Bathing Additives in Management of Pediatric Atopic Dermatitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Mayo Clinic
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- EASI score at 6 months
Study Overview
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?
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 6 Months to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Superficial skin infection without diagnosis of atopic dermatitis
- •Lack of in-clinic follow up assessment at 6 months
Arms & Interventions
Bleach
Patients will use bleach added to their baths twice a week.
Intervention: Bathing Additive (Other)
Vinegar
Patients will use vinegar (dilute acetic acid) added to their baths twice a week.
Intervention: Bathing Additive (Other)
Outcomes
Primary Outcomes
EASI score at 6 months
Time Frame: 6 months
Secondary Outcomes
- Courses of antibiotics required(1 year)
Investigators
Megha M. Tollefson, M.D.
Consultant
Mayo Clinic