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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
Sex
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
23/03/2017
Date of last participant enrolment
Anticipated
31/12/2018
Actual
Date of last data collection
Anticipated
14/01/2019
Actual
Sample size
Target
126
Accrual to date
60
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
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
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
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2691 2691 0 0
/AnzctrAttachments/375108-Participant Information Sheet and Informed Consent Template - WWT (parent) clean KKH.doc (Participant information/consent)
Attachments [2] 2692 2692 0 0
/AnzctrAttachments/375108-Participant Information Sheet and Informed Consent Template - WWT (adult) clean SGH.doc (Participant information/consent)
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
/AnzctrAttachments/375108-Patient feedback form.docx (Other)
Attachments [6] 2696 2696 0 0
/AnzctrAttachments/375108-DLQI- modified.doc (Other)
Attachments [7] 2697 2697 0 0
/AnzctrAttachments/375108-CDLQI- modified.doc (Other)
Attachments [8] 2698 2698 0 0
/AnzctrAttachments/375108-IDQOL - modified.doc (Other)
Attachments [9] 2699 2699 0 0
/AnzctrAttachments/375108-Efficacy and safety of WWT (critical review).pdf (Supplementary information)
Attachments [10] 2700 2700 0 0
/AnzctrAttachments/375108-WWT in Children.pdf (Supplementary information)
Attachments [11] 2701 2701 0 0
/AnzctrAttachments/375108-AM-ETHOS Duke-NUS Medical Student Fellowship FY2016 [Application Results].docx (Other)
Attachments [12] 2702 2702 0 0
/AnzctrAttachments/375108-MX-M464N_20161114_110304.pdf (Supplementary information)
Attachments [13] 2703 2703 0 0
/AnzctrAttachments/375108-Approval for DLQI and CDLQI use.pdf (Other)
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
/AnzctrAttachments/375108-wet wrap garment photo.docx (Other)
Attachments [17] 2733 2733 0 0
/AnzctrAttachments/375108-Patient Feedback Questionnaire.docx (Other)

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
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
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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePilot study of a customized nanotextile wet garment treatment on moderate and severe atopic dermatitis: A randomized clinical trial.2020https://dx.doi.org/10.1111/pde.13981
N.B. These documents automatically identified may not have been verified by the study sponsor.