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

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

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

Conditions
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Atopic Dermatitis, Eczema

Intervention / Treatment
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* Procedure: Water
* Procedure: Bleach
* Procedure: Acetic acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There are 3 study arms with 50 subjects in each arm. The 3 arms are: water, water + bleach, and water + vinegar
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Water<br>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<br>* To evaluate using water in the treatment of atopic dermatitis<br>|
| Active Comparator: Bleach<br>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<br>* To evaluate using water + dilute bleach in the treatment of atopic dermatitis<br>|
| Active Comparator: Acetic acid<br>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<br>* To evaluate using water + vinegar in the treatment of atopic dermatitis<br>* Other names: vinegar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic Dermatitis, Eczema