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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-21

Study Completion Date

2019-09-15

Brief Summary

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

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Detailed Description

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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.

Conditions

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Atopic Dermatitis Eczema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There are 3 study arms with 50 subjects in each arm. The 3 arms are: water, water + bleach, and water + vinegar

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Water

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

Group Type ACTIVE_COMPARATOR

Water

Intervention Type PROCEDURE

To evaluate using water in the treatment of atopic dermatitis

Bleach

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

Group Type ACTIVE_COMPARATOR

Bleach

Intervention Type PROCEDURE

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

Acetic acid

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

Group Type ACTIVE_COMPARATOR

Acetic acid

Intervention Type PROCEDURE

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

Interventions

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Water

To evaluate using water in the treatment of atopic dermatitis

Intervention Type PROCEDURE

Bleach

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

Intervention Type PROCEDURE

Acetic acid

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

Intervention Type PROCEDURE

Other Intervention Names

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vinegar

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No