The Role of Bathing Additives in the Treatment of Pediatric Atopic Dermatitis (ASPIRE)

Mayo Clinic

Status: Terminated

Conditions: Atopic Dermatitis; Eczema

Treatments: Procedure: Bleach; Procedure: Water; Procedure: Acetic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03775590

18-006224

Details and patient eligibility

About

To evaluate the efficacy of water bath, water + bleach, and water + vinegar (acetic acid) in the treatment of atopic dermatitis (eczema)

Full description

To perform a randomized controlled study to evaluate the efficacy of adding dilute acetic acid to the bath twice weekly on the Eczema Area and Severity Index (EASI) score as compared to adding dilute bleach to the bath including a control arm in which no solution is added to the bath.

Enrollment: 5 patients

Sex: All

Ages: 6 months to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Currently reside in the USA
• Ability to comply with follow up visits at 2-4 months and at 6 months
• Come to the last follow-up at 6 months in the clinic
• At least 5% Body Surface Area (BSA) affected with AD

Exclusion criteria

• Unclear diagnosis of atopic dermatitis
• Inability to comply with additive baths
• Inability to comply with follow-up visits
• Lack of residence in the United States

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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5 participants in 3 patient groups

Water

Active Comparator group

Description:

Subjects will bathe at least twice a week in a water bath for 6 months and keep a record of their bathing regimen

Treatment:

Procedure: Water

Bleach

Active Comparator group

Description:

Subjects will bathe at least twice a week in a water + dilute bleach bath for 6 months and keep a record of their bathing regimen

Treatment:

Procedure: Bleach

Acetic acid

Active Comparator group

Description:

Subjects will bathe at least twice a week in a water bath + vinegar for 6 months and keep a record of their bathing regimen

Treatment:

Procedure: Acetic acid