Atopic Dermatitis
Conditions
Interventions
Product Code: R129160
Pharmaceutical Form: Oral solution
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Sponsors
Barrier Therapeutics nv
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Caucasian, male or female of NO childbearing potential (at least 2 years post-menopausal or undergone successful surgical sterilization at least 1 year before inclusion), aged between 18 and 60 (extremes included) 2. Confirmed diagnosis of atopic dermatitis according to the criteria of Hanifin & Rajka, with active disease and a itch score of at least moderate 3. Subjects willing and eligible to apply 1% hydrocortisone acetate cream and emollient 4. Ability to use visual analog scale 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, or women of childbearing potential
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