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



Status:Recruiting
Conditions:Psoriasis, Skin and Soft Tissue Infections, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:Any - 17
Updated:8/9/2018
Start Date:June 21, 2018
End Date:November 2018
Contact:Craig N Burkhart, MD
Email:Burkhart@med.unc.edu
Phone:9849743900

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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

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?

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.
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