The Role of Bathing Additives in the Treatment of Pediatric Atopic Dermatitis

Mayo Clinic5 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Atopic Dermatitis Eczema

Interventions

WaterPROCEDURE

To evaluate using water in the treatment of atopic dermatitis

BleachPROCEDURE

To evaluate using water + dilute bleach in the treatment of atopic dermatitis

Acetic acidPROCEDURE

To evaluate using water + vinegar in the treatment of atopic dermatitis

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (2)

Mayo Clinic

Rochester, Minnesota, United States

HealthPartners

Saint Paul, Minnesota, United States

Outcomes

Primary Outcomes

Eczema Area and Severity Index (EASI) score improvement from baseline

The EASI score is a validated composite score that ranges from 0 (clear) to 72 (very severe). The EASI is assessed and calculated as: the proportion of affected body surface area (BSA) was estimated from 4 designated body regions (head/neck, upper limbs, trunk, and lower limbs), and the Physician's Assessment of Individual Signs was determined for each region. The Physician's Assessment of Individual Signs grades signs of AD (erythema, edema/induration/papulation, excoriation, oozing/weeping/crusting, scaling, and lichenification) on a 4-point scale, ranging from absent to severe. Both the proportion of affected BSA and the Physician's Assessment of Individual Signs score are used to calculate the EASI score.

Time frame: At each visit until the last visit at 6 months

Secondary Outcomes

Patient Oriented Eczema Measure (POEM)

The POEM measures the severity of eczema from a scale of 0-28 with 0 being clear and 28 as having severe eczema. * 0 to 2 = Clear or almost clear * 3 to 7 = Mild eczema * 8 to 16 = Moderate eczema * 17 to 24 = Severe eczema * 25 to 28 = Very severe eczema

Time frame: At each visit until the last visit at 6 months

Infant Dermatitis Quality of Life (IDQOL) for children under 4 years old

This quality of life (QoL) measures the patient quality of life from 0 - 30 with 0 being the patient's eczema doesn't have an affect on the patient's QoL while 30 means it has a profound effect on the patient's QoL.

Time frame: At each visit until the last visit at 6 months

Children's Dermatitis Quality of Life Index (CDQLI) for children at 4 years old or greater

Time frame: At each visit until the last visit at 6 months

Data from ClinicalTrials.gov

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