An interventional study of Water and Bleach in Atopic Dermatitis and Eczema, sponsored by Mayo Clinic. Terminated at 2 sites in United States. Open to participants aged 6 Months to 17 Years. Per ClinicalTrials.gov, last updated 2021-05-12.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 5 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
To evaluate using water in the treatment of atopic dermatitis
To evaluate using water + dilute bleach in the treatment of atopic dermatitis
To evaluate using water + vinegar in the treatment of atopic dermatitis
Also known as: vinegar
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.
Time frame: At each visit until the last visit at 6 months
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At each visit until the last visit at 6 months
Plan to share: No
This study is terminated, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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