A Study Evaluating the Safety and Efficacy of QGE031 in Atopic Dermatitis Patients
Atopic DermatitisThe study will assess the safety and efficacy of QGE031 in the treatment of moderate to severe atopic dermatitis patients. In addition, QGE031 levels in the blood will be measured and the effect of QGE031 on markers in the blood and skin will be evaluated. Comparisons of the effect of QGE31 will be made with placebo and also cyclosporine, a treatment already established as being effective in atopic dermatitis.
Phase 2 Study of HL-009 Liposomal Gel to Treat Mild to Moderate Atopic Dermatitis
Mild to Moderate Atopic DermatitisThe objective of this phase 2 study is to evaluate the safety and efficacy of HL-009 Liposomal Gel in adult patients with mild to moderate atopic dermatitis (AD).
Photophoresis Versus Ciclosporine in Severe Atopic Dermatitis
Atopic DermatitisSevere atopic dermatitis (AD) is a recurrent and debilitating disease often requiring systemic immunosuppressive treatment. The efficacy of cyclosporine A (CsA) is well proven but potential side effects are concerning. Several reports point at extracorporeal photopheresis (ECP) as an efficient alternative treatment modality with few and mild side effects. However, no direct comparison between CsA and ECP in the treatment of AD has been performed so far. In this trial we test the hypothesis that ECP is non-inferior to standard treatment with CsA.
WAL 801 CL Dry Syrup in Paediatric Atopic Dermatitis Patients
DermatitisAtopicStudy to investigate the safety and efficacy of WAL 801 CL Dry Syrup on pruritus associated with paediatric atopic dermatitis in comparison with that of Ketotifen Fumarate Dry Syrup and to confirm the appropriateness of dosage of WAL801 Dry Syrup.
A Randomized, Open-label, Comparative Study to Evaluate an Intermittent Dosing Regimen of Fluticasone...
Skin DiseasesThis is an open-label, randomized, comparative study, including 4 phases: SCREENING, ACUTE, MAINTENANCE and FOLLOW-UP. Subjects will complete the SCREENING phase to check the eligibility within 7 days after they sign the written informed consent form. All eligible subjects will be enrolled in ACUTE phase to receive twice daily Fluticasone propionate (FP) 0.05% cream up to 4 weeks. The efficacy and safety in ACUTE phase will be assessed every 2 weeks up to 4 weeks or until Treatment Success which depends on which time point comes first. Then subject can get into the MAINTENANCE phase receiving either emollient twice daily plus FP 0.05% cream once daily twice a week (Group A), or emollient twice daily (Group B), by 1:1 randomization. The treatment duration in MAINTENANCE phase will be up to 20 weeks. The efficacy and safety in MAINTENANCE phase will be assessed every 4 weeks up to 20 weeks or until AD relapse that depends on which time point comes first. If subjects don't experience relapse during MAINTENANCE phase, subsequent FOLLOW-UP phase applying emollient twice daily won't be longer than another 12 weeks. Total study duration is up to 37 weeks. All subjects receive FP 0.05% cream twice daily up to 4 weeks to all affected sites and any newly occurring sites in ACUTE phase. After randomization in MAINTENANCE phase, subjects either receive emollient twice daily extendedly plus FP 0.05% cream once daily twice a week to all healed sites and any newly occurring sites (Group A), or emollient twice daily extendedly (Group B), up to 20 weeks. In FOLLOW-UP phase, all subjects apply emollient twice daily up to 12 weeks. This study will enrol 120 subjects, and propose at least 80 subjects to be randomized. Study Endpoints/Assessments: Primary endpoint is to observe the median time to the first relapse of AD during MAINTENANCE phase. Secondary endpoints are: Median time to the first relapse of AD during the whole study (including maintenance phase and follow-up phase. Numbers of recurrent patients at the end of MAINTENANCE phase; Numbers of recurrent patients at the end of FOLLOW-UP phase; The effective rates (proportion of "treatment success" patients) during ACUTE phase (V3, W-2±2days;V4, W0±2days ) Evaluate the safety during the whole study duration (ACUTE phase, MAINTENANCE phase, FOLLOW-UP phase respectively); Evaluate visual skin assessment for signs of cutaneous atrophy, epidermal thickening / lichenification and abnormal pigmentation changes during the whole study duration (ACUTE phase, MAINTENANCE phase, FOLLOW-UP phase respectively); The change of Quality of Life (QoL) from baseline at the end of MAINTENANCE phase; The change of Quality of Life (QoL) from baseline at the end of FOLLOW-UP phase; Subjects' post-study evaluation to drugs.
Safety, Tolerability, and PK of AN2728 in Adolescents With Atopic Dermatitis
DermatitisAtopicThe purpose of this study is to investigate the safety, tolerability, and systemic exposure of AN2728 Topical Ointment, 2%, in subjects with atopic dermatitis.
A Study Comparing the Efficacy of Two Topical Steroid Application Regimens in Pediatric Patients...
Atopic DermatitisThe purpose of this study is to investigate the efficacy of two different corticosteroid ointment application regimens for the treatment of eczema (atopic dermatitis).
Single Center Study Using Omalizumab in Subjects With Atopic Dermatitis
Atopic DermatitisA phase 1 single center study in which omalizumab is dosed normally (according to the product insert) in subjects with atopic dermatitis.
A Study of Ustekinumab (STELARA®) in Adult Japanese Participants With Severe Atopic Dermatitis
DermatitisAtopicThe purpose of this study is to assess the safety and effectiveness of 2 doses of ustekinumab compared with placebo (inactive medication) in adult Japanese participants with severe atopic dermatitis.
Bilateral Comparison Study of Elidel 1% and Hylatopic Plus Emollient Foam for the Treatment of Subjects...
EczemaAtopic DermatitisThis is an investigator-blinded, bilateral comparison study in 30 subjects with atopic dermatitis. It is designed to assess and compare the efficacy of Elidel® (pimecrolimus) cream 1% and Hylatopic™ Plus Emollient Foam™ in subjects with atopic dermatitis. Subjects will apply Elidel® (pimecrolimus) cream 1% twice daily for four weeks on a chosen target eczematous area located on one side of the body and then apply Hylatopic™ Plus Emollient Foam™ three times daily on a symmetrical target eczematous area on the opposite side of the body. A randomized list will be created to determine which side the subject applies each medication. Subjects will be consented prior to any study evaluations or procedures. After signing the consent and meeting all inclusion/exclusion criteria, qualified and enrolled subjects will apply study medication (Elidel® and Hylatopic™ Plus Emollient Foam™) to chosen affected areas for four weeks. Photography will be used to record the location of target lesions at the baseline, week two and week four/final visits. Subject's disease status will be assessed by two methods: 1) Physician's Global Assessment (PGA) and 2) Target Lesion Symptom Score (TLSS) (see sections V.B.2 and V.B.3). PGA as well as TLSS will be made at baseline (Day 0), week two (Day 14 +/- 2 days) and week 4/final visit (Day 28 +/- 2days) visits for each of the target lesions. Half scales (i.e. 0.5, 1.5) will not be used. The presence or absence of skin atrophy and telangiectasias will be noted at each study visit as well. Additionally, subjects' self-assessments of their perception of degree of disease and itching severity control will be collected at each visit for each target lesion. This assessment will be made using a four point scale and Itch Severity Scale (visual analogue score) respectively (see section V.B.4). Lastly, subjects will take a Product Preference Survey at week 4/final visit (Day 28 +/- 2days). Parents (or guardians) will moderate Product Preference Surveys for subjects that are younger than 12 years of age.