Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04011215
Other study ID # 2019.034
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 23, 2019
Est. completion date October 2024

Study information

Verified date October 2023
Source Murdoch Childrens Research Institute
Contact John C Su, FACD, FRACP
Phone +61393871000
Email john.su@mcri.edu.au
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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-AD™) 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date October 2024
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 3 Months to 5 Years
Eligibility Inclusion Criteria: - Is aged between 3 months and 5 years of age at the time of recruitment - Has moderate to severe eczema as determined by an EASI score of 7 or above at their initial visit - Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participants behalf Exclusion Criteria: - Has a known allergic contact dermatitis to wool or merino wool - Is unable to attend all scheduled visits - Has unstable eczema defined by an escalation of treatment requirements during the preceding 6 weeks. This would include flares of AD for any reason including infection, food allergy etc. - Use of systemic corticosteroids within 6 weeks of study start. - Any medical reason that is considered by the principal investigator to preclude enrolment.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
wool clothing
superfine merino wool ensembles for baby/child wear
standard clothing
Standard clothing refers to the clothing normally worn by the infant/child. This will not be superfine merino wool as superfine merino is not generally available for baby wear. The exact nature of the standard clothing will be recorded by investigators. From previous data we expect it to be primarily cotton.

Locations

Country Name City State
United States Northwestern University, Skin Disease Research Center, Lurie Children's Hospital Chicago Illinois

Sponsors (4)

Lead Sponsor Collaborator
Murdoch Childrens Research Institute Australian Wool Innovation Ltd, Northwestern University, United Christian Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Su JC, Dailey R, Zallmann M, Leins E, Taresch L, Donath S, Heah SS, Lowe AJ. Determining Effects of Superfine Sheep wool in INfantile Eczema (DESSINE): a randomized paediatric crossover study. Br J Dermatol. 2017 Jul;177(1):125-133. doi: 10.1111/bjd.15376. Epub 2017 Jun 12. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Eczema Area and Severity Index (EASI) blinded assessor administered EASI (units on a scale), will assess change from baseline. A score is obtained ranging from 0-72 based on erythema, papulation, excoriation and lichenification, each graded 0-3 for each of four body regions (head and neck, upper limbs, trunk, lower limbs) that are weighted according to surface area representation. A higher number indicates increased severity. week 3 of each 6 week period (ie week 6 and 12)
Secondary Eczema Area and Severity Index (EASI) blinded assessor administered EASI (units on a scale), will assess change from baseline. week 3 of each 6 week period (ie week 3 and 9)
Secondary validated Investigators Global Assessment for atopic dermatitis (vIGA-AD™) score blinded assessor administered vIGA-AD™ score (units on a scale), will assess change from baseline. This score assesses erythema, induration/papulation, lichenification and oozing/crusting on ascale of 0 to 4. A high score reflects greater severity. week 3, 6, 9, 12
Secondary children's Dermatology Life Quality Index (cDLQI) patient administered cDLQI questionnaire (units on a scale), will assess change from baseline. Ten questions are each scored from 0 to 3, the total score ranging from 0-30. A higher score reflects greater impairment of quality of life. week 3, 6, 9, 12
Secondary Patient Oriented SCORing Atopic Dermatitis score (PO-SCORAD) patient completed PO-SCORAD score (units on a scale). It measures global severity using a scale ranging from 0 to 103, based on disease extent, six morphological parameters and two subjective markers (itch and sleep disturbance). High scores reflect greater severity. weekly over 12 weeks
Secondary Topical medication use questionnaire (number of times per day medication is applied; the name and strength of medication will be noted). This will be compared with baseline use. daily over 12 weeks
Secondary Topical moisturiser use questionnaire to determine number of times per day moisturiser is applied. This will be compared with baseline use. weekly over 12 weeks
See also
  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
Terminated NCT02582788 - Bathing Additives in Pediatric Atopic Dermatitis N/A