Atopic Dermatitis
Conditions
Sponsors
Barrier Therapeutics nv
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Caucasian, male or female, aged between 18 and 65 (extremes included) 2. Women of childbearing potential must have a negative urine pregnancy test at screening, must have used a highly effective stable form of birth control (with a failure rate of less than 1%) for at least one month prior to screening and must agree to remain on this effective form of birth control until the first menses after 30 days following the end of study medication treatment. This effective form of birth control consists of oral contraceptives or a contraceptive implant or a depot injection or a contraceptive patch or an IUD 3. In addition, women of childbearing potential should use a double barrier method (one of the methods mentioned above under item 6 together with a condom and spermicidal agent or a diaphragm and spermicidal agent) from inclusion up to 7 days after end of treatment 4. Confirmed diagnosis of atopic dermatitis according to the criteria of Hanifin & Rajka, with active disease and an itch score of at least moderate (see 3.4.1.2 Physician’s evaluation of itch) 5. Subjects willing and eligible to apply 1% hydrocortisone acetate cream and emollient during the entire course of the study 6. Ability to use visual analog scale and to complete the diary 7. Availability of signed informed consent prior to beginning protocol-specific procedures, indicating an understanding of the purpose of this trial and a willingness to adhere to the treatment regimen and trial procedures described in this protocol 8. In good general health and free of any disease state or physical condition which, in the investigator’s opinion, exposes the subject to an unacceptable risk by study participation 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: 1. History of drug allergy to antihistamines, other anti-allergic compounds, quinine or any of the components of the study medication 2. History or suspicion of alcohol and/or drug abuse 3. Subjects having following concomitant disorders: significant hepatic, renal or bone marrow diseases, severe neuropathy including multiple sclerosis, significant psychiatric disorders or any other serious disease (including cancer and subjects known to be HIV positive), significant infection that requires systemic antibiotic treatment 4. Any disease state or physical condition that, in the investigator’s opinion, may impair evaluation of itch and/or the atopic dermatitis lesions, or may interfere with the treatment 5. Out-of-range laboratory test results that the investigator considers as pathologic 6. History of heart failure, myocardial infarction within the past six months, cardiac arrhythmia, or under treatment for heart disorders. 7. Clinically significant abnormal ECG-intervals or morphology of the ECG; QT or QTc >470 ms in females or >450 ms in males. 8. Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the effect of the IMP on the itch, associated with atopic dermatitis;Secondary Objective: Evaluate the effect of the IMP on the atopic dermatitis lesions;Primary end point(s): The primary efficacy variable is the change from baseline in itch score at visit 3, as scored by the investigator. | — |
Countries
Belgium, Czech Republic
Outcome results
None listed