Dermatitis, Atopic Clinical Trial
— DESSINE2Official 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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University, Skin Disease Research Center, Lurie Children's Hospital | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Murdoch Childrens Research Institute | Australian Wool Innovation Ltd, Northwestern University, United Christian Hospital |
United States,
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
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 |
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