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

Summary

Participation Requirements

Description

Atopic dermatitis (eczema) is a chronically recurrent, pruritic disorder most common in infants and young children. It is one of the most common pediatric dermatologic disorders, affecting 15-20% of all children between 6 months and 10 years of age. The vast majority of affected children (up to 85%)...

Atopic dermatitis (eczema) is a chronically recurrent, pruritic disorder most common in infants and young children. It is one of the most common pediatric dermatologic disorders, affecting 15-20% of all children between 6 months and 10 years of age. The vast majority of affected children (up to 85%) have the first outbreak during infancy. The distribution of lesions is characteristically symmetric, involving the face and extensor surfaces during infancy and the flexural surfaces in later childhood. Afflicted children experience pruritic erythematous vesicles, papules, and plaques that weep and crust. Studies have found that up to 34% of children with atopic dermatitis report a "large or extremely large" effect on quality of life, and over 60% report experiencing sleeplessness due to itching and soreness. Other common frustrations include miserable mood changes, difficulties with dressing and bathing, and social isolation. Traditionally, eczema guidelines have recommended loose cotton clothing and avoidance of rough fabrics such as wool which may cause irritation. Tencel is a botanic fiber derived from raw wood and has been marketed as a superior fabric for children with eczema. Industry studies of Tencel reported a 50% increase in moisture absorption compared to cotton and up to 2000 times less bacterial growth compared to polyamide (Tencel also had less bacterial growth than cotton or polyester). However, to date, no dermatologic studies have been conducted on the use of Tencel clothing to treat children with eczema. Because the investigators' department has observed several children achieve impressive reductions in eczema severity while using Tencel clothing, the investigators seek to conduct a formal study of this new textile. A double blind randomized trial of 3 months 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 randomized (1:1) to be treated with Tencel vs. cotton therapeutic garments in addition to standard eczema care. Randomization will be computer-generated and parents will be blinded to whether the children receive Tencel vs. cotton garments. Children will be stratified into age greater or less than 3 years. Children age 6 months to 3 years will wear either a Tencel or cotton full body suit with feet and mittens, while children age 3-6 years will wear Tencel or cotton long-sleeve shirts and pants that do not cover the hands and feet. Children will wear the study garments at night but may also wear garments during the day if desired (parent will estimate percentage of daytime hours that child wears garment). Parents will receive calendars and stickers to record nights that children wear the study garments, with a goal of wearing the study garments greater than 50% of the time. Blinded dermatology residents and fellows will assess EASI scores and Investigator's Global Assessment scores for each child at study initiation, 1 month, 2 months, and 3 months. CDQLI or IDQoL and ItchyQoL will also be assessed at each clinic visit. While some clinical photographs may be taken according to parental consent, no photographs will be taken of the genital area.

Tracking Information