The Role of Bathing Additives in the Treatment of Pediatric Atopic Dermatitis
- Conditions
- EczemaAtopic Dermatitis
- Interventions
- Procedure: WaterProcedure: BleachProcedure: Acetic acid
- Registration Number
- NCT03775590
- Lead Sponsor
- Mayo Clinic
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Water Water Subjects will bathe at least twice a week in a water bath for 6 months and keep a record of their bathing regimen Bleach Bleach 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 Acetic acid Subjects will bathe at least twice a week in a water bath + vinegar for 6 months and keep a record of their bathing regimen
- Primary Outcome Measures
Name Time Method Eczema Area and Severity Index (EASI) score improvement from baseline At each visit until the last visit at 6 months 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.
- Secondary Outcome Measures
Name Time Method 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 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.
Changes in Investigator's Global Assessment (IGA) score from baseline At each visit until the last visit at 6 months The IGA score (clear, almost clear, mild, moderate, severe, very severe; on numbered scaled where 0 = clear and 5 = very severe) at each visit
Patient Oriented Eczema Measure (POEM) At each visit until the last visit at 6 months 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 eczemaPresence of staphylococcus aureus on involved skin At each visit until the last visit at 6 months Differences in S. aureus colonization rates between each study arm at 2-4 months and at 6 months.
Rate of oral antibiotic prescribing At each visit until the last visit at 6 months The number of oral courses of antibiotics given for skin related concerns at 2-4 months and at 6 months in each group.
Infant Dermatitis Quality of Life (IDQOL) for children under 4 years old At each visit until the last visit at 6 months 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.
Frequency and severity of atopic dermatitis flares At each visit until the last visit at 6 months Number and severity of flares in each group within 2-4 months and within 6 months
pH of the skin At each visit until the last visit at 6 months Differences between the pH of the skin between the three study arms at 2-4 months and at 6 months
Trial Locations
- Locations (2)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
HealthPartners
🇺🇸Saint Paul, Minnesota, United States