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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 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03397979
Study type Interventional
Source Maine Medical Center
Contact
Status Completed
Phase N/A
Start date November 14, 2011
Completion date March 21, 2017
View Details
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