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/NCT05998200</url>
    </required_header>
    <id_info>
      <org_study_id>UMRAMREC001-23</org_study_id>
      <nct_id>NCT05998200</nct_id>
    </id_info>
    <brief_title>Safety of Serum for Post-Inflammatory on Hyperpigmentation Skin</brief_title>
    <official_title>Safety of Serum Containing Alpha Hydroxy Acid (AHA) and Polyglutamate Acid Derivatives for Post-Inflammatory on Hyperpigmentation Skin</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 aims to investigate the safety of serum product containing low dose of alpha&#xD;
        hydroxy acid (AHA) i.e. 1% Glycolic acid and Lactic acid and Polyglutamate acid derivatives&#xD;
        (PGA) for post-inflammatory hyperpigmentation skin in Malaysia. The study duration is 8 weeks&#xD;
        and the skin assessment will be carried out at baseline, week 4 and week 8.The main questions&#xD;
        this study aims to answer are:&#xD;
  &#xD;
          1. To investigate the safety of serum containing low concentration AHA (1% Glycolic acid&#xD;
             and Lactic acid) and PGA for post-inflammatory hyperpigmentation skin among Malaysian.&#xD;
  &#xD;
          2. To assess the patient satisfaction after using serum containing low concentration AHA&#xD;
             (1% Glycolic acid and Lactic acid) and PGA among Malaysian.&#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 30, 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>Adverse effect after using the serum.</measure>
      <time_frame>Week 8</time_frame>
      <description>Based on adverse effect occurrence on participants that occur during study period (8 weeks)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in skin moisture level</measure>
      <time_frame>Baseline, Week 4 and Week 8</time_frame>
      <description>Skin moisture will be measure using JANUS III skin analyzer and the changes in skin moisture from baseline and at week 4 and week 8 will be compared.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in skin spot level</measure>
      <time_frame>Baseline, Week 4 and Week 8</time_frame>
      <description>Skin spot will be measure using JANUS III skin analyzer and the changes in skin spot from baseline and at week 4 and week 8 will be compared.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in skin pores level</measure>
      <time_frame>Baseline, Week 4 and Week 8</time_frame>
      <description>Skin pores will be measure using JANUS III skin analyzer and the changes in skin pores from baseline and at week 4 and week 8 will be compared.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in skin tone level</measure>
      <time_frame>Baseline, Week 4 and Week 8</time_frame>
      <description>Skin tone will be measure using JANUS III skin analyzer and the changes in skin tone from baseline and at week 4 and week 8 will be compared.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Participant satisfaction after using the serum for 8 week.</measure>
      <time_frame>Week 8</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">34</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGA</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>This serum containing low concentration AHA (1% Glycolic acid and Lactic acid) and PGA.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGA</intervention_name>
      <description>Participants will used the serum twice daily for 8 weeks</description>
      <arm_group_label>Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGA</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Malaysian from 18 to 40 years old.&#xD;
  &#xD;
            -  Participants with post-inflammatory hyperpigmentation (PIH).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participant with known systemic or skin disease and any underlying medical illness&#xD;
  &#xD;
            -  Pregnant, breastfeeding women or planned pregnancy during the study period.&#xD;
  &#xD;
            -  Had reported history of dermatologic conditions (i.e. Atopic dermatitis, psoriasis) or&#xD;
               known allergies to any ingredients that may be found in the product.&#xD;
  &#xD;
            -  Had any cosmetic procedures such as Botox, laser and light treatment, facial surgery,&#xD;
               chemical peel and any procedures that may improve skin texture 1 month before the&#xD;
               study.&#xD;
  &#xD;
            -  Had history of taking isotretinoin for the past 6 or 12 month and AHA (alpha hydroxyl&#xD;
               acids) containing products or any other products for treating hyperpigmentation skin&#xD;
               or melasma 1 month prior to study.&#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 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 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>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Glycolic acid</mesh_term>
    </intervention_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/NCT05998200
  org study id: UMRAMREC001-23
  nct id: NCT05998200
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to investigate the safety of serum product containing low dose of alpha
        hydroxy acid (AHA) i.e. 1% Glycolic acid and Lactic acid and Polyglutamate acid derivatives
        (PGA) for post-inflammatory hyperpigmentation skin in Malaysia. The study duration is 8 weeks
        and the skin assessment will be carried out at baseline, week 4 and week 8.The main questions
        this study aims to answer are:
  
          1. To investigate the safety of serum containing low concentration AHA (1% Glycolic acid
             and Lactic acid) and PGA for post-inflammatory hyperpigmentation skin among Malaysian.
  
          2. To assess the patient satisfaction after using serum containing low concentration AHA
             (1% Glycolic acid and Lactic acid) and PGA among Malaysian.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Adverse effect after using the serum.
  time frame: Week 8
  description: Based on adverse effect occurrence on participants that occur during study period (8 weeks)
  measure: Change in skin moisture level
  time frame: Baseline, Week 4 and Week 8
  description: Skin moisture will be measure using JANUS III skin analyzer and the changes in skin moisture from baseline and at week 4 and week 8 will be compared.
  measure: Change in skin spot level
  time frame: Baseline, Week 4 and Week 8
  description: Skin spot will be measure using JANUS III skin analyzer and the changes in skin spot from baseline and at week 4 and week 8 will be compared.
  measure: Change in skin pores level
  time frame: Baseline, Week 4 and Week 8
  description: Skin pores will be measure using JANUS III skin analyzer and the changes in skin pores from baseline and at week 4 and week 8 will be compared.
  measure: Change in skin tone level
  time frame: Baseline, Week 4 and Week 8
  description: Skin tone will be measure using JANUS III skin analyzer and the changes in skin tone from baseline and at week 4 and week 8 will be compared.
  measure: Participant satisfaction after using the serum for 8 week.
  time frame: Week 8
  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: Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGA
  arm group type: Other
  description: This serum containing low concentration AHA (1% Glycolic acid and Lactic acid) and PGA.
  intervention type: Other
  intervention name: Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGA
  description: Participants will used the serum twice daily for 8 weeks
  arm group label: Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGA
  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
  mesh term: Glycolic acid
  sharing ipd: No