Efficacy and Safety Study of Apremilast in Subjects With Moderate to Severe Atopic Dermatitis
DermatitisAtopic DermatitisA study to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe atopic dermatitis
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.
Open-label Study of Dupilumab in Patients With Atopic Dermatitis
Atopic DermatitisThe primary objective is to assess the long-term safety of dupilumab administered in adult participants with atopic dermatitis (AD). The secondary objective of the study is to assess the immunogenicity of dupilumab in adult participants with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment. Optional Sub-Study: The primary objective of the sub-study is to assess the safety of the new dupilumab drug product in adult patients with AD after switching from the current dupilumab drug product. The secondary objectives of the sub-study are to evaluate systemic exposure and immunogenicity of the new dupilumab drug product in adult patients with AD.
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.
Efficacy and Tolerability Study of Device, RD047-26 for the Treatment of Mild to Moderate Atopic...
Atopic DermatitisPruritusThe purpose of this study is to find out if investigational device, RD047-26, is safe and useful for the treatment of mild to moderate atopic dermatitis.
Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Atopic Dermatitis...
Atopic DermatitisPrimary Objective: To evaluate safety (4 weeks) Secondary Objectives: To evaluate the long-term safety (12 weeks) To evaluate the efficacy To characterize the pharmacokinetic profile
A Safety, Tolerability and Pharmacokinetic Study of LEO 29102 in Subjects With Atopic Dermatitis...
Atopic DermatitisThe purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of 7 days treatment with LEO 29102 in adult patients with atopic dermatitis.
The Effectiveness of Montelukast on Atopic Dermatitis in Koreans
Atopic DermatitisThe purpose of this study is to assess the clinical effectiveness of Montelukast in children (2~6 years old) with atopic dermatitis and identify the pathophysiologic background of Montelukast on the role of modulating the atopic dermatitis measured by urinary Leukotriene 4 (LTE4) and Eosinophil protein X(EDN).
Treatment and Control of Atopic Dermatitis With 0.1% Tacrolimus Ointment
DermatitisAtopicLong-term tacrolimus ointment based regimen comprising of up to 6 weeks of initial twice daily treatment and subsequent twice weekly prophylactic application can effectively treat active lesions of atopic dermatitis and prevent delay & reduce flares