A phase II, single-center, randomized, controlled, observer-blind study with intra-individual comparisons within two parallel groups to assess the efficacy of a topical Aescin formulation in the treatment of allergic contact dermatitis
- Conditions
- subjects with proven nickel allergy
- Registration Number
- EUCTR2009-009379-36-DE
- Lead Sponsor
- Marinomed Biotechnologie GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method