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/NCT06026085</url>
    </required_header>
    <id_info>
      <org_study_id>SKCFRX002</org_study_id>
      <nct_id>NCT06026085</nct_id>
    </id_info>
    <brief_title>A Clinical Study to Evaluate the Efficacy and Satisfaction of the Skinceuticals Skin Care Product (CE FERULIC) for Skin Repair Post Fraxel Laser Treatment</brief_title>
    <official_title>A Prospective, Single-Center, Single-Blind, Randomized Split-Face Controlled Clinical Study to Evaluate the Efficacy and Satisfaction of the Skinceuticals Skin Care Product (CE FERULIC) for Skin Repair Post Fraxel Laser Treatment in Real World Clinical Practice</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>DeYi Aesthetic Medical Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>DeYi Aesthetic Medical Clinic</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        A Prospective, Single-center, Single-blind, Randomized split-face, controlled trial will be&#xD;
        conducted. The goal of this clinical trial is to evaluate the efficacy and satisfaction of&#xD;
        the Skinceuticals skin care product (CE) for skin repair following fraxel laser treatment and&#xD;
        explore the medical value of fraxel laser therapy combined with Skinceuticals skin care&#xD;
        product&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2023</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in erythema score</measure>
      <time_frame>at day 7 post-procedure</time_frame>
      <description>Scoring criteria: 0 (no erythema), 1 (mild erythema), 2 (moderate erythema), and 3 (severe erythema)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in erythema score</measure>
      <time_frame>days 1, 3 post-procedure</time_frame>
      <description>Scoring criteria: 0 (no erythema), 1 (mild erythema), 2 (moderate erythema), and 3 (severe erythema)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in edema score</measure>
      <time_frame>days 1, 3,7 post-procedure</time_frame>
      <description>Score 0 - no edema, score 1 - mild edema, score 2 - moderate edema, score 3 - severe edema</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in Erythema Index (EI)</measure>
      <time_frame>days 1, 3,7 post-procedure</time_frame>
      <description>EI values were measured on both sides of their faces with a multifunctional skin tester MPA20 (Courage Khazaka, Germany) + Mexameter MX18 probe</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in melanin index(MI)</measure>
      <time_frame>days 1, 3,7 post-procedure</time_frame>
      <description>MI values were measured on both sides of their faces with a multifunctional skin tester MPA20 (Courage Khazaka, Germany) + Mexameter MX18 probe</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in stratum corneum water content</measure>
      <time_frame>days 1, 3,7 post-procedure</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in transepidermal water loss</measure>
      <time_frame>days 1, 3,7 post-procedure</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in sebum rate</measure>
      <time_frame>days 1, 3,7 post-procedure</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Subjects overall satisfaction</measure>
      <time_frame>days 1, 3,7 post-procedure</time_frame>
      <description>Satisfaction ratings were classified as: very satisfied, satisfied, dissatisfied, very dissatisfied</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Scab and desquamation</measure>
      <time_frame>days 1, 3,7 post-procedure</time_frame>
      <description>Record the start scab formation time, start scab removal time and complete scab removal time of subjects</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Photo-damaging</condition>
    <arm_group>
      <arm_group_label>CE FERULIC</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>fraxel laser therapy combined with Skinceuticals skin care product(CE FERULIC) and routine sun protection</description>
    </arm_group>
    <arm_group>
      <arm_group_label>0.9% normal saline</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>fraxel laser therapy combined with 0.9% normal saline and routine sun protection</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Skinceuticals skin care product(CE)</intervention_name>
      <description>Skinceuticals skin care product(CE FERULIC)+routine sun protection</description>
      <arm_group_label>CE FERULIC</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>fraxel laser therapy</intervention_name>
      <description>Fraxel DUAL 1550/1927 Laser System</description>
      <arm_group_label>0.9% normal saline</arm_group_label>
      <arm_group_label>CE FERULIC</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>0.9% normal saline</intervention_name>
      <description>0.9% normal saline+routine sun protection</description>
      <arm_group_label>0.9% normal saline</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Chinese subjects aged 18-65 years (inclusive);&#xD;
  &#xD;
            2. Subjects with Fitzpatrick skin type II-IV;&#xD;
  &#xD;
            3. Subjects with mild to moderate facial photoaging lesions, including melasma, acne&#xD;
               scars, fine skin lines, enlarged pores, and dark photoaging problems&#xD;
  &#xD;
            4. Subjects with consistent facial skin status on both sides and planned to receive&#xD;
               fraxel laser treatment;&#xD;
  &#xD;
            5. Subjects are willing to follow the requirements of the study protocol and complete the&#xD;
               corresponding procedures;&#xD;
  &#xD;
            6. Subjects understand the nature of the study and sign the informed consent form (ICF)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subjects with photosensitive skin or photosensitization-related diseases;&#xD;
  &#xD;
            2. Subjects with a history of skin pigmentation, such as pigmentation caused by sex&#xD;
               hormone factors (pregnancy, oral contraceptives);&#xD;
  &#xD;
            3. Subjects with hypertrophic scar or scar constitution;&#xD;
  &#xD;
            4. Subjects with autoimmune diseases, endocrine diseases or liver diseases that may lead&#xD;
               to skin color changes;&#xD;
  &#xD;
            5. Subjects who have received steroid/phototoxic drugs or laser treatment on the face&#xD;
               within 3 months before enrollment;&#xD;
  &#xD;
            6. Subjects with a history of sun exposure within 2 weeks prior to enrollment;&#xD;
  &#xD;
            7. Subjects who are known to be contraindicated to fraxel laser therapy or CE (or&#xD;
               allergic to other skin care components);&#xD;
  &#xD;
            8. Subjects with known infection and inflammation in the intended treatment site;&#xD;
  &#xD;
            9. Female subjects who are pregnant, lactating or plan to become pregnant;&#xD;
  &#xD;
           10. Subjects who plan to use other drugs affecting skin color or intend to undergo other&#xD;
               laser therapy and sunbathing during the treatment;&#xD;
  &#xD;
           11. Subjects who are participating in other drug or medical device clinical trials;&#xD;
  &#xD;
           12. Other subjects who are not suitable for this study as assessed by the investigator&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- 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/NCT06026085
  org study id: SKCFRX002
  nct id: NCT06026085
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  A Prospective, Single-center, Single-blind, Randomized split-face, controlled trial will be
        conducted. The goal of this clinical trial is to evaluate the efficacy and satisfaction of
        the Skinceuticals skin care product (CE) for skin repair following fraxel laser treatment and
        explore the medical value of fraxel laser therapy combined with Skinceuticals skin care
        product
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Change in erythema score
  time frame: at day 7 post-procedure
  description: Scoring criteria: 0 (no erythema), 1 (mild erythema), 2 (moderate erythema), and 3 (severe erythema)
  measure: Change from baseline in erythema score
  time frame: days 1, 3 post-procedure
  description: Scoring criteria: 0 (no erythema), 1 (mild erythema), 2 (moderate erythema), and 3 (severe erythema)
  measure: Change from baseline in edema score
  time frame: days 1, 3,7 post-procedure
  description: Score 0 - no edema, score 1 - mild edema, score 2 - moderate edema, score 3 - severe edema
  measure: Change from baseline in Erythema Index (EI)
  time frame: days 1, 3,7 post-procedure
  description: EI values were measured on both sides of their faces with a multifunctional skin tester MPA20 (Courage Khazaka, Germany) + Mexameter MX18 probe
  measure: Change from baseline in melanin index(MI)
  time frame: days 1, 3,7 post-procedure
  description: MI values were measured on both sides of their faces with a multifunctional skin tester MPA20 (Courage Khazaka, Germany) + Mexameter MX18 probe
  measure: Change from baseline in stratum corneum water content
  time frame: days 1, 3,7 post-procedure
  measure: Change from baseline in transepidermal water loss
  time frame: days 1, 3,7 post-procedure
  measure: Change from baseline in sebum rate
  time frame: days 1, 3,7 post-procedure
  measure: Subjects overall satisfaction
  time frame: days 1, 3,7 post-procedure
  description: Satisfaction ratings were classified as: very satisfied, satisfied, dissatisfied, very dissatisfied
  measure: Scab and desquamation
  time frame: days 1, 3,7 post-procedure
  description: Record the start scab formation time, start scab removal time and complete scab removal time of subjects
  arm group label: CE FERULIC
  arm group type: Experimental
  description: fraxel laser therapy combined with Skinceuticals skin care product(CE FERULIC) and routine sun protection
  arm group label: 0.9% normal saline
  arm group type: Placebo Comparator
  description: fraxel laser therapy combined with 0.9% normal saline and routine sun protection
  intervention type: Other
  intervention name: Skinceuticals skin care product(CE)
  description: Skinceuticals skin care product(CE FERULIC)+routine sun protection
  arm group label: CE FERULIC
  intervention type: Other
  intervention name: fraxel laser therapy
  description: Fraxel DUAL 1550/1927 Laser System
  arm group label: 0.9% normal saline
  arm group label: CE FERULIC
  intervention type: Other
  intervention name: 0.9% normal saline
  description: 0.9% normal saline+routine sun protection
  arm group label: 0.9% normal saline
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Sponsor