Bathing Additives in Pediatric Atopic Dermatitis

August 28, 2018 updated by: Megha M. Tollefson, M.D., Mayo Clinic

Bathing Additives in Management of Pediatric Atopic Dermatitis

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients from 6 months to 17 years of age
  2. Currently residing in US.
  3. Follow up visits at 1 month, 3 months and 6 months after initiation of treatment in study (Figure 1).
  4. Last follow-up at 1 year in clinic or via written mailed-out survey.

  5. Diagnosis of atopic dermatitis AND

    1. Have active signs of bacterial skin infection OR
    2. Any documented suspected history of bacterial skin infection (weeping, crusting, and/or pustules on exam), OR
    3. Prescription for oral antibiotics for skin infection in the past 6 months from any provider). OR
    4. Have been prescribed bleach baths as part of an atopic dermatitis skin care regimen.

Exclusion Criteria:

  1. Superficial skin infection without diagnosis of atopic dermatitis
  2. Lack of in-clinic follow up assessment at 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Bleach
Patients will use bleach added to their baths twice a week.
Other: Bathing Additive
ACTIVE_COMPARATOR: Vinegar
Patients will use vinegar (dilute acetic acid) added to their baths twice a week.
Other: Bathing Additive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
EASI score at 6 months
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Courses of antibiotics required
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Megha Tollefson, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ACTUAL)

April 1, 2018

Study Completion (ACTUAL)

April 1, 2018

Study Registration Dates

First Submitted

September 21, 2015

First Submitted That Met QC Criteria

October 19, 2015

First Posted (ESTIMATE)

October 21, 2015

Study Record Updates

Last Update Posted (ACTUAL)

August 31, 2018

Last Update Submitted That Met QC Criteria

August 28, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-003161

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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