Clinical trial NCT03619161: 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
Overall status: COMPLETED
Phase: NA
Conditions: Eczema
Atopic Dermatitis
Atopic Dermatitis and Related Conditions
Keywords: atopic dermatitis
eczema
bleach bath
bacteria
bathroom
cleaning
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 58
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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?

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.

Primary outcomes:
measure: Absolute change in POEM score From Baseline (day 0) to Week 4 (day 28)
timeFrame: Baseline (day 0) to Week 4 (day 28)
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Craig N Burkhart, MD
role: PRINCIPAL_INVESTIGATOR
References: