NCT03397979

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: MaineHealth · Academic / Other
• Sex: All
• Age: 6 Months – 11 Years
• Healthy volunteers: Accepted

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-11-14
• Primary completion: 2016-04-07
• Completion: 2017-03-21
• First posted: 2018-01-12
• Last updated: 2018-01-12

Locations

1 site across 1 country: United States