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

Primary Purpose

Atopic Dermatitis, Eczema

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Water
Bleach
Acetic acid
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis, Eczema

Eligibility Criteria

6 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic
  • HealthPartners

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Water

Bleach

Acetic acid

Arm Description

Subjects will bathe at least twice a week in a water bath for 6 months and keep a record of their bathing regimen

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

Subjects will bathe at least twice a week in a water bath + vinegar for 6 months and keep a record of their bathing regimen

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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.
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.
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.
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
Frequency and severity of atopic dermatitis flares
Number and severity of flares in each group within 2-4 months and within 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

Full Information

First Posted
November 6, 2018
Last Updated
May 10, 2021
Sponsor
Mayo Clinic
Collaborators
HealthPartners Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03775590
Brief Title
The Role of Bathing Additives in the Treatment of Pediatric Atopic Dermatitis
Acronym
ASPIRE
Official Title
The Role of Bathing Additives in the Treatment of Pediatric Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
Study closed due to lack of enrollment.
Study Start Date
February 21, 2019 (Actual)
Primary Completion Date
September 15, 2019 (Actual)
Study Completion Date
September 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
HealthPartners Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Eczema
Keywords
Atopic Dermatitis, Eczema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There are 3 study arms with 50 subjects in each arm. The 3 arms are: water, water + bleach, and water + vinegar
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Water
Arm Type
Active Comparator
Arm Description
Subjects will bathe at least twice a week in a water bath for 6 months and keep a record of their bathing regimen
Arm Title
Bleach
Arm Type
Active Comparator
Arm Description
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
Arm Title
Acetic acid
Arm Type
Active Comparator
Arm Description
Subjects will bathe at least twice a week in a water bath + vinegar for 6 months and keep a record of their bathing regimen
Intervention Type
Procedure
Intervention Name(s)
Water
Intervention Description
To evaluate using water in the treatment of atopic dermatitis
Intervention Type
Procedure
Intervention Name(s)
Bleach
Intervention Description
To evaluate using water + dilute bleach in the treatment of atopic dermatitis
Intervention Type
Procedure
Intervention Name(s)
Acetic acid
Other Intervention Name(s)
vinegar
Intervention Description
To evaluate using water + vinegar in the treatment of atopic dermatitis
Primary Outcome Measure Information:
Title
Eczema Area and Severity Index (EASI) score improvement from baseline
Description
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
Secondary Outcome Measure Information:
Title
Patient Oriented Eczema Measure (POEM)
Description
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
Title
Infant Dermatitis Quality of Life (IDQOL) for children under 4 years old
Description
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
Title
Children's Dermatitis Quality of Life Index (CDQLI) for children at 4 years old or greater
Description
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
Title
Rate of oral antibiotic prescribing
Description
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
Title
Presence of staphylococcus aureus on involved skin
Description
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
Title
Changes in Investigator's Global Assessment (IGA) score from baseline
Description
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
Title
Frequency and severity of atopic dermatitis flares
Description
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
Title
pH of the skin
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megha M Tollefson, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sarah Asch, MD
Organizational Affiliation
HealthPartners Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
HealthPartners
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55130
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24813302
Citation
Eichenfield LF, Tom WL, Berger TG, Krol A, Paller AS, Schwarzenberger K, Bergman JN, Chamlin SL, Cohen DE, Cooper KD, Cordoro KM, Davis DM, Feldman SR, Hanifin JM, Margolis DJ, Silverman RA, Simpson EL, Williams HC, Elmets CA, Block J, Harrod CG, Smith Begolka W, Sidbury R. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014 Jul;71(1):116-32. doi: 10.1016/j.jaad.2014.03.023. Epub 2014 May 9.
Results Reference
background
PubMed Identifier
19403473
Citation
Huang JT, Abrams M, Tlougan B, Rademaker A, Paller AS. Treatment of Staphylococcus aureus colonization in atopic dermatitis decreases disease severity. Pediatrics. 2009 May;123(5):e808-14. doi: 10.1542/peds.2008-2217.
Results Reference
background
PubMed Identifier
26270469
Citation
Hon KL, Tsang YC, Lee VW, Pong NH, Ha G, Lee ST, Chow CM, Leung TF. Efficacy of sodium hypochlorite (bleach) baths to reduce Staphylococcus aureus colonization in childhood onset moderate-to-severe eczema: A randomized, placebo-controlled cross-over trial. J Dermatolog Treat. 2016;27(2):156-62. doi: 10.3109/09546634.2015.1067669. Epub 2015 Aug 13.
Results Reference
background
PubMed Identifier
27543211
Citation
Gonzalez ME, Schaffer JV, Orlow SJ, Gao Z, Li H, Alekseyenko AV, Blaser MJ. Cutaneous microbiome effects of fluticasone propionate cream and adjunctive bleach baths in childhood atopic dermatitis. J Am Acad Dermatol. 2016 Sep;75(3):481-493.e8. doi: 10.1016/j.jaad.2016.04.066.
Results Reference
background
PubMed Identifier
24290431
Citation
Eichenfield LF, Tom WL, Chamlin SL, Feldman SR, Hanifin JM, Simpson EL, Berger TG, Bergman JN, Cohen DE, Cooper KD, Cordoro KM, Davis DM, Krol A, Margolis DJ, Paller AS, Schwarzenberger K, Silverman RA, Williams HC, Elmets CA, Block J, Harrod CG, Smith Begolka W, Sidbury R. Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014 Feb;70(2):338-51. doi: 10.1016/j.jaad.2013.10.010. Epub 2013 Nov 27.
Results Reference
background
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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

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