Clinical trial NCT03775590: The Role of Bathing Additives in the Treatment of Pediatric Atopic Dermatitis
Official title: The Role of Bathing Additives in the Treatment of Pediatric Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atopic Dermatitis
Eczema
Keywords: Atopic Dermatitis
Eczema
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: HealthPartners Institute
First posted: 2018-12-14
Enrollment: 5
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are 3 study arms with 50 subjects in each arm. The 3 arms are: water, water + bleach, and water + vinegar
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of water bath, water + bleach, and water + vinegar (acetic acid) in the treatment of atopic dermatitis (eczema)

Detailed description: To perform a randomized controlled study to evaluate the efficacy of adding dilute acetic acid to the bath twice weekly on the Eczema Area and Severity Index (EASI) score as compared to adding dilute bleach to the bath including a control arm in which no solution is added to the bath.

Eligibility criteria: Inclusion Criteria:

* Currently reside in the USA
* Ability to comply with follow up visits at 2-4 months and at 6 months
* Come to the last follow-up at 6 months in the clinic
* At least 5% Body Surface Area (BSA) affected with AD

Exclusion Criteria:

* Unclear diagnosis of atopic dermatitis
* Inability to comply with additive baths
* Inability to comply with follow-up visits
* Lack of residence in the United States

Primary outcomes:
measure: Eczema Area and Severity Index (EASI) score improvement from baseline
timeFrame: At each visit until the last visit at 6 months
Secondary outcomes:
measure: Patient Oriented Eczema Measure (POEM)
timeFrame: At each visit until the last visit at 6 months
measure: Infant Dermatitis Quality of Life (IDQOL) for children under 4 years old
timeFrame: At each visit until the last visit at 6 months
measure: Children's Dermatitis Quality of Life Index (CDQLI) for children at 4 years old or greater
timeFrame: At each visit until the last visit at 6 months
measure: Rate of oral antibiotic prescribing
timeFrame: At each visit until the last visit at 6 months
measure: Presence of staphylococcus aureus on involved skin
timeFrame: At each visit until the last visit at 6 months
measure: Changes in Investigator's Global Assessment (IGA) score from baseline
timeFrame: At each visit until the last visit at 6 months
measure: Frequency and severity of atopic dermatitis flares
timeFrame: At each visit until the last visit at 6 months
measure: pH of the skin
timeFrame: At each visit until the last visit at 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Paul
country: United States
facility: HealthPartners
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Megha M Tollefson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HealthPartners Institute
name: Sarah Asch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eichenfield LF, Tom WL, Berger TG, Krol A, Paller AS, Schwarzenberger K, Bergman JN, Chamlin SL, Cohen DE, Cooper KD, Cordoro KM, Davis DM, Feldman SR, Hanifin JM, Margolis DJ, Silverman RA, Simpson EL, Williams HC, Elmets CA, Block J, Harrod CG, Smith Begolka W, Sidbury R. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014 Jul;71(1):116-32. doi: 10.1016/j.jaad.2014.03.023. Epub 2014 May 9.
citation: Huang JT, Abrams M, Tlougan B, Rademaker A, Paller AS. Treatment of Staphylococcus aureus colonization in atopic dermatitis decreases disease severity. Pediatrics. 2009 May;123(5):e808-14. doi: 10.1542/peds.2008-2217.
citation: Hon KL, Tsang YC, Lee VW, Pong NH, Ha G, Lee ST, Chow CM, Leung TF. Efficacy of sodium hypochlorite (bleach) baths to reduce Staphylococcus aureus colonization in childhood onset moderate-to-severe eczema: A randomized, placebo-controlled cross-over trial. J Dermatolog Treat. 2016;27(2):156-62. doi: 10.3109/09546634.2015.1067669. Epub 2015 Aug 13.
citation: Gonzalez ME, Schaffer JV, Orlow SJ, Gao Z, Li H, Alekseyenko AV, Blaser MJ. Cutaneous microbiome effects of fluticasone propionate cream and adjunctive bleach baths in childhood atopic dermatitis. J Am Acad Dermatol. 2016 Sep;75(3):481-493.e8. doi: 10.1016/j.jaad.2016.04.066.
citation: Eichenfield LF, Tom WL, Chamlin SL, Feldman SR, Hanifin JM, Simpson EL, Berger TG, Bergman JN, Cohen DE, Cooper KD, Cordoro KM, Davis DM, Krol A, Margolis DJ, Paller AS, Schwarzenberger K, Silverman RA, Williams HC, Elmets CA, Block J, Harrod CG, Smith Begolka W, Sidbury R. Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014 Feb;70(2):338-51. doi: 10.1016/j.jaad.2013.10.010. Epub 2013 Nov 27.