Back to results

Bathing Additives in Pediatric Atopic Dermatitis

Primary Purpose

Dermatitis, Atopic

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Bathing Additive

About this trial

This is an interventional treatment trial for Dermatitis, Atopic

Eligibility Criteria

6 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

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
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:

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

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Bleach

Vinegar

Arm Description

Patients will use bleach added to their baths twice a week.

Patients will use vinegar (dilute acetic acid) added to their baths twice a week.

Outcomes

Primary Outcome Measures

EASI score at 6 months

Secondary Outcome Measures

Courses of antibiotics required

Full Information

NCT ID

NCT02582788

First Posted

September 21, 2015

Last Updated

August 28, 2018

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT02582788

Brief Title

Bathing Additives in Pediatric Atopic Dermatitis

Official Title

Bathing Additives in Management of Pediatric Atopic Dermatitis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Terminated

Study Start Date

October 2015 (undefined)

Primary Completion Date

April 2018 (Actual)

Study Completion Date

April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Data Monitoring Committee

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dermatitis, Atopic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bleach

Arm Type

Active Comparator

Arm Description

Patients will use bleach added to their baths twice a week.

Arm Title

Vinegar

Arm Type

Active Comparator

Arm Description

Patients will use vinegar (dilute acetic acid) added to their baths twice a week.

Intervention Type

Other

Intervention Name(s)

Bathing Additive

Primary Outcome Measure Information:

Title

EASI score at 6 months

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Courses of antibiotics required

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Megha Tollefson, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Bathing Additives in Pediatric Atopic Dermatitis

We'll reach out to this number within 24 hrs