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Study closed due to lack of enrollment.
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| Name | Class |
|---|---|
| HealthPartners Institute | OTHER |
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To evaluate the efficacy of water bath, water + bleach, and water + vinegar (acetic acid) in the treatment of atopic dermatitis (eczema)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Water | Procedure | To evaluate using water in the treatment of atopic dermatitis |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| At each visit until the last visit at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Megha M Tollefson, MD | Mayo Clinic | Principal Investigator |
| Sarah Asch, MD | HealthPartners Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States | ||
| HealthPartners |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24813302 | Background | 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. | |
| 19403473 |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D014867 | Water |
| D019342 | Acetic Acid |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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There are 3 study arms with 50 subjects in each arm. The 3 arms are: water, water + bleach, and water + vinegar
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| Bleach |
| Procedure |
To evaluate using water + dilute bleach in the treatment of atopic dermatitis |
|
| Acetic acid | Procedure | To evaluate using water + vinegar in the treatment of atopic dermatitis |
|
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Saint Paul |
| Minnesota |
| 55130 |
| United States |
| 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. |
| 26270469 | 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. |
| 27543211 | 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. |
| 24290431 | 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. |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |