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

MaineHealth

Status: Completed

Conditions: Atopic Dermatitis

Treatments: Behavioral: Infrequent versus Frequent Soaking Baths

Study type: Interventional

Funder types: Other

Identifiers

NCT03397979

3927

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 6 months to 11 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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63 participants in 2 patient groups

Infrequent soaking baths

Active Comparator group

Description:

Infrequent soaking baths, in this study, is defined as twice a week soaking baths for 10 minutes or less, over 2 weeks. However, this is a crossover study design with two interventions: 1) Infrequent soaking baths, as defined above, and 2) Frequent soaking baths (defined as twice daily soaking baths for 15-20 minutes, over 2 weeks). All subjects in the study will undergo both interventions, but in different order. Thus, this is a study comparing Infrequent Versus Frequent Soaking Baths. Each subject serves as their own control.

Treatment:

Behavioral: Infrequent versus Frequent Soaking Baths

Frequent soaking baths

Active Comparator group

Description:

Frequent soaking baths, in this study, is defined as twice daily soaking baths for 15-20 minutes, over 2 weeks. However, this is a crossover study design with two interventions: 1) Infrequent soaking baths, as defined in the first arm description above, and 2) Frequent soaking baths, as defined above in this arm description. All subjects in the study will undergo both interventions, but in different order. Thus, this is a study comparing Infrequent Versus Frequent Soaking Baths. Each subject serves as their own control.

Treatment:

Behavioral: Infrequent versus Frequent Soaking Baths