Bleach vs. Bubbles: Assessing the Impact of the Bathroom Environment on Eczema

May 10, 2021 updated by: University of North Carolina, Chapel Hill

Purpose: Evaluate the impact of cleaning the bathroom environment on the severity of eczema. Determine if part of the efficacy of bleach baths may be in cleaning the bathroom. Record data on the process in order to improve future interventions.

Participants: Patients and families with eczema

Procedures (methods):

  • Obtain baseline eczema severity scores and bacterial cultures from bathtubs
  • Randomize subjects to receive (1) a bathtub culture alone; (2) a culture and bathroom cleaning; and (3) a culture, cleaning, and bleach baths.
  • Measure changes in eczema severity scores over 4 weeks
  • Qualitatively evaluate the process by participants and investigators

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will evaluate the effect of two interventions.

  1. At the start of the study, two-thirds of the patients (40 patients) will be randomized to have a culture taken from their bathtub with subsequent cleaning of all of their bathrooms (intervention arm) versus one-third (20 patients) only obtaining a culture taken from their bathtub with no cleaning (control arm).
  2. After cleansing the bathrooms in the intervention arm, this group will be randomized again so that half of this group (20 patients) receives instructions on performing twice weekly bleach baths and the other half (20 patients) does not.
  3. When the intervention period ends at 4 weeks, the placebo arm will be offered a bathroom cleaning.

There will be four quantitative assessment phases:

  1. Upon entry into the study the investigators will obtain basic demographic information (insurer, age, race/ethnicity), a history of skin infections and allergic diseases, an eczema severity score (POEM score), an eczema area and severity index score (EASI score), and record the participant's level of eczema therapy (weak-moderate topical steroids, strong topical steroids, or systemic immunomodulators).
  2. The investigators will obtain a culture from the bathtub used by every study subject. This will be prior to cleaning the bathroom if the participant is in the cleaning intervention arm.
  3. The investigators will obtain a POEM score over the phone 1 week after obtaining the cultures.
  4. After 4 weeks, the investigators will obtain a POEM score over the phone as well as document whether the participant received any antibiotics or had any visits to medical providers for atopy flares over the last 4 weeks. The investigators will also re-record the participant's level of eczema therapy (weak-moderate topical steroids, strong topical steroids, or systemic immunomodulators).

There will be one qualitative assessment:

Additionally, the study team will keep field notes documenting perceptions and experiences during the cleaning process. These qualitative documents will be used for process evaluation to improve home hygiene interventions and studies. Domains that the investigators will assess in field notes include:

  1. Environment: The general appearance of the exterior of the home and neighborhood, cleanliness and order within the home and bathrooms, the hospitality and dynamics of interacting with the family. The investigators will also take pictures of the bathroom before and after each cleansing.
  2. Work difficulty: Description of activities performed and any physical, mental, and emotional toil related to the labor with suggestions for improving the work experience.
  3. Assessment of usefulness to the family: Did the family find the intervention useful? Did the family mention ways to make the cleaning intervention better? If given bleach bath instructions, did the family appear receptive and willing to do bleach baths? Did it appear that the family would clean their bathroom regularly after the intervention?

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27516
        • The University of North Carolina at Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children with eczema who visit UNC pediatric dermatology during study enrollment (Summer 2018).
  • Currently on a class 1 topical steroid or systemic immunosuppressive agent to control his/her eczema at the time of recruitment.
  • A history of, or current clinical evaluation by the attending dermatologist showing, atopic dermatitis affecting at least 10% body surface area.

Exclusion Criteria:

  • Child or family member with a sensitivity to bleach.
  • Child has used bleach baths within the last 2 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No cleaning (control)
Patients will have a bacterial culture taken from their bathtub and then continue regular care. We will offer to clean their bathrooms after the 4 week intervention period ends.
Experimental: Bubbles
Patients will have a bacterial culture taken from their bathtub and have their bathrooms cleaned by the investigators
Other: Bubbles
All bathrooms with showers or bathtubs will be cleansed with simple products (dilute bleach, dilute white vinegar, baking soda, and dilute Dawn dish soap)
Other Names:
  • cleaning
Active Comparator: Bleach and Bubbles
Patients will have a bacterial culture taken from their bathtub, have their bathrooms cleaned by the investigators, and be given instructions to perform bleach baths twice weekly.
Other: Bleach and Bubbles
All bathrooms with showers or bathtubs will be cleansed with simple products (dilute bleach, dilute white vinegar, baking soda, and dilute Dawn dish soap).
Other Names:
  • cleaning
  • bleach bath

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute change in POEM score From Baseline (day 0) to Week 4 (day 28)
Time Frame: Baseline (day 0) to Week 4 (day 28)
POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease). A higher POEM score correlates with a poorer quality of life (QOL).
Baseline (day 0) to Week 4 (day 28)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Craig N Burkhart, MD, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2018

Primary Completion (Actual)

December 18, 2019

Study Completion (Actual)

December 18, 2019

Study Registration Dates

First Submitted

July 27, 2018

First Submitted That Met QC Criteria

August 2, 2018

First Posted (Actual)

August 7, 2018

Study Record Updates

Last Update Posted (Actual)

May 11, 2021

Last Update Submitted That Met QC Criteria

May 10, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-1227

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The investigators may share deidentified individual data that supports the results. This may include the study protocol, the statistical analysis plan, and/or the spreadsheet used to collect data.

IPD Sharing Time Frame

The data will be available beginning 9 to 36 months following publication provided the investigator meets the appropriate access criteria.

IPD Sharing Access Criteria

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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