Bathing Additives in Pediatric Atopic Dermatitis
Bathing Additives in Management of Pediatric Atopic Dermatitis
1 other identifier
interventional
10
1 country
1
Brief Summary
The current clinical guidelines for management of atopic dermatitis now recommend bleach baths. This requires simply the addition of regular household bleach to twice-weekly baths. At the Mayo Clinic, dilute acetic acid (vinegar) has been recommended for decades in wet wraps to treat patients hospitalized for their atopic dermatitis. However, this practice has not been widely adopted in the pediatric dermatology community. Will the use of dilute acetic acid (vinegar) in twice weekly baths help manage atopic dermatitis in pediatric patients as well as, or better than, the current accepted guidelines?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedFirst Posted
Study publicly available on registry
October 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedAugust 31, 2018
August 1, 2018
2.5 years
September 21, 2015
August 28, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
EASI score at 6 months
6 months
Secondary Outcomes (1)
Courses of antibiotics required
1 year
Study Arms (2)
Bleach
ACTIVE COMPARATORPatients will use bleach added to their baths twice a week.
Vinegar
ACTIVE COMPARATORPatients will use vinegar (dilute acetic acid) added to their baths twice a week.
Interventions
Eligibility Criteria
You may qualify if:
- Patients from 6 months to 17 years of age
- Currently residing in US.
- Follow up visits at 1 month, 3 months and 6 months after initiation of treatment in study (Figure 1).
- Last follow-up at 1 year in clinic or via written mailed-out survey.
- Diagnosis of atopic dermatitis AND
- Have active signs of bacterial skin infection OR
- Any documented suspected history of bacterial skin infection (weeping, crusting, and/or pustules on exam), OR
- Prescription for oral antibiotics for skin infection in the past 6 months from any provider). OR
- Have been prescribed bleach baths as part of an atopic dermatitis skin care regimen.
You may not qualify if:
- Superficial skin infection without diagnosis of atopic dermatitis
- Lack of in-clinic follow up assessment at 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Megha Tollefson, MD
Mayo Clinic
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
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant
Study Record Dates
First Submitted
September 21, 2015
First Posted
October 21, 2015
Study Start
October 1, 2015
Primary Completion
April 1, 2018
Study Completion
April 1, 2018
Last Updated
August 31, 2018
Record last verified: 2018-08