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

Atopic Dermatitis Clinical Trial

— ASPIRE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03775590
• Other study ID #: 18-006224
• Status: Terminated
• Phase: N/A
• Start date: February 21, 2019
• Est. completion date: September 15, 2019

Study information

• Verified date: May 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 15, 2019
• Est. primary completion date: September 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Procedure:
• Water
To evaluate using water in the treatment of atopic dermatitis
• Bleach
To evaluate using water + dilute bleach in the treatment of atopic dermatitis
• Acetic acid
To evaluate using water + vinegar in the treatment of atopic dermatitis

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota
United States	HealthPartners	Saint Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	HealthPartners Institute

Country where clinical trial is conducted

United States, 

References & 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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient Oriented Eczema Measure (POEM)	The POEM measures the severity of eczema from a scale of 0-28 with 0 being clear and 28 as having severe eczema.; 0 to 2 = Clear or almost clear; 3 to 7 = Mild eczema; 8 to 16 = Moderate eczema; 17 to 24 = Severe eczema; 25 to 28 = Very severe eczema	At each visit until the last visit at 6 months
Secondary	Infant Dermatitis Quality of Life (IDQOL) for children under 4 years old	This quality of life (QoL) measures the patient quality of life from 0 - 30 with 0 being the patient's eczema doesn't have an affect on the patient's QoL while 30 means it has a profound effect on the patient's QoL.	At each visit until the last visit at 6 months
Secondary	Children's Dermatitis Quality of Life Index (CDQLI) for children at 4 years old or greater	This quality of life (QoL) measures the patient quality of life from 0 - 30 with 0 being the patient's eczema doesn't have an affect on the patient's QoL while 30 means it has a profound effect on the patient's QoL.	At each visit until the last visit at 6 months
Secondary	Rate of oral antibiotic prescribing	The number of oral courses of antibiotics given for skin related concerns at 2-4 months and at 6 months in each group.	At each visit until the last visit at 6 months
Secondary	Presence of staphylococcus aureus on involved skin	Differences in S. aureus colonization rates between each study arm at 2-4 months and at 6 months.	At each visit until the last visit at 6 months
Secondary	Changes in Investigator's Global Assessment (IGA) score from baseline	The IGA score (clear, almost clear, mild, moderate, severe, very severe; on numbered scaled where 0 = clear and 5 = very severe) at each visit	At each visit until the last visit at 6 months
Secondary	Frequency and severity of atopic dermatitis flares	Number and severity of flares in each group within 2-4 months and within 6 months	At each visit until the last visit at 6 months
Secondary	pH of the skin	Differences between the pH of the skin between the three study arms at 2-4 months and at 6 months	At each visit until the last visit at 6 months

External Links

•   Mayo Clinic Clinical Trials