<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03775590</url>
  </required_header>
  <id_info>
    <org_study_id>18-006224</org_study_id>
    <nct_id>NCT03775590</nct_id>
  </id_info>
  <brief_title>The Role of Bathing Additives in the Treatment of Pediatric Atopic Dermatitis</brief_title>
  <acronym>ASPIRE</acronym>
  <official_title>The Role of Bathing Additives in the Treatment of Pediatric Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>HealthPartners Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the efficacy of water bath, water + bleach, and water + vinegar (acetic acid) in&#xD;
      the treatment of atopic dermatitis (eczema)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To perform a randomized controlled study to evaluate the efficacy of adding dilute acetic&#xD;
      acid to the bath twice weekly on the Eczema Area and Severity Index (EASI) score as compared&#xD;
      to adding dilute bleach to the bath including a control arm in which no solution is added to&#xD;
      the bath.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study closed due to lack of enrollment.&#xD;
  </why_stopped>
  <start_date type="Actual">February 21, 2019</start_date>
  <completion_date type="Actual">September 15, 2019</completion_date>
  <primary_completion_date type="Actual">September 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>There are 3 study arms with 50 subjects in each arm. The 3 arms are: water, water + bleach, and water + vinegar</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Eczema Area and Severity Index (EASI) score improvement from baseline</measure>
    <time_frame>At each visit until the last visit at 6 months</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Oriented Eczema Measure (POEM)</measure>
    <time_frame>At each visit until the last visit at 6 months</time_frame>
    <description>The POEM measures the severity of eczema from a scale of 0-28 with 0 being clear and 28 as having severe eczema.&#xD;
0 to 2 = Clear or almost clear&#xD;
3 to 7 = Mild eczema&#xD;
8 to 16 = Moderate eczema&#xD;
17 to 24 = Severe eczema&#xD;
25 to 28 = Very severe eczema</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant Dermatitis Quality of Life (IDQOL) for children under 4 years old</measure>
    <time_frame>At each visit until the last visit at 6 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Children's Dermatitis Quality of Life Index (CDQLI) for children at 4 years old or greater</measure>
    <time_frame>At each visit until the last visit at 6 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of oral antibiotic prescribing</measure>
    <time_frame>At each visit until the last visit at 6 months</time_frame>
    <description>The number of oral courses of antibiotics given for skin related concerns at 2-4 months and at 6 months in each group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of staphylococcus aureus on involved skin</measure>
    <time_frame>At each visit until the last visit at 6 months</time_frame>
    <description>Differences in S. aureus colonization rates between each study arm at 2-4 months and at 6 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Investigator's Global Assessment (IGA) score from baseline</measure>
    <time_frame>At each visit until the last visit at 6 months</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency and severity of atopic dermatitis flares</measure>
    <time_frame>At each visit until the last visit at 6 months</time_frame>
    <description>Number and severity of flares in each group within 2-4 months and within 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pH of the skin</measure>
    <time_frame>At each visit until the last visit at 6 months</time_frame>
    <description>Differences between the pH of the skin between the three study arms at 2-4 months and at 6 months</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Atopic Dermatitis</condition>
  <condition>Eczema</condition>
  <arm_group>
    <arm_group_label>Water</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will bathe at least twice a week in a water bath for 6 months and keep a record of their bathing regimen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bleach</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acetic acid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Water</intervention_name>
    <description>To evaluate using water in the treatment of atopic dermatitis</description>
    <arm_group_label>Water</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bleach</intervention_name>
    <description>To evaluate using water + dilute bleach in the treatment of atopic dermatitis</description>
    <arm_group_label>Bleach</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Acetic acid</intervention_name>
    <description>To evaluate using water + vinegar in the treatment of atopic dermatitis</description>
    <arm_group_label>Acetic acid</arm_group_label>
    <other_name>vinegar</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Currently reside in the USA&#xD;
&#xD;
          -  Ability to comply with follow up visits at 2-4 months and at 6 months&#xD;
&#xD;
          -  Come to the last follow-up at 6 months in the clinic&#xD;
&#xD;
          -  At least 5% Body Surface Area (BSA) affected with AD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unclear diagnosis of atopic dermatitis&#xD;
&#xD;
          -  Inability to comply with additive baths&#xD;
&#xD;
          -  Inability to comply with follow-up visits&#xD;
&#xD;
          -  Lack of residence in the United States&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Megha M Tollefson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sarah Asch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>HealthPartners Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HealthPartners</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <reference>
    <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.</citation>
    <PMID>24813302</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>19403473</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>26270469</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>27543211</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24290431</PMID>
  </reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>November 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>May 10, 2021</last_update_submitted>
  <last_update_submitted_qc>May 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Megha M. Tollefson, M.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Atopic Dermatitis</keyword>
  <keyword>Eczema</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetic Acid</mesh_term>
    <mesh_term>Retinol acetate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03775590
org study id: 18-006224
nct id: NCT03775590
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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
primary purpose: Treatment
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Eczema Area and Severity Index (EASI) score improvement from baseline
time frame: At each visit until the last visit at 6 months
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.
measure: Patient Oriented Eczema Measure (POEM)
time frame: At each visit until the last visit at 6 months
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
measure: Infant Dermatitis Quality of Life (IDQOL) for children under 4 years old
time frame: At each visit until the last visit at 6 months
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.
measure: 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
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.
measure: Rate of oral antibiotic prescribing
time frame: At each visit until the last visit at 6 months
description: The number of oral courses of antibiotics given for skin related concerns at 2-4 months and at 6 months in each group.
measure: Presence of staphylococcus aureus on involved skin
time frame: At each visit until the last visit at 6 months
description: Differences in S. aureus colonization rates between each study arm at 2-4 months and at 6 months.
measure: Changes in Investigator's Global Assessment (IGA) score from baseline
time frame: At each visit until the last visit at 6 months
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
measure: Frequency and severity of atopic dermatitis flares
time frame: At each visit until the last visit at 6 months
description: Number and severity of flares in each group within 2-4 months and within 6 months
measure: pH of the skin
time frame: At each visit until the last visit at 6 months
description: Differences between the pH of the skin between the three study arms at 2-4 months and at 6 months
arm group label: Water
arm group type: Active Comparator
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 group label: Bleach
arm group type: Active Comparator
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 group label: Acetic acid
arm group type: Active Comparator
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: Water
description: To evaluate using water in the treatment of atopic dermatitis
arm group label: Water
intervention type: Procedure
intervention name: Bleach
description: To evaluate using water + dilute bleach in the treatment of atopic dermatitis
arm group label: Bleach
intervention type: Procedure
intervention name: Acetic acid
description: To evaluate using water + vinegar in the treatment of atopic dermatitis
arm group label: Acetic acid
other name: vinegar
criteria: 
gender: All
minimum age: 6 Months
maximum age: 17 Years
healthy volunteers: No
last name: Megha M Tollefson, MD
role: Principal Investigator
affiliation: Mayo Clinic
last name: Sarah Asch, MD
role: Principal Investigator
affiliation: HealthPartners Institute
facility: 
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
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.
PMID: 24813302
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.
PMID: 19403473
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.
PMID: 26270469
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.
PMID: 27543211
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.
PMID: 24290431
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Megha M. Tollefson, M.D.
investigator title: Principal Investigator
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
mesh term: Acetic Acid
mesh term: Retinol acetate
sharing ipd: No