<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/NCT01687556</url>
  </required_header>
  <id_info>
    <org_study_id>04-2005-043-0</org_study_id>
    <nct_id>NCT01687556</nct_id>
  </id_info>
  <brief_title>EGCG Improves Acne by Modulating Molecular Targets</brief_title>
  <acronym>EGCG</acronym>
  <official_title>Epigallocatechin-3-Gallate Improves Acne in Humans by Modulating Intracellular Molecular Targets and Inhibiting P. Acnes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Epigallocatechin-3-gallate (EGCG) may improve acne vulgaris&#xD;
&#xD;
        -  major polyphenolic constituent in green tea&#xD;
&#xD;
        -  known as potent anti-carcinogenic, anti-inflammatory, anti-proliferative, and&#xD;
           antimicrobial activities&#xD;
&#xD;
        -  lipid-lowering and antiandrogenic properties was reported&#xD;
&#xD;
        -  EGCG can improve acne vulgaris via one of the above mentioned actions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acne vulgaris is one of the most prevalent skin disorders of sebaceous follicles, affecting&#xD;
      more than 85% of adolescents in United States. Acne can persist throughout the adulthood, and&#xD;
      even a mild form of acne might progress to permanent scarring on the face, chest and back,&#xD;
      thereby causing significant physical and psychosocial morbidities. Acne is a multifactorial&#xD;
      disease of which etiology has not been fully elucidated, although considerable progress has&#xD;
      been made in understanding its pathogenesis during last decade. The major pathogenic features&#xD;
      of acne include abnormal ductal keratinization, sebum overproduction, Propionibacterium&#xD;
      acnes, and inflammation. Common acne medications such as topical retinoids, antibiotics and&#xD;
      isotretinoin are associated with irritation and incomplete responses, increased bacterial&#xD;
      resistance or untoward side events, respectively. Thus there is a continuing need for a&#xD;
      novel, effective agent targeting different aspects of acne pathogenesis, with minimal side&#xD;
      effects.&#xD;
&#xD;
      In the recent decade, epigallocatechin-3-gallate (EGCG), the major polyphenolic constituent&#xD;
      in green tea, has attracted much interest on account of its potent anti-carcinogenic,&#xD;
      anti-inflammatory, anti-proliferative, and antimicrobial activities. Preclinical,&#xD;
      observational, and clinical trial data have indicated that EGCG can inhibit tumor initiation,&#xD;
      promotion, progression, and angiogenesis. EGCG also suppresses neutrophil chemotaxis, and has&#xD;
      been suggested to improve many diseases that have inflammatory components such as diabetes,&#xD;
      kidney injuries, arthritis, allergies, dental caries, cardiovascular, gastrointestinal, and&#xD;
      neurodegenerative diseases. In skin, EGCG has been investigated mainly in light of&#xD;
      antioxidative, immunopotentiating and anticarcinogenic properties against chemicals or&#xD;
      ultraviolet irradiation. Moreover, EGCG has lipid-lowering and antiandrogenic properties, and&#xD;
      can downregulate peroxisome proliferator-activated receptor-γ expression. Based on these&#xD;
      observations, it can be inferred that EGCG might be effective in the treatment of acne.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2005</start_date>
  <completion_date type="Actual">June 2006</completion_date>
  <primary_completion_date type="Actual">June 2006</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of acne severity</measure>
    <time_frame>8 week after baseline</time_frame>
    <description>Lesion counts of non-inflammatory lesions (closed comedone, open comedone) and severity measured by Reeds revised scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>2-mm punch biopsy of acne lesion on the EGCG-treated sides</measure>
    <time_frame>8 week after baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Standardized clinical photographs</measure>
    <time_frame>8 week after baseline</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Acne Vulgaris</condition>
  <arm_group>
    <arm_group_label>Topical EGCG 1%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Seventeen subjects were designated to use 1% EGCG .Since baseline visits, affected areas of randomly allocated half sides were treated with 1% solution twice daily, whereas those of the opposite sides were treated with vehicle only (3% ethanol).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>topical EGCG 5%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eighteen subjects were designated to use 5% EGCG, to evaluate a dose-response relationship. Since baseline visits, affected areas of randomly allocated half sides were treated with 5% EGCG solution twice daily, whereas those of the opposite sides were treated with vehicle only (3% ethanol).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>topical EGCG application on acne</intervention_name>
    <description>two times application of topical EGCG on acne lesion</description>
    <arm_group_label>Topical EGCG 1%</arm_group_label>
    <arm_group_label>topical EGCG 5%</arm_group_label>
    <other_name>Green tea extract, EGCG</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age of at least 15 years&#xD;
&#xD;
          -  clinical diagnosis of mild to moderate acne vulgaris&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known pregnancy or lactation&#xD;
&#xD;
          -  any medical illness that might influence the results of the study,&#xD;
&#xD;
          -  a previous history of oral acne medication or surgical procedures including laser&#xD;
             treatment within 6 month and topical medication within 4 weeks of study enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dae Hun Suh, M.D., Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Department of Dermatology, Seoul National University College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Dermatology, Seoul National University College of Medicine,</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Dominguez J, Hojyo MT, Celayo JL, Dominguez-Soto L, Teixeira F. Topical isotretinoin vs. topical retinoic acid in the treatment of acne vulgaris. Int J Dermatol. 1998 Jan;37(1):54-5. doi: 10.1046/j.1365-4362.1998.00254.x.</citation>
    <PMID>9522243</PMID>
  </reference>
  <reference>
    <citation>Abe I, Seki T, Umehara K, Miyase T, Noguchi H, Sakakibara J, Ono T. Green tea polyphenols: novel and potent inhibitors of squalene epoxidase. Biochem Biophys Res Commun. 2000 Feb 24;268(3):767-71. doi: 10.1006/bbrc.2000.2217.</citation>
    <PMID>10679280</PMID>
  </reference>
  <reference>
    <citation>Alexis AF, Jones VA, Stiller MJ. Potential therapeutic applications of tea in dermatology. Int J Dermatol. 1999 Oct;38(10):735-43. doi: 10.1046/j.1365-4362.1999.00796.x. No abstract available.</citation>
    <PMID>10561043</PMID>
  </reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>July 23, 2010</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>September 13, 2012</last_update_submitted>
  <last_update_submitted_qc>September 13, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Dae Hun Suh</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>EGCG</keyword>
  <keyword>green tea</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acne Vulgaris</mesh_term>
  </condition_browse>
  <!-- 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/NCT01687556
org study id: 04-2005-043-0
nct id: NCT01687556
lead sponsor: 
has dmc: No
Epigallocatechin-3-gallate (EGCG) may improve acne vulgaris

        -  major polyphenolic constituent in green tea

        -  known as potent anti-carcinogenic, anti-inflammatory, anti-proliferative, and
           antimicrobial activities

        -  lipid-lowering and antiandrogenic properties was reported

        -  EGCG can improve acne vulgaris via one of the above mentioned actions.
Acne vulgaris is one of the most prevalent skin disorders of sebaceous follicles, affecting
      more than 85% of adolescents in United States. Acne can persist throughout the adulthood, and
      even a mild form of acne might progress to permanent scarring on the face, chest and back,
      thereby causing significant physical and psychosocial morbidities. Acne is a multifactorial
      disease of which etiology has not been fully elucidated, although considerable progress has
      been made in understanding its pathogenesis during last decade. The major pathogenic features
      of acne include abnormal ductal keratinization, sebum overproduction, Propionibacterium
      acnes, and inflammation. Common acne medications such as topical retinoids, antibiotics and
      isotretinoin are associated with irritation and incomplete responses, increased bacterial
      resistance or untoward side events, respectively. Thus there is a continuing need for a
      novel, effective agent targeting different aspects of acne pathogenesis, with minimal side
      effects.

      In the recent decade, epigallocatechin-3-gallate (EGCG), the major polyphenolic constituent
      in green tea, has attracted much interest on account of its potent anti-carcinogenic,
      anti-inflammatory, anti-proliferative, and antimicrobial activities. Preclinical,
      observational, and clinical trial data have indicated that EGCG can inhibit tumor initiation,
      promotion, progression, and angiogenesis. EGCG also suppresses neutrophil chemotaxis, and has
      been suggested to improve many diseases that have inflammatory components such as diabetes,
      kidney injuries, arthritis, allergies, dental caries, cardiovascular, gastrointestinal, and
      neurodegenerative diseases. In skin, EGCG has been investigated mainly in light of
      antioxidative, immunopotentiating and anticarcinogenic properties against chemicals or
      ultraviolet irradiation. Moreover, EGCG has lipid-lowering and antiandrogenic properties, and
      can downregulate peroxisome proliferator-activated receptor-γ expression. Based on these
      observations, it can be inferred that EGCG might be effective in the treatment of acne.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Assessment of acne severity
time frame: 8 week after baseline
description: Lesion counts of non-inflammatory lesions (closed comedone, open comedone) and severity measured by Reeds revised scale
measure: 2-mm punch biopsy of acne lesion on the EGCG-treated sides
time frame: 8 week after baseline
measure: Standardized clinical photographs
time frame: 8 week after baseline
arm group label: Topical EGCG 1%
arm group type: Active Comparator
description: Seventeen subjects were designated to use 1% EGCG .Since baseline visits, affected areas of randomly allocated half sides were treated with 1% solution twice daily, whereas those of the opposite sides were treated with vehicle only (3% ethanol).
arm group label: topical EGCG 5%
arm group type: Experimental
description: Eighteen subjects were designated to use 5% EGCG, to evaluate a dose-response relationship. Since baseline visits, affected areas of randomly allocated half sides were treated with 5% EGCG solution twice daily, whereas those of the opposite sides were treated with vehicle only (3% ethanol).
intervention type: Other
intervention name: topical EGCG application on acne
description: two times application of topical EGCG on acne lesion
arm group label: Topical EGCG 1%
arm group label: topical EGCG 5%
other name: Green tea extract, EGCG
criteria: 
gender: All
minimum age: 15 Years
maximum age: 40 Years
healthy volunteers: No
last name: Dae Hun Suh, M.D., Ph.D.
role: Study Director
affiliation: Department of Dermatology, Seoul National University College of Medicine
facility: 
country: Korea, Republic of
citation: Dominguez J, Hojyo MT, Celayo JL, Dominguez-Soto L, Teixeira F. Topical isotretinoin vs. topical retinoic acid in the treatment of acne vulgaris. Int J Dermatol. 1998 Jan;37(1):54-5. doi: 10.1046/j.1365-4362.1998.00254.x.
PMID: 9522243
citation: Abe I, Seki T, Umehara K, Miyase T, Noguchi H, Sakakibara J, Ono T. Green tea polyphenols: novel and potent inhibitors of squalene epoxidase. Biochem Biophys Res Commun. 2000 Feb 24;268(3):767-71. doi: 10.1006/bbrc.2000.2217.
PMID: 10679280
citation: Alexis AF, Jones VA, Stiller MJ. Potential therapeutic applications of tea in dermatology. Int J Dermatol. 1999 Oct;38(10):735-43. doi: 10.1046/j.1365-4362.1999.00796.x. No abstract available.
PMID: 10561043
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Dae Hun Suh
investigator title: Professor
mesh term: Acne Vulgaris