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The Role of Bathing Additives in the Treatment of Pediatric Atopic Dermatitis (ASPIRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03775590
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
HealthPartners Institute
Information provided by (Responsible Party):
Megha M. Tollefson, M.D., 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)

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Eczema Procedure: Water Procedure: Bleach Procedure: Acetic acid Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Bathing Additives in the Treatment of Pediatric Atopic Dermatitis
Actual Study Start Date : February 21, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Active Comparator: Water
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
To evaluate using water in the treatment of atopic dermatitis

Active Comparator: 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
Procedure: Bleach
To evaluate using water + dilute bleach in the treatment of atopic dermatitis

Active Comparator: 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
Procedure: Acetic acid
To evaluate using water + vinegar in the treatment of atopic dermatitis
Other Name: vinegar




Primary Outcome Measures :
  1. Eczema Area and Severity Index (EASI) score improvement from baseline [ Time Frame: 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 :
  1. Patient Oriented Eczema Measure (POEM) [ Time Frame: 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

  2. Infant Dermatitis Quality of Life (IDQOL) for children under 4 years old [ Time Frame: 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.

  3. Children's Dermatitis Quality of Life Index (CDQLI) for children at 4 years old or greater [ Time Frame: 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.

  4. Rate of oral antibiotic prescribing [ Time Frame: 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.

  5. Presence of staphylococcus aureus on involved skin [ Time Frame: 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.

  6. Changes in Investigator's Global Assessment (IGA) score from baseline [ Time Frame: 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

  7. Frequency and severity of atopic dermatitis flares [ Time Frame: 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

  8. pH of the skin [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775590


Contacts
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Contact: Henry Nguyen, MD 507-284-4673 Nguyen.Henry@mayo.edu
Contact: Katrina Pierce 507-266-1078 Pierce.Katrina@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Henry Nguyen, MD    507-284-4673    Nguyen.Henry@mayo.edu   
Contact: Pierce Katrina    507-266-1078    Pierce.Katrina@mayo.edu   
Principal Investigator: Megha M Tollefson, MD         
HealthPartners Recruiting
Saint Paul, Minnesota, United States, 55130
Contact: Sarah S Asch, MD    651-254-7580    Sarah.S.Asch@HealthPartners.com   
Principal Investigator: Sarah S Asch, MD         
Sponsors and Collaborators
Mayo Clinic
HealthPartners Institute
Investigators
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Principal Investigator: Megha M Tollefson, MD Mayo Clinic
Principal Investigator: Sarah Asch, MD HealthPartners Institute

Additional Information:
Publications:

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Responsible Party: Megha M. Tollefson, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03775590    
Other Study ID Numbers: 18-006224
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Megha M. Tollefson, M.D., Mayo Clinic:
Atopic Dermatitis
Eczema
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Acetic Acid
Retinol acetate
Anti-Bacterial Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents