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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02582788
Other study ID # 15-003161
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 2015
Est. completion date April 2018

Study information

Verified date August 2018
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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?


Recruitment information / eligibility

Status Terminated
Enrollment 10
Est. completion date April 2018
Est. primary completion date April 2018
Accepts healthy volunteers No
Gender All
Age group 6 Months to 17 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Bathing Additive


Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary EASI score at 6 months 6 months
Secondary Courses of antibiotics required 1 year
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