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NCT Number: NCT03397979

Twice Daily Versus Twice Weekly Soak-and-Seal Baths in Pediatric Atopic Dermatitis

There are few studies evaluating best bathing practices in the management of pediatric atopic dermatitis (AD). Trans-epidermal water loss plays a key role in the pathophysiology of AD. In concert with application of topical corticosteroids (TCS), we sought to investigate whether frequent soaking baths (i.e. twice daily for two weeks), followed immediately by application of an occlusive moisturizer (i.e. soak-and-seal), would be more effective than infrequent soaking baths (i.e. twice weekly for two weeks) in the management of AD.

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Key information

Conditions

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

Age range

6 month–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Allergy and Asthma Associates of Maine

Portland, Maine, 04102, United States

About this study

To evaluate the effectiveness of twice daily soak-and-seal baths for improving severity of disease in children with AD, we implemented a randomized clinical trial using a single-blind, crossover-controlled design. Patients received the same moisturizer, cleanser, and class VI topical corticosteroid (TCS), and only bathing varied. After a 1 week run-in, children were randomized 1:1 into 2 groups: Group 1 underwent twice weekly soak-and-seal baths for 2 weeks ("dry method") followed by twice daily soak-and-seal baths for 2 weeks ("wet method"), and group 2 did the converse. A single treating physician assessed outcomes and, along with those analyzing the data, was masked to group assignment. Participants and their caregivers could not be masked. Analyses were based on intention to treat.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants and children ages 6 months to 11 years of age with moderate to severe atopic dermatitis according to the criteria of Hanifin and Rajka.

Exclusion criteria

  • Patients with suspected or established primary immune deficiency, patients receiving systemic corticosteroids, ultraviolet light therapy, immuno-therapeutic agents, and/or anti-infective drugs less than 1 month from the onset of the study.

Treatment and study plan

Infrequent versus Frequent Soaking Baths

Behavioral

Submersion of skin, affected by atopic dermatitis, in a bathtub filled with luke-warm water, where the frequency and duration of these baths are varied, to look for any differential effect.

Other names: Soak and seal baths, Soak and smear baths

Primary outcomes

  1. SCORAD (SCORing Atopic Dermatitis eczema severity score)

    Time frame: Each subject undergoes 4 visits over 5 weeks. Visit 1 (V1) to establish if subject fulfills inclusion criteria. V2 (baseline) is after a 1 week "run-in". 2 weeks between V2-V3 and V3-V4. Change in SCORAD from baseline (V2), for visits 3 minus visits 4.

    SCORAD (which stands for SCORing Atopic Dermatitis eczema severity score) is a validated eczema severity score assessed by the treating physician. The scale ranges from 0-103, with higher numbers correlating with more severe/worse eczema.

Secondary outcomes

  1. ADQ (Atopic Dermatitis Quickscore eczema severity score)

    Time frame: Each subject undergoes 4 visits over 5 weeks. Visit 1 (V1) to establish if subject fulfills inclusion criteria. V2 (baseline) is after a 1 week "run-in". 2 weeks between V2-V3 and V3-V4. Change in ADQ from baseline (V2), for visits 3 minus visits 4.

    ADQ (which stands for Atopic Dermatitis Quickscore) is a validated eczema severity score assessed by the caregivers of a child with AD. The scale ranges from 0-70, with higher numbers correlating with more severe/worse eczema.

  2. IDQOL (Infant Dermatitis Quality of life index for under 4 years of age)

    Time frame: Each subject undergoes 4 visits over 5 weeks. Visit 1 (V1) to establish if subject fulfills inclusion criteria. V2 (baseline) is after a 1 week "run-in". 2 weeks between V2-V3 and V3-V4. Change in IDQOL from baseline (V2), for visits 3 minus visits 4.

    IDQOL (Which stands for Infant Dermatitis Quality of life index) is a validated quality of life measuring tool for AD. The scale ranges from 0-44, with higher numbers correlating with more severe/worse eczema.

  3. CDLQI (Children's Dermatology Life Quality Index for 4 years of age and older)

    Time frame: Each subject undergoes 4 visits over 5 weeks. Visit 1 (V1) to establish if subject fulfills inclusion criteria. V2 (baseline) is after a 1 week "run-in". 2 weeks between V2-V3 and V3-V4. Change in CDLQI from baseline (V2), for visits 3 minus visits 4.

    CDLQI (Which stands for Children's Dermatology Life Quality Index) is a validated quality of life measuring tool for AD. The scale ranges from 0-40, with higher numbers correlating with more severe/worse eczema.

  4. DFI (Dermatitis Family Impact questionnaire for QOL measure for 5 and up)

    Time frame: Each subject undergoes 4 visits over 5 weeks. Visit 1 (V1) to establish if subject fulfills inclusion criteria. V2 (baseline) is after a 1 week "run-in". 2 weeks between V2-V3 and V3-V4. Change in DFI from baseline (V2), for visits 3 minus visits 4.

    DFI (which stands for Dermatitis Family Impact) is a validated quality of life measuring tool for AD. The scale ranges from 0-40, with higher numbers correlating with more severe/worse eczema.

  5. Staphylococcal aureus (S. aureus); relative quantities

    Time frame: Each subject undergoes 4 visits over 5 weeks. Visit 1 (V1) to establish if subject fulfills inclusion. V2 (baseline) is after a 1 week "run-in". 2 weeks between V2-V3 and V3-V4. Change in S. aureus from baseline (V2), for visits 3 minus visits visits 4.

    Relative quantities of S. aureus cultured from the skin. The scale ranges from 1+ rare, 2+ few, 3+ moderate, 4+ many, with higher numbers correlating with higher quantities of S. aureus on the skin.

  6. Skin hydration status

    Time frame: Each subject undergoes 4 visits over 5 weeks. Visit 1 (V1) to establish if subject fulfills inclusion. V2 (baseline) is after a 1 week "run-in". 2 weeks between V2-V3 and V3-V4. Change in skin hydration from baseline (V2), for visits 3 minus visits 4.

    Skin hydration status as measured by impedance-based capacitance utilizing the DPM 9003 instrument by Nova Tech. Corp. The scale ranges from 90-999, with higher values correlating with greater skin hydration.

  7. Amount of topical corticosteroid (Desonide 0.05% Oint.) used

    Time frame: Each subject undergoes 4 visits over 5 weeks. Visit 1 (V1) to establish if subject fulfills inclusion. V2 (baseline) is after a 1 week "run-in". 2 weeks between V2-V3 and V3-V4. Change in Desonide use from baseline (V2), for visits 3 minus visits 4.

    Amount of Desonide 0.05% Oint. used based on weighing the desonide tube at each visit

  8. Amount of topical moisturizer (Vanicream) used

    Time frame: Each subject undergoes 4 visits over 5 weeks. Visit 1 (V1) to establish if subject fulfills inclusion. V2 (baseline) is after a 1 week "run-in". 2 weeks between V2-V3 and V3-V4. Change in Vanicream use from baseline (V2), for visits 3 minus visits 4.

    Amount of Vanicream used based on weighing the Vanicream container at each visit

Sponsors and collaborators

Lead sponsor

MaineHealth

Other

Registry information

Official study title

Twice Daily Versus Twice Weekly Soak-and-Seal Baths in Pediatric Atopic Dermatitis: A Randomized, Single-blinded, Prospective Crossover Controlled Trial

Important dates

Study start
2011
Primary completion
2016
Study completion
2017
First posted
Jan 12, 2018
Registry last updated
Jan 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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