atopic dermatitis MedDRA version: 9.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis
Conditions
Sponsors
Avontec GmbH
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: ? Male, aged between 18 to 75 years ? Subjects must have a diagnosis of mild to moderate atopic dermatitis (IGA > 1 and 2 symmetrical eczema areas on the extremities each of at least 12 cm2 with a modified EASI severity score of the test area (sum of erythema, induration/population, excoriation and lichenification) > 6 and > 60 % afflicted with atopic dermatitis ? Written informed consent 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: ? Any condition other than atopic dermatitis (and related disorders) or treatment that may interfere with the skin barrier function ? Significant medical condition or treatment that may have an influence on the immune response (e.g. auto immune measures) ? Screening laboratory values > Grade 1 (according to WHO Toxicity Criteria by Grade) ? Administration of any biologic within 3 months prior to study entry ? Administration of any other systemic drugs for atopic dermatitis (e.g. corticosteroids, cyclosporine) within 30 days prior to study entry ? Administration of any topical drugs for atopic dermatitis (e.g. glucocorticoseroids, calcineurin inhibitors) within 14 days prior to study entry ? Administration of antihistamines within 7 days prior to study entry ? Phototherapy (e.g. UVB, PUVA) within 14 days prior to study entry ? Administration of any topical anti-inflammatory drug within 14 days prior to study entry ? Clinically relevant co-morbidity ? Known adverse reactions of any severity or hypersensitivity to any ingredient of 2% AVT-02 UE ointment (including Unguentum emulsificans) ? History or presence of malignant disease (other than surgically removed b-cell carcinoma) and/or auto immune diseases (e.g. multiple sclerosis) ? Immunotherapy prior to and during the study ? Blood donation and loss of more than 400 ml 8 weeks prior to inclusion into study ? HIV infection (has to be excluded by laboratory test prior to randomization) ? Other active infectious diseases ? Major surgery 4 weeks prior to inclusion into study ? Vaccination with 6 days prior to enrolment and during the study ? Excessive UV-exposure 4-weeks prior to enrolment and during the conduct of the study ? Subjects with partner of child-bearing potential and their partners should use barrier contraception e.g. condoms. The partners of subjects should also use a highly effective method of birth control (failure rate < 1% per year), such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.barrier methods of contraception such as condoms, diaphragm, or the cervical cap. ? Subjects who are – in the opinion of the investigator – unreliable, and/or non-compliant, and/or who present with any condition or treatment (including cosmetic products) that may interfere with the conduct of the trial ? Participation in any other clinical trial within 4 weeks prior or during this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the efficacy and safety of 2% AVT-02 UE ointment in subjects with atopic dermatitis compared to placebo as assessed by modified EASI of marker areas and safety data during a 4 weeks treatment.;Secondary Objective: The secondary objective is to evaluate the efficacy and tolerability as assessed by IGA, modified EASI50, physicians’ and subjects’ assessment of tolerability, laboratory parameter, AEs and photo documentation (selected site only) as well as (for a subset of 35 subjects) by immune histological markers in skin biopsies. PK measures will be performed in 8 subjects.;Primary end point(s): The primary efficacy endpoint is change compared to baseline in the modified EASI at week 4. The endpoint will be compared between the two treatment groups using the Student’s t-test for related samples at <0.05 level of significance. | — |
Countries
Germany
Outcome results
None listed