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

NCT03843437 | Withdrawn FDA Device

• 1 other identifier: IRB00176371
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis; Tencel fabric; cotton fabric

Outcome Measures

Primary Outcomes (2)

• Change in Atopic Dermatitis Severity score as assessed by Eczema Area and Severity Index (EASI) score

  Assessment of erythema, excoriation, swelling, and lichenification on four body sites, scores range from 0-71. 0=clear, 0.1-5.9=mild, 6.0-22.9=moderate, 23.0-72=severe. A 3 point change in EASI score will be considered clinically significant for this study.

  Baseline (At study initiation), 1 month, 2 months, and 3 months

• Change in Atopic Dermatitis Severity score as assessed by Investigator's Global Assessment for Atopic Dermatitis score

  Physicians decide which of the following five categories best fits the patient: 0 = clear: "No inflammatory signs of atopic dermatitis (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Post-inflammatory hyperpigmentation or hypopigmentation may be present." 1. = almost clear: "Barely perceptible erythema, barely perceptible induration/papulation, and/or minimal lichenification. No oozing or crusting." 2. = mild: "Slight but definite erythema (pink), slight but definite induration/papulation, and/or slight but definite lichenification. No oozing or crusting." 3. = moderate: "Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification. Oozing and crusting may be present." 4. = severe: "Marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification. Disease is widespread in extent. Oozing or crusting may be present."

  Baseline (At study initiation), 1 month, 2 months, and 3 months

Secondary Outcomes (4)

• Change in patient-reported pruritus as assessed by ItchyQoL

  Baseline (At study initiation), 1 month, 2 months, and 3 months

• Change in patient-reported quality of life as assessed by Children's Dermatology Life Quality Index (CDQLI)

  Baseline (At study initiation), 1 month, 2 months, and 3 months

• Change in patient-reported quality of life as assessed by Infant's Dermatitis Quality of Life Index (IDQoL)

  Baseline (At study initiation), 1 month, 2 months, and 3 months

• Incidence of superinfection of Atopic Dermatitis Lesions

  12 weeks

Study Arms (2)

Tencel Therapeutic Garments

EXPERIMENTAL

Children in this group will wear Tencel Therapeutic Garments

Device: Tencel Therapeutic Garments

Cotton Therapeutic Garments

PLACEBO COMPARATOR

Children in this group will wear Cotton Therapeutic Garments

Device: Cotton Therapeutic Garments

Interventions

Tencel Therapeutic Garments DEVICE

Children age 6 months to 3 years will wear a Tencel full body suit with feet and mittens, while children age 3-6 years will wear Tencel 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.

Also known as: AD RescueWear "Rescue Suit"

Tencel Therapeutic Garments

Cotton Therapeutic Garments DEVICE

Children age 6 months to 3 years will wear a cotton full body suit with feet and mittens, while children age 3-6 years will wear 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.

Cotton Therapeutic Garments

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• AD RescueWear: collaborator

Study Sites (1)

Johns Hopkins Pediatric Dermatology Clinic

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Annie Grossberg, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: February 18, 2019
• Study Start: July 1, 2022
• Primary Completion: April 28, 2023
• Study Completion: June 28, 2024
• Last Updated: August 26, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)