A phase IIa, single-center, randomized, reference-controlled, observer-blind trial to assess the efficacy of a topical Aescin formulation in experimentally induced itch, wheal and flare reactions in patients with type-I allergy

• Conditions: subjects with proven type I allergy against one of the three allergens: grass pollen, tree pollen, cat epithelia; MedDRA version: 12.1Level: LLTClassification code 10036019Term: Pollen allergy; MedDRA version: 12.1Level: LLTClassification code 10066093Term: Birch pollen allergy; MedDRA version: 12.1Level: LLTClassification code 10001742Term: Allergy to animal

• Registration Number: EUCTR2010-019373-15-DE
• Lead Sponsor: Marinomed Biotechnologie GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-23
• Last Update Posted: 18 February 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified