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

Primary Purpose

Eczema, Atopic Dermatitis, Atopic Dermatitis and Related Conditions

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bubbles
Bleach and Bubbles
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eczema focused on measuring atopic dermatitis, eczema, bleach bath, bacteria, bathroom, cleaning

Eligibility Criteria

6 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Active Comparator

Arm Label

No cleaning (control)

Bubbles

Bleach and Bubbles

Arm Description

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.

Patients will have a bacterial culture taken from their bathtub and have their bathrooms cleaned by the investigators

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.

Outcomes

Primary Outcome Measures

Absolute change in POEM score From 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).

Secondary Outcome Measures

Full Information

First Posted
July 27, 2018
Last Updated
May 10, 2021
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT03619161
Brief Title
Bleach vs. Bubbles: Assessing the Impact of the Bathroom Environment on Eczema
Official Title
Bleach vs. Bubbles: Assessing the Impact of the Bathroom Environment on Eczema
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 21, 2018 (Actual)
Primary Completion Date
December 18, 2019 (Actual)
Study Completion Date
December 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
Detailed Description
The study will evaluate the effect of two interventions. 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). 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. When the intervention period ends at 4 weeks, the placebo arm will be offered a bathroom cleaning. There will be four quantitative assessment phases: 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). 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. The investigators will obtain a POEM score over the phone 1 week after obtaining the cultures. 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: 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. Work difficulty: Description of activities performed and any physical, mental, and emotional toil related to the labor with suggestions for improving the work experience. 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eczema, Atopic Dermatitis, Atopic Dermatitis and Related Conditions
Keywords
atopic dermatitis, eczema, bleach bath, bacteria, bathroom, cleaning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No cleaning (control)
Arm Type
No Intervention
Arm Description
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.
Arm Title
Bubbles
Arm Type
Experimental
Arm Description
Patients will have a bacterial culture taken from their bathtub and have their bathrooms cleaned by the investigators
Arm Title
Bleach and Bubbles
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Bubbles
Other Intervention Name(s)
cleaning
Intervention Description
All bathrooms with showers or bathtubs will be cleansed with simple products (dilute bleach, dilute white vinegar, baking soda, and dilute Dawn dish soap)
Intervention Type
Other
Intervention Name(s)
Bleach and Bubbles
Other Intervention Name(s)
cleaning, bleach bath
Intervention Description
All bathrooms with showers or bathtubs will be cleansed with simple products (dilute bleach, dilute white vinegar, baking soda, and dilute Dawn dish soap).
Primary Outcome Measure Information:
Title
Absolute change in POEM score From Baseline (day 0) to Week 4 (day 28)
Description
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).
Time Frame
Baseline (day 0) to Week 4 (day 28)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig N Burkhart, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27516
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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

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