Tencel vs. Standard Cotton Therapeutic Garments as an Adjunct Treatment for Moderate to Severe Atopic Dermatitis in Children

Withdrawn before enrolling · Not applicable

Conditions studied: Atopic Dermatitis

In brief

Approximately 15-20% of children in the United States suffer from the symptoms of atopic dermatitis (eczema), which include pruritus, pain, irritation, and difficulty sleeping. Tencel fabric has been marketed as a superior fabric for children with atopic dermatitis due to improved moisture absorption and decreased bacterial growth compared to cotton and synthetic fabrics. However, no dermatologic studies have been conducted on Tencel fabric. The investigators' objective is to perform a randomized double-blinded trial comparing Tencel garments to traditional cotton for children with moderate to severe atopic dermatitis. The investigators hypothesize that children in the Tencel group will demonstrate improvement in Eczema Area and Severity Index (EASI) scores, Investigator's Global Assessment, pruritus as measured by ItchyQoL: A Pruritus-Specific Quality of Life Instrument, and Children's Dermatology Life Quality Index (CDQLI) or Infant's Dermatitis Quality of Life Index (IDQoL). An randomized double-blind trial of 12 weeks duration will be conducted. Fifty children age 6 months to 6 years with moderate to severe eczema will be recruited from the Johns Hopkins pediatric dermatology clinic and given 6 weeks of standard skin directed therapy followed by 6 weeks during which children will be randomized to treatment with Tencel vs. cotton therapeutic garments in addition to standard eczema care. The primary outcome will be eczema severity as assessed by EASI score by blinded and trained investigators. Secondary outcomes will include patient-reported eczema symptoms (assessed through quality of life and pruritus scales, CDQLI or IDQoL and ItchyQoL scores) and frequency of infection of eczema lesions. Adherence with wearing study garments and usage of standard eczema treatments (topical corticosteroids and calcineurin inhibitors, emollients, and wet/dry wraps) will also be assessed.

Key facts

Study ID

NCT03843437

Run by

Johns Hopkins University

People needed

0

Starts

2022-07-01

Expected to finish

2024-06-28

Last updated by the study team

2022-08-26

Who can join

Age: 1 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of moderate or severe atopic dermatitis based on Eczema Area and Severity Index (EASI) score (moderate=6-22.9; severe=23-72)
• At least one active patch of atopic dermatitis at time of study
• Parent/guardian able to give informed consent

You may not qualify if…

• Systemic medication or oral steroids within past 3 months (includes light therapy),
• Started new atopic dermatitis treatment regimen within the past month,
• Using wet/dry wraps > once/week

Where it is running

• Johns Hopkins Pediatric Dermatology Clinic — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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