all four test fields from 1 – 4, 30 + 15 minutes after experimentally induced itch, wheal and flare reactions. ;Primary end point(s): The primary endpoint of the study is the subjective assessment of the efficacy of a marketed Aescin formulation in reducing itch 20 minutes after experimentally induced itch compared to an untreated test field using a 10 point scale. | — |
Countries
Germany
Outcome results
None listed