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

NCT03619161 | Completed

• 1 other identifier: 18-1227
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Conditions

Eczema; Atopic Dermatitis; Atopic Dermatitis and Related Conditions

Keywords

atopic dermatitis; eczema; bleach bath; bacteria; bathroom; cleaning

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline (day 0) to Week 4 (day 28)

Study Arms (3)

No cleaning (control)

NO INTERVENTION

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.

Bubbles

EXPERIMENTAL

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

Other: Bubbles

Bleach and Bubbles

ACTIVE COMPARATOR

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

Interventions

Bubbles OTHER

All bathrooms with showers or bathtubs will be cleansed with simple products (dilute bleach, dilute white vinegar, baking soda, and dilute Dawn dish soap)

Also known as: cleaning

Bubbles

Bleach and Bubbles OTHER

All bathrooms with showers or bathtubs will be cleansed with simple products (dilute bleach, dilute white vinegar, baking soda, and dilute Dawn dish soap).

Also known as: cleaning, bleach bath

Bleach and Bubbles

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27516, United States

Location

MeSH Terms

Conditions

Eczema; Dermatitis, Atopic

Interventions

Gastric Balloon

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Craig N Burkhart, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 7, 2018
• Study Start: June 21, 2018
• Primary Completion: December 18, 2019
• Study Completion: December 18, 2019
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be available beginning 9 to 36 months following publication provided the investigator meets the appropriate access criteria.
• 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.

Locations

US (1)