<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/NCT03042624</url>
  </required_header>
  <id_info>
    <org_study_id>FERCT16</org_study_id>
    <nct_id>NCT03042624</nct_id>
  </id_info>
  <brief_title>Efficacy of Fermented Rice Flour for the Treatment of Atopic Dermatitis: Randomized, Double-blind Controlled Trial</brief_title>
  <official_title>Efficacy of Fermented Rice Flour for the Treatment of Atopic Dermatitis: Randomized, Double-blind Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Milan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Milan</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>
      This trial aims at evaluating the efficacy of a fermented rice flour for the treatment of&#xD;
      atopic dermatitis (AD).&#xD;
&#xD;
      The fermented rice flour, obtained from Lactobacillus paracasei CBA L74 (Heinz Italia SpA,&#xD;
      Latina, Italy), does not contain live bacteria. Lactobacillus paracasei CBA L74 belongs to&#xD;
      the list of microorganisms with qualified presumption of safety compiled by the European Food&#xD;
      Safety Authority (EFSA), is tested for the absence of antibiotic resistance genes in&#xD;
      accordance with EFSA, and is genetically characterized by repetitive extragenic palindromic&#xD;
      polymerase chain reaction.&#xD;
&#xD;
      Using a repeated-measure cohort design, the investigators have recently shown that the&#xD;
      administration of a fermented-rice flour obtained from Lactobacillus paracasei CBA L74 was&#xD;
      associated with a decrease of the score for atopic dermatitis (SCORAD) in children with AD.&#xD;
&#xD;
      The present randomized, double-blind, controlled trial is aimed at testing whether the&#xD;
      fermented rice flour obtained from Lactobacillus paracasei CBA L74 is effective in reducing&#xD;
      SCORAD in children with moderate to severe AD using placebo as comparator.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Atopic dermatitis (AD), an itchy eczema with a chronic relapsing course, is the most common&#xD;
      clinical manifestation of atopy in the first years of life.&#xD;
&#xD;
      On the basis of the available knowledge, AD is produced by an alteration of the skin barrier&#xD;
      which triggers an inflammatory reaction. Such reaction is characterized by an early phase&#xD;
      with abundance of Th2 cytokines (IL-4, IL-5) and eosinophils and by a later phase with&#xD;
      predominance of Th1 cytokines (IL-2, IL-12 and IFN-gamma).&#xD;
&#xD;
      Emollients, possibly supplemented with ceramides, represent the first step of the treatment&#xD;
      of AD. Corticosteroids are the most effective topical drugs. The use of topical&#xD;
      immune-modulators (tacrolimus and pimecrolimus) offers an alternative to steroid therapy for&#xD;
      long-term treatments. Severe cases require systemic therapy with steroids and cyclosporine&#xD;
      and phototherapy with narrowband ultraviolet (UVB) and psoralen-ultraviolet A (PUVA)&#xD;
      phototherapy.&#xD;
&#xD;
      The use of probiotics for the treatment of AD has attracted much interest in recent years but&#xD;
      the available data are not conclusive. Probiotic-like effects can be obtained from&#xD;
      inactivated bacteria or isolated bacterial components so that an extensive definition of&#xD;
      probiotics has been proposed as bacterial cells or bacterial components that have a&#xD;
      beneficial impact on the health and well-being of guests.&#xD;
&#xD;
      Using a repeated-measure cohort design, the investigators have recently shown that the&#xD;
      administration of the fermented-rice flour obtained from Lactobacillus paracasei CBA L74 was&#xD;
      associated with a decrease of SCORAD (score for atopic dermatitis) in children with AD.&#xD;
&#xD;
      SCORAD is the most commonly employed indicator of AD activity and its minimal clinically&#xD;
      important difference is known, making it a suitable metric for clinical trials.&#xD;
&#xD;
      The fermented rice flour, obtained from Lactobacillus paracasei CBA L74 (Heinz Italia SpA,&#xD;
      Latina, Italy), does not contain live bacteria. Lactobacillus paracasei CBA L74 belongs to&#xD;
      the list of microorganisms with qualified presumption of safety compiled by the European Food&#xD;
      Safety Authority (EFSA), is tested for the absence of antibiotic resistance genes in&#xD;
      accordance with EFSA, and is genetically characterized by repetitive extragenic palindromic&#xD;
      polymerase chain reaction.&#xD;
&#xD;
      Pre-clinical studies have shown anti-inflammatory effects of matrices fermented with&#xD;
      Lactobacillus paracasei CBA-L74 in terms of production of IL-10 and reduction of IL-12 in&#xD;
      response to bacterial stimulation. Such pre-clinical data were obtained on dendritic cells,&#xD;
      on intestinal biopsies and on murine models.&#xD;
&#xD;
      The present randomized, double-blind, controlled trial is aimed at testing whether the&#xD;
      fermented rice flour obtained from Lactobacillus paracasei CBA L74 is effective in reducing&#xD;
      SCORAD in children with moderate to severe AD using placebo as comparator.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 24, 2017</start_date>
  <completion_date type="Anticipated">May 31, 2017</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2017</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>Parallel-arm, Randomized, Double-blind Controlled Trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>Each treatment is numbered consecutively without any reference to the underlying randomization scheme, which is known only to the statistician who generated the list and to the technician who prepared the packages. The packages and their contents are indistinguishable.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>SCORAD change</measure>
    <time_frame>12 weeks</time_frame>
    <description>The treatment will be stopped at 12 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SCORAD change</measure>
    <time_frame>16 weeks</time_frame>
    <description>The outcome will be evaluated also 4 weeks after the suspension of treatment</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Fecal microbiota composition</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Cytokine profiling</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measurement of peripheral IFN-gamma, IL-4, IL-5, IL-10, IL-12, IL-13, IL-18 and IL-31</description>
  </other_outcome>
  <other_outcome>
    <measure>Peripheral immunophenotyping</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measurement of peripheral Treg, central memory and effector and Th1/Th2/Th17 cells</description>
  </other_outcome>
  <other_outcome>
    <measure>Total and specific IgE</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Dermatitis, Atopic</condition>
  <condition>Child</condition>
  <condition>Infant</condition>
  <arm_group>
    <arm_group_label>Fermented rice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>7 g of fermented rice flour powder obtained from Lactobacillus paracasei CBA L74 to be diluted in milk or water</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Maltodextrins</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>7 g of maltodextrins powder to be diluted in milk or water</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Fermented rice</intervention_name>
    <description>7 g of powder obtained from Lactobacillus paracasei CBA L74</description>
    <arm_group_label>Fermented rice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Maltodextrins</intervention_name>
    <description>7 g of maltodextrins powder</description>
    <arm_group_label>Maltodextrins</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of moderate or sever atopic dermatitis using SCORAD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute rhino-conjunctivitis&#xD;
&#xD;
          -  acute asthma&#xD;
&#xD;
          -  autoimmune disease&#xD;
&#xD;
          -  chronic obstructive pulmonary disease&#xD;
&#xD;
          -  heart disease&#xD;
&#xD;
          -  renal disease&#xD;
&#xD;
          -  treatment with prebiotics 1 month before the enrolment&#xD;
&#xD;
          -  treatment with probiotics 1 month before the enrolment&#xD;
&#xD;
          -  treatment with antibiotics (undergoing)&#xD;
&#xD;
          -  treatment with systemic immune-modulators 1 month before the enrolment&#xD;
&#xD;
          -  treatment with local immune-modulators 1 month before the enrolment&#xD;
&#xD;
          -  acute or chronic infectious disease&#xD;
&#xD;
          -  known hypersensitivity to components of fermented rice flour&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>36 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gian Vincenzo Zuccotti, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pediatrics Department Ospedale dei Bambini V. Buzzi Milano</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Enza Carmina D'Auria, MD, PhD</last_name>
    <email>mailto:enzacarmina.dauria@asst-fbf-sacco.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Pediatrics Department Ospedale dei Bambini V. Buzzi</name>
      <address>
        <city>Milano</city>
        <zip>20154</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Enza Carmina D'Auria, MD, PhD</last_name>
      <email>mailto:enzacarmina.dauria@asst-fbf-sacco.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Elias PM, Steinhoff M. &quot;Outside-to-inside&quot; (and now back to &quot;outside&quot;) pathogenic mechanisms in atopic dermatitis. J Invest Dermatol. 2008 May;128(5):1067-70. doi: 10.1038/jid.2008.88.</citation>
    <PMID>18408746</PMID>
  </reference>
  <reference>
    <citation>Majamaa H, Isolauri E. Probiotics: a novel approach in the management of food allergy. J Allergy Clin Immunol. 1997 Feb;99(2):179-85. doi: 10.1016/s0091-6749(97)70093-9.</citation>
    <PMID>9042042</PMID>
  </reference>
  <reference>
    <citation>Isolauri E, Arvola T, Sutas Y, Moilanen E, Salminen S. Probiotics in the management of atopic eczema. Clin Exp Allergy. 2000 Nov;30(11):1604-10. doi: 10.1046/j.1365-2222.2000.00943.x.</citation>
    <PMID>11069570</PMID>
  </reference>
  <reference>
    <citation>Weston S, Halbert A, Richmond P, Prescott SL. Effects of probiotics on atopic dermatitis: a randomised controlled trial. Arch Dis Child. 2005 Sep;90(9):892-7. doi: 10.1136/adc.2004.060673. Epub 2005 Apr 29.</citation>
    <PMID>15863468</PMID>
  </reference>
  <reference>
    <citation>Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology. 1993;186(1):23-31. doi: 10.1159/000247298.</citation>
    <PMID>8435513</PMID>
  </reference>
  <reference>
    <citation>Agostoni C, Goulet O, Kolacek S, Koletzko B, Moreno L, Puntis J, Rigo J, Shamir R, Szajewska H, Turck D; ESPGHAN Committee on Nutrition. Fermented infant formulae without live bacteria. J Pediatr Gastroenterol Nutr. 2007 Mar;44(3):392-7. doi: 10.1097/01.mpg.0000258887.93866.69.</citation>
    <PMID>17325568</PMID>
  </reference>
  <reference>
    <citation>Zagato E, Mileti E, Massimiliano L, Fasano F, Budelli A, Penna G, Rescigno M. Lactobacillus paracasei CBA L74 metabolic products and fermented milk for infant formula have anti-inflammatory activity on dendritic cells in vitro and protective effects against colitis and an enteric pathogen in vivo. PLoS One. 2014 Feb 10;9(2):e87615. doi: 10.1371/journal.pone.0087615. eCollection 2014.</citation>
    <PMID>24520333</PMID>
  </reference>
  <reference>
    <citation>Beretta S, Fabiano V, Petruzzi M, Budelli A, Zuccotti GV. Fermented rice flour in pediatric atopic dermatitis. Dermatitis. 2015 Mar-Apr;26(2):104-6. doi: 10.1097/DER.0000000000000103. No abstract available.</citation>
    <PMID>25757084</PMID>
  </reference>
  <reference>
    <citation>Schram ME, Spuls PI, Leeflang MM, Lindeboom R, Bos JD, Schmitt J. EASI, (objective) SCORAD and POEM for atopic eczema: responsiveness and minimal clinically important difference. Allergy. 2012 Jan;67(1):99-106. doi: 10.1111/j.1398-9995.2011.02719.x. Epub 2011 Sep 27.</citation>
    <PMID>21951293</PMID>
  </reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>February 2, 2017</last_update_submitted>
  <last_update_submitted_qc>February 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Milan</investigator_affiliation>
    <investigator_full_name>Gian Vincenzo Zuccotti</investigator_full_name>
    <investigator_title>Professor of Pediatrics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
  </condition_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/NCT03042624
org study id: FERCT16
nct id: NCT03042624
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This trial aims at evaluating the efficacy of a fermented rice flour for the treatment of
      atopic dermatitis (AD).

      The fermented rice flour, obtained from Lactobacillus paracasei CBA L74 (Heinz Italia SpA,
      Latina, Italy), does not contain live bacteria. Lactobacillus paracasei CBA L74 belongs to
      the list of microorganisms with qualified presumption of safety compiled by the European Food
      Safety Authority (EFSA), is tested for the absence of antibiotic resistance genes in
      accordance with EFSA, and is genetically characterized by repetitive extragenic palindromic
      polymerase chain reaction.

      Using a repeated-measure cohort design, the investigators have recently shown that the
      administration of a fermented-rice flour obtained from Lactobacillus paracasei CBA L74 was
      associated with a decrease of the score for atopic dermatitis (SCORAD) in children with AD.

      The present randomized, double-blind, controlled trial is aimed at testing whether the
      fermented rice flour obtained from Lactobacillus paracasei CBA L74 is effective in reducing
      SCORAD in children with moderate to severe AD using placebo as comparator.
Atopic dermatitis (AD), an itchy eczema with a chronic relapsing course, is the most common
      clinical manifestation of atopy in the first years of life.

      On the basis of the available knowledge, AD is produced by an alteration of the skin barrier
      which triggers an inflammatory reaction. Such reaction is characterized by an early phase
      with abundance of Th2 cytokines (IL-4, IL-5) and eosinophils and by a later phase with
      predominance of Th1 cytokines (IL-2, IL-12 and IFN-gamma).

      Emollients, possibly supplemented with ceramides, represent the first step of the treatment
      of AD. Corticosteroids are the most effective topical drugs. The use of topical
      immune-modulators (tacrolimus and pimecrolimus) offers an alternative to steroid therapy for
      long-term treatments. Severe cases require systemic therapy with steroids and cyclosporine
      and phototherapy with narrowband ultraviolet (UVB) and psoralen-ultraviolet A (PUVA)
      phototherapy.

      The use of probiotics for the treatment of AD has attracted much interest in recent years but
      the available data are not conclusive. Probiotic-like effects can be obtained from
      inactivated bacteria or isolated bacterial components so that an extensive definition of
      probiotics has been proposed as bacterial cells or bacterial components that have a
      beneficial impact on the health and well-being of guests.

      Using a repeated-measure cohort design, the investigators have recently shown that the
      administration of the fermented-rice flour obtained from Lactobacillus paracasei CBA L74 was
      associated with a decrease of SCORAD (score for atopic dermatitis) in children with AD.

      SCORAD is the most commonly employed indicator of AD activity and its minimal clinically
      important difference is known, making it a suitable metric for clinical trials.

      The fermented rice flour, obtained from Lactobacillus paracasei CBA L74 (Heinz Italia SpA,
      Latina, Italy), does not contain live bacteria. Lactobacillus paracasei CBA L74 belongs to
      the list of microorganisms with qualified presumption of safety compiled by the European Food
      Safety Authority (EFSA), is tested for the absence of antibiotic resistance genes in
      accordance with EFSA, and is genetically characterized by repetitive extragenic palindromic
      polymerase chain reaction.

      Pre-clinical studies have shown anti-inflammatory effects of matrices fermented with
      Lactobacillus paracasei CBA-L74 in terms of production of IL-10 and reduction of IL-12 in
      response to bacterial stimulation. Such pre-clinical data were obtained on dendritic cells,
      on intestinal biopsies and on murine models.

      The present randomized, double-blind, controlled trial is aimed at testing whether the
      fermented rice flour obtained from Lactobacillus paracasei CBA L74 is effective in reducing
      SCORAD in children with moderate to severe AD using placebo as comparator.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel-arm, Randomized, Double-blind Controlled Trial
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: Each treatment is numbered consecutively without any reference to the underlying randomization scheme, which is known only to the statistician who generated the list and to the technician who prepared the packages. The packages and their contents are indistinguishable.
measure: SCORAD change
time frame: 12 weeks
description: The treatment will be stopped at 12 weeks
measure: SCORAD change
time frame: 16 weeks
description: The outcome will be evaluated also 4 weeks after the suspension of treatment
measure: Fecal microbiota composition
time frame: 12 weeks
measure: Cytokine profiling
time frame: 12 weeks
description: Measurement of peripheral IFN-gamma, IL-4, IL-5, IL-10, IL-12, IL-13, IL-18 and IL-31
measure: Peripheral immunophenotyping
time frame: 12 weeks
description: Measurement of peripheral Treg, central memory and effector and Th1/Th2/Th17 cells
measure: Total and specific IgE
time frame: 12 weeks
arm group label: Fermented rice
arm group type: Experimental
description: 7 g of fermented rice flour powder obtained from Lactobacillus paracasei CBA L74 to be diluted in milk or water
arm group label: Maltodextrins
arm group type: Placebo Comparator
description: 7 g of maltodextrins powder to be diluted in milk or water
intervention type: Dietary Supplement
intervention name: Fermented rice
description: 7 g of powder obtained from Lactobacillus paracasei CBA L74
arm group label: Fermented rice
intervention type: Dietary Supplement
intervention name: Maltodextrins
description: 7 g of maltodextrins powder
arm group label: Maltodextrins
criteria: 
gender: All
minimum age: 6 Months
maximum age: 36 Months
healthy volunteers: No
last name: Gian Vincenzo Zuccotti, MD
role: Principal Investigator
affiliation: Pediatrics Department Ospedale dei Bambini V. Buzzi Milano
last name: Enza Carmina D'Auria, MD, PhD
email: mailto:enzacarmina.dauria@asst-fbf-sacco.it
facility: 
status: Recruiting
contact: 
country: Italy
citation: Elias PM, Steinhoff M. "Outside-to-inside" (and now back to "outside") pathogenic mechanisms in atopic dermatitis. J Invest Dermatol. 2008 May;128(5):1067-70. doi: 10.1038/jid.2008.88.
PMID: 18408746
citation: Majamaa H, Isolauri E. Probiotics: a novel approach in the management of food allergy. J Allergy Clin Immunol. 1997 Feb;99(2):179-85. doi: 10.1016/s0091-6749(97)70093-9.
PMID: 9042042
citation: Isolauri E, Arvola T, Sutas Y, Moilanen E, Salminen S. Probiotics in the management of atopic eczema. Clin Exp Allergy. 2000 Nov;30(11):1604-10. doi: 10.1046/j.1365-2222.2000.00943.x.
PMID: 11069570
citation: Weston S, Halbert A, Richmond P, Prescott SL. Effects of probiotics on atopic dermatitis: a randomised controlled trial. Arch Dis Child. 2005 Sep;90(9):892-7. doi: 10.1136/adc.2004.060673. Epub 2005 Apr 29.
PMID: 15863468
citation: Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology. 1993;186(1):23-31. doi: 10.1159/000247298.
PMID: 8435513
citation: Agostoni C, Goulet O, Kolacek S, Koletzko B, Moreno L, Puntis J, Rigo J, Shamir R, Szajewska H, Turck D; ESPGHAN Committee on Nutrition. Fermented infant formulae without live bacteria. J Pediatr Gastroenterol Nutr. 2007 Mar;44(3):392-7. doi: 10.1097/01.mpg.0000258887.93866.69.
PMID: 17325568
citation: Zagato E, Mileti E, Massimiliano L, Fasano F, Budelli A, Penna G, Rescigno M. Lactobacillus paracasei CBA L74 metabolic products and fermented milk for infant formula have anti-inflammatory activity on dendritic cells in vitro and protective effects against colitis and an enteric pathogen in vivo. PLoS One. 2014 Feb 10;9(2):e87615. doi: 10.1371/journal.pone.0087615. eCollection 2014.
PMID: 24520333
citation: Beretta S, Fabiano V, Petruzzi M, Budelli A, Zuccotti GV. Fermented rice flour in pediatric atopic dermatitis. Dermatitis. 2015 Mar-Apr;26(2):104-6. doi: 10.1097/DER.0000000000000103. No abstract available.
PMID: 25757084
citation: Schram ME, Spuls PI, Leeflang MM, Lindeboom R, Bos JD, Schmitt J. EASI, (objective) SCORAD and POEM for atopic eczema: responsiveness and minimal clinically important difference. Allergy. 2012 Jan;67(1):99-106. doi: 10.1111/j.1398-9995.2011.02719.x. Epub 2011 Sep 27.
PMID: 21951293
responsible party type: Principal Investigator
investigator affiliation: University of Milan
investigator full name: Gian Vincenzo Zuccotti
investigator title: Professor of Pediatrics
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
sharing ipd: No