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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03397979
• Other study ID #: 3927
• Status: Completed
• Phase: N/A
• First received: September 28, 2017
• Last updated: January 5, 2018
• Start date: November 14, 2011
• Est. completion date: March 21, 2017

Study information

• Verified date: January 2018
• Source: Maine Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 21, 2017
• Est. primary completion date: April 7, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Behavioral:
• Infrequent 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.

Locations

Country	Name	City	State
United States	Allergy and Asthma Associates of Maine	Portland	Maine

Sponsors (1)

Lead Sponsor	Collaborator
Maine Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SCORAD (SCORing Atopic Dermatitis eczema severity score)	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.	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.
Secondary	ADQ (Atopic Dermatitis Quickscore eczema severity score)	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.	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.
Secondary	IDQOL (Infant Dermatitis Quality of life index for under 4 years of age)	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.	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.
Secondary	CDLQI (Children's Dermatology Life Quality Index for 4 years of age and older)	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.	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.
Secondary	DFI (Dermatitis Family Impact questionnaire for QOL measure for 5 and up)	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.	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.
Secondary	Staphylococcal aureus (S. aureus); relative quantities	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.	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.
Secondary	Skin hydration status	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.	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.
Secondary	Amount of topical corticosteroid (Desonide 0.05% Oint.) used	Amount of Desonide 0.05% Oint. used based on weighing the desonide tube at each visit	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.
Secondary	Amount of topical moisturizer (Vanicream) used	Amount of Vanicream used based on weighing the Vanicream container at each visit	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.