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Trial registered on ANZCTR


Registration number
ACTRN12618000864224
Ethics application status
Approved
Date submitted
16/05/2018
Date registered
22/05/2018
Date last updated
22/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot study of a customised nanotextile wet garment treatment on moderate and severe atopic dermatitis
Scientific title
A pilot study of a customised nanotextile wet garment treatment on moderate and severe atopic dermatitis
Secondary ID [1] 294897 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
atopic dermatitis 307859 0
Condition category
Condition code
Skin 306901 306901 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: wet wrap therapy with wet wrap garment made of 100% nanopolyester. One garment set consists of a long sleeved shirt and a long pant, which covers the whole body except for head, neck, hands and feet. It comes with sizes for 6-24 month old, 2-5 year old, 5-8 year old, 8-11 year old, 11-14 year old, M size, L size, XL size and XXL size. A photo of patient wearing wet wrap therapy garment (Tubifast garment) can be found in attachment.

Participants will be recruited and issued with the wet wrap garment in dermatology clinic. Dermatology nurses will educate patients on the procedure of wet wrap therapy and instruct them to wear wet wrap garment overnight (4-8 hours) daily at home for 2 weeks.

Garment wearing procedure: 1. Soak wet wrap garment in lukewarm water, gently squeeze until not dripping. 2. After bathing patient, gently pat patient skin dry with towel. 3. Apply moisturizer and topical steroids as prescribed by doctor. 4. Dress patient in one layer of damp wet wrap garment. 5. Apply a dry layer of cloth on top of the wet wrap garment.

Patient will be reviewed on day 7 and day 14 of treatment in clinic and their adherence will be monitored and reminded during the visit.

Intervention code [1] 301210 0
Treatment: Other
Comparator / control treatment
wet wrap therapy with conventional Tubifast wet wrap garment.
Control group
Active

Outcomes
Primary outcome [1] 305892 0
Eczema severity score - SCORAD (SCORing Atopic Dermatitis)
Timepoint [1] 305892 0
7 days and 14 days after commencement of intervention
Primary outcome [2] 305893 0
Eczema patient quality of life index
Timepoint [2] 305893 0
7 days and 14 days after commencement of intervention
Secondary outcome [1] 346926 0
Patient acceptance of the wet wrap garment (discomfort level, limb limitation, hotness, difficulty wearing garment were measured on scale of 0-10 using a questionnaire. This questionnaire is specially designed for this study.(shown as attachment))
Timepoint [1] 346926 0
14 days after commencement of intervention
Secondary outcome [2] 347008 0
Skin infection rate (recorded by dermatologist if noticed during follow up on day 7 and 14)
Timepoint [2] 347008 0
7 days and 14 days after commencement of treatment
Secondary outcome [3] 347009 0
Patient compliance of treatment (assessed by survey form served to patient. This questionnaire is specially designed for this study.(shown as attachment))
Timepoint [3] 347009 0
7 days and 14 days after commencement of treatment

Eligibility
Key inclusion criteria
- outpatient or inpatient patients

- with moderate-to-severe atopic dermatitis (SCORAD index >= 25)
Minimum age
0 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- patients with mild atopic dermatitis (SCORAD index <25)

- patients currently on wet wrap therapy

- patients on immunotherapy or phototherapy treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Based on previous studies on paediatric AD treatment with WWT, the sample size required for the aim of showing difference in disease improvement between two arms (Nanotextile WWT vs Tubifast WWT) is 63 in each group, i.e. 126 patients in total. It will achieve 80% power to detect an effect size of 0.50 (considered moderate) at a significance level (alpha) of 0.05 using a two-sided two-sample t-test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 10406 0
Singapore
State/province [1] 10406 0
Singapore

Funding & Sponsors
Funding source category [1] 299480 0
University
Name [1] 299480 0
AM-ETHOS Duke-NUS Medical Student Fellowship
Address [1] 299480 0
Duke-NUS Medical School, 8 College Road, 169857
Country [1] 299480 0
Singapore
Primary sponsor type
Individual
Name
Ang Seng Bin
Address
Department of Family Medicine, KK Women's and Children's Hospital, 100 Bukit Timah Road, 229899
Country
Singapore
Secondary sponsor category [1] 298782 0
None
Name [1] 298782 0
Address [1] 298782 0
Country [1] 298782 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300387 0
SingHealth Centralised Institutional Review Board (CIRB)
Ethics committee address [1] 300387 0
Singapore Health Services Pte Ltd, 31 Third Hospital Avenue, #03-03 Bowyer Block C, 168753
Ethics committee country [1] 300387 0
Singapore
Date submitted for ethics approval [1] 300387 0
25/01/2017
Approval date [1] 300387 0
20/03/2017
Ethics approval number [1] 300387 0
2017/2061

Summary
Brief summary
Atopic dermatitis (AD) is a chronic inflammatory skin disease which significantly affects the quality of life of affected patient. This is also a negative impact of the well-being of caregivers and financial burden. The main aims of treatment are to maintain skin barrier function, prevent flare-up and early treatment of symptoms which usually includes daily use of emollients with or without topical corticosteroids. Patients with moderate to severe AD may require wet wrap therapy (WWT) which has proven to be effective. However, the application process is tedious and requires multiple layers which may reduce compliance and unsuitable for tropical climate. The low durability of wet wraps also incurred significant financial costs to the patients.

Customised nanotextile garment has been developed for this study. This garment has cooling properties, antibacterial properties to reduce bacterial infection and colonization, ultra-violet protection, breathable and long lasting which is suitable for use in tropical climate and more cost-effective for long-term therapy.

126 patients including 63 children and 63 adults, with moderate to severe atopic dermatitis will be recruited from the dermatology clinic and inpatient ward. They will be randomised into 2 arms with the study group using daily emollients with topical corticosteroids and nanotextile garments for WWT. The control group will use conventional Tubifast garments for WWT .

Patient will be assessed before treatment, at 1 week and 2 weeks after treatment. Photo of lesion will be taken to assess eczema severity using SCORing Atopic Dermatitis (SCORAD) index and also check for any skin infection. Assessment of quality of life will be conducted using Infant Dermatitis Quality of Life and Children’s Dermatology Quality of Life Index for children, Dermatology Quality of life index for adults. Patient survey will also be conducted regarding comfort, convenience etc. to collect patients’ subjective feedback.

We hypothesized that customised nanotextile garment is an effective adjunctive treatment for patients with moderate to severe atopic dermatitis.

Primary objective is the improvement in clinical condition of the atopic dermatitis and quality of life after 2 weeks therapy for wet wrap therapy using customized nanotextile garments, which is non-inferior compared to conventional Tubifast garment WWT.

Secondary objectives include improvement in compliance and infection rate, better patient feedback in terms of comfort and convenience compared to Tubifast garment WWT.
Trial website
Trial related presentations / publications
Public notes
Wet wrap therapy is widely used as an adjunctive treatment for eczema management with minimal adverse events reported. Consents will be taken before patients get recruited.

In this study, babies and infants are included, and the permission to study on them is approved by the ethic committee (CIRB). For paediatric participants, both parent and patient will be involved in consent process.
Attachments [1] 2691 2691 0 0
Attachments [2] 2692 2692 0 0
Attachments [3] 2693 2693 0 0
/AnzctrAttachments/375108-Consent to Photography- SGH.docx (Participant information/consent)
Attachments [4] 2694 2694 0 0
/AnzctrAttachments/375108-Consent to Photography- KKH.docx (Participant information/consent)
Attachments [5] 2695 2695 0 0
Attachments [6] 2696 2696 0 0
Attachments [7] 2697 2697 0 0
Attachments [8] 2698 2698 0 0
Attachments [9] 2699 2699 0 0
Attachments [10] 2700 2700 0 0
/AnzctrAttachments/375108-WWT in Children.pdf (Supplementary information)
Attachments [12] 2702 2702 0 0
/AnzctrAttachments/375108-MX-M464N_20161114_110304.pdf (Supplementary information)
Attachments [13] 2703 2703 0 0
Attachments [14] 2704 2704 0 0
/AnzctrAttachments/375108-Assent Form Template - WWT clean.doc (Participant information/consent)
Attachments [15] 2705 2705 0 0
/AnzctrAttachments/375108-CIRB Approval.pdf (Ethics approval)
Attachments [16] 2714 2714 0 0
Attachments [17] 2733 2733 0 0

Contacts
Principal investigator
Name 83490 0
Dr Ang Seng Bin
Address 83490 0
Department of Family Medicine, KK Women's and Children's Hospital, 100 Bukit Timah Road, 229899
Country 83490 0
Singapore
Phone 83490 0
+65 63941102
Fax 83490 0
+65 62931234
Email 83490 0
Ang.Seng.Bin@kkh.com.sg
Contact person for public queries
Name 83491 0
Miss He Huiling
Address 83491 0
Duke-NUS Medical School, 8 College Road, 169857
Country 83491 0
Singapore
Phone 83491 0
+65 94736820
Fax 83491 0
Email 83491 0
a0133054@u.duke.nus.edu
Contact person for scientific queries
Name 83492 0
Miss He Huiling
Address 83492 0
Duke-NUS Medical School, 8 College Road, 169857
Country 83492 0
Singapore
Phone 83492 0
+65 94736820
Fax 83492 0
Email 83492 0
a0133054@u.duke.nus.edu

No information has been provided regarding IPD availability
Summary results
No Results