The Role of Bathing Additives in the Treatment of Pediatric Atopic Dermatitis

NCT03775590 | Terminated

• 1 other identifier: 18-006224
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Atopic Dermatitis; Eczema

Keywords

Atopic Dermatitis; Eczema

Outcome Measures

Primary Outcomes (1)

• Eczema Area and Severity Index (EASI) score improvement from baseline

  The EASI score is a validated composite score that ranges from 0 (clear) to 72 (very severe). The EASI is assessed and calculated as: the proportion of affected body surface area (BSA) was estimated from 4 designated body regions (head/neck, upper limbs, trunk, and lower limbs), and the Physician's Assessment of Individual Signs was determined for each region. The Physician's Assessment of Individual Signs grades signs of AD (erythema, edema/induration/papulation, excoriation, oozing/weeping/crusting, scaling, and lichenification) on a 4-point scale, ranging from absent to severe. Both the proportion of affected BSA and the Physician's Assessment of Individual Signs score are used to calculate the EASI score.

  At each visit until the last visit at 6 months

Secondary Outcomes (8)

• Patient Oriented Eczema Measure (POEM)

  At each visit until the last visit at 6 months

• Infant Dermatitis Quality of Life (IDQOL) for children under 4 years old

  At each visit until the last visit at 6 months

• Children's Dermatitis Quality of Life Index (CDQLI) for children at 4 years old or greater

  At each visit until the last visit at 6 months

• Rate of oral antibiotic prescribing

  At each visit until the last visit at 6 months

• Presence of staphylococcus aureus on involved skin

  At each visit until the last visit at 6 months

Study Arms (3)

Water

ACTIVE COMPARATOR

Subjects will bathe at least twice a week in a water bath for 6 months and keep a record of their bathing regimen

Procedure: Water

Bleach

ACTIVE COMPARATOR

Subjects will bathe at least twice a week in a water + dilute bleach bath for 6 months and keep a record of their bathing regimen

Procedure: Bleach

Acetic acid

ACTIVE COMPARATOR

Subjects will bathe at least twice a week in a water bath + vinegar for 6 months and keep a record of their bathing regimen

Procedure: Acetic acid

Interventions

Water PROCEDURE

To evaluate using water in the treatment of atopic dermatitis

Water

Bleach PROCEDURE

To evaluate using water + dilute bleach in the treatment of atopic dermatitis

Bleach

Acetic acid PROCEDURE

To evaluate using water + vinegar in the treatment of atopic dermatitis

Also known as: vinegar

Acetic acid

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• HealthPartners Institute: collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

HealthPartners

Saint Paul, Minnesota, 55130, United States

Location

Related Publications (5)

• 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.

  PMID: 24813302 BACKGROUND

• 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.

  PMID: 19403473 BACKGROUND

• 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.

  PMID: 26270469 BACKGROUND

• 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.

  PMID: 27543211 BACKGROUND

• 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.

  PMID: 24290431 BACKGROUND

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

Water; Acetic Acid

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Megha M Tollefson, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Sarah Asch, MD

  HealthPartners Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: There are 3 study arms with 50 subjects in each arm. The 3 arms are: water, water + bleach, and water + vinegar

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: December 14, 2018
• Study Start: February 21, 2019
• Primary Completion: September 15, 2019
• Study Completion: September 15, 2019
• Last Updated: May 12, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)