xml: <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/NCT05986123</url>
    </required_header>
    <id_info>
      <org_study_id>UMRAMREC002-23</org_study_id>
      <nct_id>NCT05986123</nct_id>
    </id_info>
    <brief_title>Safety and Efficacy of Topical Cream for Post-inflammatory Hyperpigmentation Skin Among Malaysians</brief_title>
    <official_title>Safety and Efficacy of Topical Cream Containing Natural Plant Extracts, Niacinamide, and Arbutin for Post-inflammatory Hyperpigmentation Skin Among Malaysians</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ungku Shahrin Medical Aesthetic Research &amp; Innovation (USMARI) Centre</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ungku Shahrin Medical Aesthetic Research &amp; Innovation (USMARI) Centre</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 study was conducted to determine safety and efficacy of topically applied cream&#xD;
        containing combination of niacinamide, arbutin, Scutellaria Baicalensis Root Extract,&#xD;
        Centella Asiatica Extract and Camellia Sinensis Leaf Extract for its skin brightening effect&#xD;
        on post-inflammatory hyperpigmentation among the Malaysian population. The study duration is&#xD;
        20 weeks and the skin assessment will be carried out at baseline, week 4, week 8, week 12,&#xD;
        week 16 and week 20.The main questions this study aims to answer are:&#xD;
  &#xD;
          1. To determine the efficacy of topical cream containing natural plant extracts,&#xD;
             niacinamide, and arbutin for post-inflammatory hyperpigmentation among Malaysians.&#xD;
  &#xD;
          2. To investigate the safety of topical cream containing natural plant extracts,&#xD;
             niacinamide, and arbutin for post-inflammatory hyperpigmentation among Malaysians.&#xD;
  &#xD;
          3. To assess the participants satisfaction of using topical cream containing natural plant&#xD;
             extracts, niacinamide, and arbutin for post-inflammatory hyperpigmentation among&#xD;
             Malaysians.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in skin spot level</measure>
      <time_frame>Baseline, week 4, week 8, week 12, week 16 and week 20.</time_frame>
      <description>Skin spot will be assessed using JANUS III skin analyzer.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in hyperpigmentation score</measure>
      <time_frame>Baseline, week 4, week 8, week 12, week 16 and week 20.</time_frame>
      <description>The hyperpigmented skin area will be assessed based on Modified Melasma Area and Severity Index (mMASI) Score. Scoring system of mMASI score: A, Area of involvement is rated from 0 to 6: (0 indicates absent, 1=&lt;10%, 2= 10% to 90%, 3= 30%-49%, 4= 50%-69%, 5= 70% to 89%, 6=90% to 100%). D, Darkness is rated from 0 to 4: 0= absent, 1=slight hyperpigmentation, 2= mild hyperpigmentation, 3= marked hyperpigmentation, 4=severe hyperpigmentation. Total mMASI score range is 0 (clear) to 24 (most severe melasma) and calculated by adding scores (A and D) for 4 areas of the face. The formula for mMASI score = 0.3×A(forehead)×D (forehead)+0.3×A (left malar) ×D (left malar) + 0.3×A(right malar)×D (right malar)+0.1×A(chin)×D (chin).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adverse effect after using the topical cream.</measure>
      <time_frame>Week 20</time_frame>
      <description>Based on adverse effect occurrence on participants that occur during study period (20 weeks)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Participant satisfaction after using the topical cream for 20 weeks.</measure>
      <time_frame>Week 20</time_frame>
      <description>Participation satisfaction will be evaluated using the Physician Global Assessment (PGA) survey. The subjective score of changes in skin conditions including skin wrinkles, dryness, smoothness, moisturizing and brightening effect will be graded as follows: very satisfied, satisfied, neutral, dissatisfied, very dissatisfied.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Topical cream for PIH</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>The topical cream contain combination of niacinamide, arbutin, Scutellaria Baicalensis Root Extract, Centella Asiatica Extract and Camellia Sinensis Leaf Extract.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Topical cream Z for PIH</intervention_name>
      <description>The topical cream Z contain combination of niacinamide, arbutin, Scutellaria Baicalensis Root Extract, Centella Asiatica Extract and Camellia Sinensis Leaf Extract. Participants will used the topical cream twice daily for 20 weeks</description>
      <arm_group_label>Topical cream for PIH</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Malaysia citizen&#xD;
  &#xD;
            -  Healthy adult, aged between 18 to 40 years old.&#xD;
  &#xD;
            -  Participants who have post-inflammatory hyperpigmentation on skin&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participants with skin disorders such as skin infection or skin inflammation.&#xD;
  &#xD;
            -  Participants who have undergone any skin and cosmetic treatments such as dermal&#xD;
               fillers, botox, laser, chemical peels within the last 3 months.&#xD;
  &#xD;
            -  Participant who is taking isotretinoin for the past 6 or 12 months and&#xD;
               immunocompromised patients.&#xD;
  &#xD;
            -  Pregnant, breastfeeding women or planned for pregnancy during the study period.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Ungku Shahrin Medical Aesthetic Research &amp; Innovation (USMARI) Centre</name>
        <address>
          <city>Petaling Jaya</city>
          <state>Selangor</state>
          <zip>47810</zip>
          <country>Malaysia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>SITI NUR HANIS MAMOOD</last_name>
        <phone>+60167572670</phone>
        <email>hanis@usmari.org.my</email>
      </contact>
      <contact_backup>
        <last_name>Nur Izzati Abdul Rashid</last_name>
        <phone>+60167252670</phone>
        <email>izzati@usmari.org.my</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Malaysia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Aesthetic</keyword>
    <keyword>Cosmetic</keyword>
    <keyword>Post-inflammatory hyperpigmentation (PIH)</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hyperpigmentation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05986123
  org study id: UMRAMREC002-23
  nct id: NCT05986123
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study was conducted to determine safety and efficacy of topically applied cream
        containing combination of niacinamide, arbutin, Scutellaria Baicalensis Root Extract,
        Centella Asiatica Extract and Camellia Sinensis Leaf Extract for its skin brightening effect
        on post-inflammatory hyperpigmentation among the Malaysian population. The study duration is
        20 weeks and the skin assessment will be carried out at baseline, week 4, week 8, week 12,
        week 16 and week 20.The main questions this study aims to answer are:
  
          1. To determine the efficacy of topical cream containing natural plant extracts,
             niacinamide, and arbutin for post-inflammatory hyperpigmentation among Malaysians.
  
          2. To investigate the safety of topical cream containing natural plant extracts,
             niacinamide, and arbutin for post-inflammatory hyperpigmentation among Malaysians.
  
          3. To assess the participants satisfaction of using topical cream containing natural plant
             extracts, niacinamide, and arbutin for post-inflammatory hyperpigmentation among
             Malaysians.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Change in skin spot level
  time frame: Baseline, week 4, week 8, week 12, week 16 and week 20.
  description: Skin spot will be assessed using JANUS III skin analyzer.
  measure: Change in hyperpigmentation score
  time frame: Baseline, week 4, week 8, week 12, week 16 and week 20.
  description: The hyperpigmented skin area will be assessed based on Modified Melasma Area and Severity Index (mMASI) Score. Scoring system of mMASI score: A, Area of involvement is rated from 0 to 6: (0 indicates absent, 1=<10%, 2= 10% to 90%, 3= 30%-49%, 4= 50%-69%, 5= 70% to 89%, 6=90% to 100%). D, Darkness is rated from 0 to 4: 0= absent, 1=slight hyperpigmentation, 2= mild hyperpigmentation, 3= marked hyperpigmentation, 4=severe hyperpigmentation. Total mMASI score range is 0 (clear) to 24 (most severe melasma) and calculated by adding scores (A and D) for 4 areas of the face. The formula for mMASI score = 0.3×A(forehead)×D (forehead)+0.3×A (left malar) ×D (left malar) + 0.3×A(right malar)×D (right malar)+0.1×A(chin)×D (chin).
  measure: Adverse effect after using the topical cream.
  time frame: Week 20
  description: Based on adverse effect occurrence on participants that occur during study period (20 weeks)
  measure: Participant satisfaction after using the topical cream for 20 weeks.
  time frame: Week 20
  description: Participation satisfaction will be evaluated using the Physician Global Assessment (PGA) survey. The subjective score of changes in skin conditions including skin wrinkles, dryness, smoothness, moisturizing and brightening effect will be graded as follows: very satisfied, satisfied, neutral, dissatisfied, very dissatisfied.
  arm group label: Topical cream for PIH
  arm group type: Other
  description: The topical cream contain combination of niacinamide, arbutin, Scutellaria Baicalensis Root Extract, Centella Asiatica Extract and Camellia Sinensis Leaf Extract.
  intervention type: Other
  intervention name: Topical cream Z for PIH
  description: The topical cream Z contain combination of niacinamide, arbutin, Scutellaria Baicalensis Root Extract, Centella Asiatica Extract and Camellia Sinensis Leaf Extract. Participants will used the topical cream twice daily for 20 weeks
  arm group label: Topical cream for PIH
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Malaysia
  responsible party type: Sponsor
  mesh term: Hyperpigmentation
  sharing ipd: No