Atopic Dermatitis
Conditions
Keywords
atopic dermatitis, bathing, baths
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALInfrequent versus Frequent Soaking Baths
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.
Sponsors
MaineHealth
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
A single treating physician assessed outcomes and, along with those analyzing the data, was masked to group assignment. In other words, the care provider, investigator, and outcomes assessor were blinded to which bathing arm (twice daily or twice weekly) the study participants were in.
Intervention model description
Randomized, Single-blinded, Prospective Crossover Controlled Trial
Eligibility
Sex/Gender
ALL
Age
6 Months to 11 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SCORAD (SCORing Atopic Dermatitis eczema severity score) | 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
| Measure | Time frame | Description |
|---|---|---|
| IDQOL (Infant Dermatitis Quality of life index for under 4 years of age) | 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. |
| CDLQI (Children's Dermatology Life Quality Index for 4 years of age and older) | 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. |
| DFI (Dermatitis Family Impact questionnaire for QOL measure for 5 and up) | 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. |
| ADQ (Atopic Dermatitis Quickscore eczema severity score) | 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. |
| Skin hydration status | 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. |
| Amount of topical corticosteroid (Desonide 0.05% Oint.) used | 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 |
| Amount of topical moisturizer (Vanicream) used | 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 |
| Staphylococcal aureus (S. aureus); relative quantities | 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. |
Countries
United States
Outcome results
None listed