Atopic Dermatitis, Eczema
Conditions
Keywords
Atopic Dermatitis, Eczema
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.
Interventions
PROCEDUREWater
To evaluate using water in the treatment of atopic dermatitis
PROCEDUREBleach
To evaluate using water + dilute bleach in the treatment of atopic dermatitis
PROCEDUREAcetic acid
To evaluate using water + vinegar in the treatment of atopic dermatitis
Sponsors
HealthPartners Institute
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Intervention model description
There are 3 study arms with 50 subjects in each arm. The 3 arms are: water, water + bleach, and water + vinegar
Eligibility
Sex/Gender
ALL
Age
6 Months to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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 eczema |
| 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 |
| 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 |
| Presence 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. |
Countries
United States
Outcome results
None listed