Chapel Hill, North Carolina 27516


Purpose:

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 summary:

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?


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.


Study is Available At:


Original ID:

18-1227


NCT ID:

NCT03619161


Secondary ID:


Study Acronym:


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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

6 Months


Maximum Age:

17 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of North Carolina, Chapel Hill


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

60


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Craig N Burkhart, MD
Principal Investigator
University of North Carolina, Chapel Hill
Primary Contact:Craig N Burkhart, MD
9849743900
Burkhart@med.unc.edu

Study Dates

Start Date:June 21, 2018
Completion Date:August 2019
Completion Type:Anticipated
Primary Completion Date:August 2019
Primary Completion Type:Anticipated
Verification Date:April 2019
Last Changed Date:April 22, 2019
First Received Date:July 27, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Absolute change in POEM score From Baseline (day 0) to Week 4 (day 28)
Time Frame:Baseline (day 0) to Week 4 (day 28)
Safety Issues:False
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

Study Interventions

Intervention Type:Other
Name:Bubbles
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)
Arm Name:Bubbles
Other Name:cleaning
Intervention Type:Other
Name:Bleach and Bubbles
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).
Arm Name:Bleach and Bubbles
Other Name:cleaning

Study Arms

Study Arm Type:Active Comparator
Arm Name:Bleach and Bubbles
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.
Study Arm Type:Experimental
Arm Name:Bubbles
Description:Patients will have a bacterial culture taken from their bathtub and have their bathrooms cleaned by the investigators
Study Arm Type:No Intervention
Arm Name:No cleaning (control)
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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of North Carolina, Chapel Hill

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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