<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/NCT03040089</url>
  </required_header>
  <id_info>
    <org_study_id>LTN-03</org_study_id>
    <nct_id>NCT03040089</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Picosecond, Neodymium-doped Yttrium Aluminum Garnet Laser Therapy Using 1,064 nm and 595 nm</brief_title>
  <official_title>Efficacy and Safety of Picosecond, Neodymium-doped Yttrium Aluminum Garnet Laser Laser Therapy Using 1,064 nm and 595 nm on Patients With Melasma: A Prospective, Multi-center, Split Face, 2% Hydroquinone Cream-controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LUTRONIC Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LUTRONIC Corporation</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 is a prospective, multi-center, split-face, controlled clinical trial that aims to&#xD;
      investigate the efficacy and safety of picosecond, neodymium-doped yttrium aluminum garnet&#xD;
      laser laser therapy on patients with melasma, compared with 2% hydroquinone cream. The trial&#xD;
      will be performed by two Korean institutions on 45 subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 9, 2016</start_date>
  <completion_date type="Actual">September 26, 2016</completion_date>
  <primary_completion_date type="Actual">July 15, 2016</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>Success rate of treatment according to RL*I</measure>
    <time_frame>Baseline, 1 week after final treatment</time_frame>
    <description>The success rate is determined by the change rate (%) of the relative lightness measured before the treatment (day of screening) and 1 week after the final treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relative skin lightness using the colorimeter(RL*I)</measure>
    <time_frame>Baseline, 1 week, 4 weeks, and 12 weeks after the final treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mMASI (modified Melasma Area Severity Index) evaluation</measure>
    <time_frame>Baseline, 1 week, 4 weeks, 8 weeks, and 12 weeks after the final treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject satisfaction (5-point scale questionnaires on subject's satisfaction)</measure>
    <time_frame>1 week and 12 weeks after the final treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Melasma</condition>
  <arm_group>
    <arm_group_label>picosecond laser &amp; 2% hydroquinone cream</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PICO+4 laser system and Neoquine Cream 2% (2% hydroquinone cream) for melasma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2% hydroquinone cream</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Only Neoquine Cream 2% (2% hydroquinone cream) for melasma</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PICO+4</intervention_name>
    <description>picosecond, neodymium-doped yttrium aluminum garnet laser</description>
    <arm_group_label>picosecond laser &amp; 2% hydroquinone cream</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Neoquine Cream 2%</intervention_name>
    <description>2% hydroquinone cream</description>
    <arm_group_label>2% hydroquinone cream</arm_group_label>
    <arm_group_label>picosecond laser &amp; 2% hydroquinone cream</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females between the ages of 19 and 74&#xD;
&#xD;
          -  Has Fitzpatrick Skin Type III-V&#xD;
&#xD;
          -  Diagnosed with moderate to severe (GSS ≧ 2) melasma lesions&#xD;
&#xD;
          -  Agreed to the prohibition of the use of local/systemic corticosteroids or retinoids&#xD;
             and other local/systemic lightening medications, and willing to abide by such&#xD;
             instructions&#xD;
&#xD;
          -  Agreed to use the same facial skin care products during the clinical trial period&#xD;
             (including the follow-up period), and willing to abide by such instructions&#xD;
&#xD;
          -  Agreed to the daily use of an over SPF 50 sunblock on their face during the clinical&#xD;
             trial period (including the follow-up period), and willing to abide by such&#xD;
             instructions&#xD;
&#xD;
          -  Agreed to have their face photographed&#xD;
&#xD;
          -  (In case of fertile women) Tested negative in the pregnancy test and agreed to use&#xD;
             birth control contraceptives during the clinical trial period&#xD;
&#xD;
               -  Oral contraceptives are forbidden as they may influence the results of the&#xD;
                  clinical study.&#xD;
&#xD;
          -  Agreed not to undergo any other procedure on their face during their participation in&#xD;
             the clinical trial&#xD;
&#xD;
          -  Voluntarily agreed to sign the written consent form and willing to follow the&#xD;
             instructions of the study protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participated in another medical device or medication clinical trial in the last 3&#xD;
             months, or planning to participate in another trial during this trial&#xD;
&#xD;
          -  Received a cosmetic treatment such as laser, light therapy, or surgery in their facial&#xD;
             area in the last 6 months, or have a history of filler treatments using collagen,&#xD;
             hyaluronic acid, or any other material&#xD;
&#xD;
          -  Diagnosed with incurable melisma&#xD;
&#xD;
          -  Has a history of allergic reaction to local anesthesia&#xD;
&#xD;
          -  Has a history of malignant tumors on their face&#xD;
&#xD;
          -  Has skin lesions such as cuts, wounds, or injuries on their face&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
&#xD;
          -  Has an infection, dermatitis, or rash on their face&#xD;
&#xD;
          -  Currently diagnosed with uncontrolled diabetes or a cardiac disorder such as resistant&#xD;
             hypertension&#xD;
&#xD;
          -  Currently diagnosed with anticoagulant disease or taking anticoagulants&#xD;
&#xD;
          -  Has a history of keloid scarring, hypertrophic scarring, or abnormal would healing&#xD;
&#xD;
          -  Has a history of immunodeficiency or intake of immunosuppressants&#xD;
&#xD;
          -  Has a history of leukoplakia, eczema, or psoriasis&#xD;
&#xD;
          -  Has a history of connective tissue diseases such as systemic lupus erythematosus or&#xD;
             scleroderma&#xD;
&#xD;
          -  Has a history of convulsive disorder caused by light&#xD;
&#xD;
          -  Has a history of diseases irritated by heat on their face (e.g., herpes simplex or&#xD;
             herpes zoster)&#xD;
&#xD;
          -  Has a history of radiotherapy or anticancer chemotherapy on their face&#xD;
&#xD;
          -  Has a history of hormonal therapy in the last 3 months (e.g., estrogen, progesterone,&#xD;
             or oral contraceptive)&#xD;
&#xD;
          -  Has a history of use of a lightening medication (hydroquinone, tranexamic acid),&#xD;
             isotretinoid (or retinoid), light-sensitive medication, or steroids in the last 6&#xD;
             months&#xD;
&#xD;
          -  Has excessive facial tanning&#xD;
&#xD;
          -  Other subject assessed as inadequate for the clinical trial by the investigators&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wonserk Kim</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kangbuk Samsung Hospital</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>January 30, 2017</last_update_submitted>
  <last_update_submitted_qc>January 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanosis</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/NCT03040089
org study id: LTN-03
nct id: NCT03040089
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective, multi-center, split-face, controlled clinical trial that aims to
      investigate the efficacy and safety of picosecond, neodymium-doped yttrium aluminum garnet
      laser laser therapy on patients with melasma, compared with 2% hydroquinone cream. The trial
      will be performed by two Korean institutions on 45 subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Success rate of treatment according to RL*I
time frame: Baseline, 1 week after final treatment
description: The success rate is determined by the change rate (%) of the relative lightness measured before the treatment (day of screening) and 1 week after the final treatment.
measure: Relative skin lightness using the colorimeter(RL*I)
time frame: Baseline, 1 week, 4 weeks, and 12 weeks after the final treatment
measure: mMASI (modified Melasma Area Severity Index) evaluation
time frame: Baseline, 1 week, 4 weeks, 8 weeks, and 12 weeks after the final treatment
measure: Subject satisfaction (5-point scale questionnaires on subject's satisfaction)
time frame: 1 week and 12 weeks after the final treatment
arm group label: picosecond laser & 2% hydroquinone cream
arm group type: Experimental
description: PICO+4 laser system and Neoquine Cream 2% (2% hydroquinone cream) for melasma
arm group label: 2% hydroquinone cream
arm group type: Sham Comparator
description: Only Neoquine Cream 2% (2% hydroquinone cream) for melasma
intervention type: Device
intervention name: PICO+4
description: picosecond, neodymium-doped yttrium aluminum garnet laser
arm group label: picosecond laser & 2% hydroquinone cream
intervention type: Drug
intervention name: Neoquine Cream 2%
description: 2% hydroquinone cream
arm group label: 2% hydroquinone cream
arm group label: picosecond laser & 2% hydroquinone cream
criteria: 
gender: Female
minimum age: 19 Years
maximum age: 74 Years
healthy volunteers: No
last name: Wonserk Kim
role: Principal Investigator
affiliation: Kangbuk Samsung Hospital
responsible party type: Sponsor
mesh term: Melanosis
sharing ipd: No