Phase IIa, single-center, randomized, double-blind, vehicle-controlled study to determine the efficacy and safety/tolerability of a topical riluzole formulation in patients with atopic eczema - Atopic eczema
- Conditions
- Subjects with mild to moderate dermatitis meeting Hanafin and Rajka´s Criteria with at least two comparable lesional areas of 20-50 cm2.MedDRA version: 9.1Level: LLTClassification code 10003641Term: Atopic eczema
- Registration Number
- EUCTR2006-006653-27-DE
- Lead Sponsor
- Biofrontera Bioscience GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
All of the following criteria have to be met for inclusion of a volunteer in the study:
• signed written informed consent obtained;
• male or female subjects, 18 to 64 years;
• manifest atopic dermatitis diagnosed according to Hanifin and Rajka (3);
• two comparable lesional areas of 20 - 50 cm2 with a distance of at least 5 cm, clinical condition of atopic eczema mild to moderate;
• TEWL in the lesional areas at least 12 g/m²h, TEWL value differences = 30 % are allowed between both lesional areas;
• the physical examination must be without further disease findings unless the investigator considers an abnormality to be clinically irrelevant;
• sexually active females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective medically accepted contraceptive regimen: systemic contraceptive (combined oral contraceptive, implant, injection), safe intrauterine device (IUD).
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
Subjects are to be excluded from the study when one or more of the following conditions are met:
• acne, suntan, eczema other than Atopic eczema, hyper- or hypopigmentation or tattoos in the treatment areas;
• dark-skinned persons whose skin color prevents ready assessment of skin reactions;
• evidence of drug or alcohol abuse;
• pregnancy or nursing;
• UV-therapy within 6 weeks before first treatment;
• participation in another clinical study involving pharmaceutical products in the 28 days preceding or during the study;
• symptoms of a clinically significant illness that may influence the outcome of the study in the month before and during the study;
• known allergic reactions to components of the study preparations;
• liver disease or transaminase values > 3 times upper normal limit;
• kidney insufficieny;
• neutropenia;
• systemic treatment or locally acting medications which might counter or influence the study aim (e.g. glucocorticosteroids or medication that influences liver function) within four weeks before first study treatment (exception: asthma may be found in subjects with atopic dermatitis, therefore inhalation with corticosteroids in subjects with asthma accompanying atopic dermatitis will be allowed at a dose not exceeding 1 mg/day. The dosage should remain constant throughout the study period);
• 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;
• 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: To assess the clinical skin condition after treatment with a topical riluzole formulation in subjects with atopic eczema;Secondary Objective: ;Primary end point(s): The primary endpoints are<br>• clinical assessment (erythema, edema/infiltrate, excoriations, papules) by scoring<br>• calculation of epidermal barrier impairment by measurement of transepidermal water loss (TEWL)<br>• evaluation of skin redness by chromametry<br>• subjective assessment of itching and burning<br>• safety laboratory <br>• evaluation of blood levels of active ingredient<br>
- Secondary Outcome Measures
Name Time Method