Dermatitis, Atopic Clinical Trial
Official title:
Determining Effects of Superfine Sheep Wool in INfantile Eczema (DESSINE 2): a Multicentre Randomized Crossover Study
The study is a sequentially recruited, cross-over-cohort, outpatient-based evaluation of the effectiveness of wool clothing, as compared to standard clothing, in reducing the severity of childhood atopic dermatitis (eczema) over two consecutive six-week periods.
The study will aim for a sample size of approximately 150 participants (equally distributed between 3 international sites) between the ages of 3 months and 5 years referred to the respective Dermatology Departments for management of moderate to severe atopic dermatitis. They will be sequentially recruited and randomized to the wool-to-standard clothing arm or standard clothing-to-wool arm. The study will run for 12 weeks for each participant with two consecutive 6-week periods for each intervention, either of wool followed by standard clothing or standard followed by wool clothing. Participants will be assessed by a blinded trained researcher, at their initial appointment, 3 weeks, 6 weeks, 9 weeks and 12 weeks post commencement of the first intervention. The primary outcome is the severity of atopic dermatitis at 6 weeks post commencement of each intervention i.e.at week 6 and week 12. Severity of atopic eczema will be measured using the Eczema Area and Severity Index (EASI). Secondary outcomes include the severity and change in the severity of eczema using the EASI at 3 weeks, the validated Investigators Global Assessment for atopic dermatitis (vIGA-ADâ„¢) score and quality of life assessment using the children's Dermatology Life Quality Index (cDLQI) at 3 and 6 weeks of each 6 week intervention period, as well as weekly Patient Oriented SCORing Atopic Dermatitis index (PO-SCORAD) scores. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03563066 -
Effect of Benralizumab in Atopic Dermatitis
|
Phase 2 | |
Terminated |
NCT04086121 -
A Study to Test the Long-term Safety of BI 655130 in Patients With Atopic Eczema Who Took Part in Study 1368-0032
|
Phase 2 | |
Completed |
NCT04635072 -
Stabilized Whole Rice Bran (SWRB) for Mild to Moderate Atopic Dermatitis
|
Early Phase 1 | |
Completed |
NCT02916888 -
A Study Comparing the Quality of Life of Patients in the Treatment of Eczema by Pediatric Generalists and Specialists
|
N/A | |
Completed |
NCT01945086 -
A Study of Ustekinumab (STELARA®) in Adult Japanese Participants With Severe Atopic Dermatitis
|
Phase 2 | |
Completed |
NCT00541255 -
A Long-Term Examination of Asthma From Childhood Through Adolescence
|
||
Terminated |
NCT04990440 -
A Study of Bermekimab for the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis
|
Phase 2 | |
Completed |
NCT02900131 -
Efficacy, Safety and Dose Finding Trial of Topical Jaungo Application in Atopic Dermatitis Patients
|
Phase 2 | |
Completed |
NCT03568136 -
Investigation of Efficacy of Secukinumab in Patients With Moderate to Serve Atopic Dermatitis
|
Phase 2 | |
Recruiting |
NCT01631617 -
Effects of Treatments on Atopic Dermatitis
|
Phase 2 | |
Completed |
NCT03672383 -
Functional Study to Investigate the Efficacy of a New Medical Device (Modified Diprobase Formulation)
|
N/A | |
Completed |
NCT03634345 -
Drug Drug Interaction Study Evaluating the Effect of Fluvoxamine or Fluconazole on PK and Safety of PF-04965842.
|
Phase 1 | |
Enrolling by invitation |
NCT04761978 -
Efficacy and Tolerance of JAK Inhibitors in ATU for Atopic Dermatitis
|
||
Completed |
NCT03663673 -
Effect of Different Skin Creams on TEWL
|
Phase 1 | |
Recruiting |
NCT05177744 -
Toxicity of Micro and Nano Plastics Combined With Environmental Contaminants on the Risk of Allergic Disease
|
||
Completed |
NCT03720470 -
Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy
|
Phase 3 | |
Completed |
NCT02637206 -
Skin Irritation Study of GSK2894512 Cream
|
Phase 1 | |
Completed |
NCT05544591 -
Evaluation of 611 in Chinese Adults With Moderate to Severe Atopic Dermatitis
|
Phase 2 | |
Completed |
NCT05094700 -
A Study of a Polymeric Surfactant Technology Cleanser in Sensitive Skin Participants
|
N/A | |
Completed |
NCT02590289 -
A Pharmacokinetic Study to Evaluate BBI-5000 Capsules and Food Effect in Healthy Adult Subjects
|
Phase 1 |