<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/NCT03826277</url>
  </required_header>
  <id_info>
    <org_study_id>19/1-SK-KPS</org_study_id>
    <nct_id>NCT03826277</nct_id>
  </id_info>
  <brief_title>Efficacy of Melanostop Peeling for Improvement of Melasma</brief_title>
  <acronym>VIMEL</acronym>
  <official_title>The Efficacy of Melanostop Peel in Combination With Specifically Selected Home Care Regimen for Improvement of Melasma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VIST - Faculty of Applied Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VIST - Faculty of Applied Sciences</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>
      Participants with face melasma will receive 4 Melanostop peel treatments containing 20%&#xD;
      azelaic acid, 10% resorcinol and 6% phytic acid. Peels will be performed at 2-week interval.&#xD;
      They will also receive a facial tonic and cream for at home use, containing brightening&#xD;
      ingredients: vitamin C, niacinamide, alpha arbutin, kojic acid. They will also receive&#xD;
      sunscreen protection cream with SPF 50, protecting against UVA, UVB, HEV and IR. Products for&#xD;
      at home use will be used twice a day, every day. Measurements will be made at baseline, on&#xD;
      the day of the forth peel treatment and 4 weeks after the last peel. Measured parameters will&#xD;
      be: mMASI score, VisioFace photography analysis, melasma area measurements, and melanin&#xD;
      index, ΔE, CIELab colour measurements with Cortex SkinLab Combo (Cortex Technology Asp,&#xD;
      Denmark).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">August 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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Modified Melasma Area and Severity Index (mMASI)</measure>
    <time_frame>week 1, week 7, week 11</time_frame>
    <description>Melasma severity will be evaluated according to Modified Melasma Area and Severity Index (mMASI). Significant change of the mMASI score from baseline is expected bfore 4th and one month after 4th Melanostop peel treatments.&#xD;
mMASI score is calculated by first assesing the hyperpigmented area of the face. Four areas are evaluated: forehead (F), right malar region (RM), left malar region(LM), and chin (C), corresponding to 30%, 30%, 30% and 10% of the total face. The melasma in each of the four areas is given a numerical value by rating darkness (D) and area of involvement (A).&#xD;
Scoring system: Area of involvement (A), rated 0 to 6: 0= absent; 1 = &lt;10%; 2 = 10% to 29%; 3 = 30% to 49%; 4= 50% to 69%; 5= 70% to 89%; 6= 90% to 100%. Darkness (D), rated 0 to 4: 0= absent; 1= slight; 2= mild; 3= marked; 4= severe.&#xD;
mMASI total score = (0,3 x A(F) x D(F) ) + (0,3 x A(LM) x D(LM)) + (0,3 x A(RM) x D(RM)) + (0,1 x A(C) x D(C))&#xD;
Total mMASI score range: 0 - 24</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Colour difference</measure>
    <time_frame>week 1, week 7, week 11</time_frame>
    <description>CIE Lab colour will be measured within the lesion and on the control area outside of the lesion using Cortex Dermalab Combo and colour difference (delta E) will be calculated between the areas and in comparison to baseline values.&#xD;
Significant change of the melasma colour from baseline and in comparison to control area is expected after 4 Melanostop peel treatments.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Melanin index change</measure>
    <time_frame>week 1, week 7, week 11</time_frame>
    <description>Melanin index will be measured within the lesion and on the control area outside of the lesion using Cortex Dermalab Combo Skin colour probe. Melanin index is given on a scale 0.0-99.9.&#xD;
Significant change of the melanin index from baseline and in comparison to control area is expected before 4th Melanostop peel treatments and 4 weeks after last treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area of the melasma</measure>
    <time_frame>week 1, week 7, week 11</time_frame>
    <description>Melasma area will be measured using Visioface photography analysis. Significant change of the melasma area from baseline is expected before 4th Melanostop peel treatments and 4 weeks after last treatment.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Melasma</condition>
  <arm_group>
    <arm_group_label>Melanostop peel treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adult women aged between 20-50 years old.&#xD;
Melasma on the face&#xD;
Fitzpatrick phototypes I-IV&#xD;
Presenting facial melasma&#xD;
In good health condition</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Melanostop peel</intervention_name>
    <description>Melanostop peel treatments containing 20% azelaic acid, 10% resorcinol, 6% phytic acid, 3% tranexamic acid. (4 treatments, performed at 2-week intervals), in combination with home care products (twice daily):&#xD;
a facial tonic and cream containing brightening ingredients: vitamin C, niacinamide, alpha arbutin, kojic acid,&#xD;
sunscreen protection cream with SPF 50, protecting against UVA, UVB, HEV and IR</description>
    <arm_group_label>Melanostop peel treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult women aged between 20-50 years old.&#xD;
&#xD;
          -  Melasma on the face&#xD;
&#xD;
          -  Fitzpatrick phototypes I-IV&#xD;
&#xD;
          -  Presenting facial melasma&#xD;
&#xD;
          -  In good health condition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Breastfeeding and pregnancy&#xD;
&#xD;
          -  Women presenting oral herpes&#xD;
&#xD;
          -  Other skin diseases, arthritis, diabetes, diseases of thyroid gland&#xD;
&#xD;
          -  Any known allergies to ingredients of the products used in the study&#xD;
&#xD;
          -  Systemic or topical use of corticosteroids in the previous 6 months&#xD;
&#xD;
          -  Antiaging or lightening cosmetic/estetic procedures in the last 2 months (for example:&#xD;
             laser or IPL treatments, chemical peels,..)&#xD;
&#xD;
          -  Taking drugs for skin lightening in the previous 2 months&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Lesions of unknown origin&#xD;
&#xD;
          -  Oral or topical use of isotretinoin in the previous 6 months&#xD;
&#xD;
          -  Active bacterial, viral or fungal infections of the skin&#xD;
&#xD;
          -  Presence of keloid scars&#xD;
&#xD;
          -  Immunodeficiency&#xD;
&#xD;
          -  Moderate to severe acne&#xD;
&#xD;
          -  Planned change in hormonal contraception or taking drugs that have an affect on&#xD;
             hormonal balance during the course of the study&#xD;
&#xD;
          -  Unrealistic expectations&#xD;
&#xD;
          -  Refusal to use sunscreen protection and complying with instructions&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>women</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katja Žmitek, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Head of Reasearch Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Higher School of Applied Sciences, Institute of Cosmetics</name>
      <address>
        <city>Ljubljana</city>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Slovenia</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>April 25, 2023</last_update_submitted>
  <last_update_submitted_qc>April 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2023</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/NCT03826277
org study id: 19/1-SK-KPS
nct id: NCT03826277
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Participants with face melasma will receive 4 Melanostop peel treatments containing 20%
      azelaic acid, 10% resorcinol and 6% phytic acid. Peels will be performed at 2-week interval.
      They will also receive a facial tonic and cream for at home use, containing brightening
      ingredients: vitamin C, niacinamide, alpha arbutin, kojic acid. They will also receive
      sunscreen protection cream with SPF 50, protecting against UVA, UVB, HEV and IR. Products for
      at home use will be used twice a day, every day. Measurements will be made at baseline, on
      the day of the forth peel treatment and 4 weeks after the last peel. Measured parameters will
      be: mMASI score, VisioFace photography analysis, melasma area measurements, and melanin
      index, ΔE, CIELab colour measurements with Cortex SkinLab Combo (Cortex Technology Asp,
      Denmark).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Modified Melasma Area and Severity Index (mMASI)
time frame: week 1, week 7, week 11
description: Melasma severity will be evaluated according to Modified Melasma Area and Severity Index (mMASI). Significant change of the mMASI score from baseline is expected bfore 4th and one month after 4th Melanostop peel treatments.
mMASI score is calculated by first assesing the hyperpigmented area of the face. Four areas are evaluated: forehead (F), right malar region (RM), left malar region(LM), and chin (C), corresponding to 30%, 30%, 30% and 10% of the total face. The melasma in each of the four areas is given a numerical value by rating darkness (D) and area of involvement (A).
Scoring system: Area of involvement (A), rated 0 to 6: 0= absent; 1 = <10%; 2 = 10% to 29%; 3 = 30% to 49%; 4= 50% to 69%; 5= 70% to 89%; 6= 90% to 100%. Darkness (D), rated 0 to 4: 0= absent; 1= slight; 2= mild; 3= marked; 4= severe.
mMASI total score = (0,3 x A(F) x D(F) ) + (0,3 x A(LM) x D(LM)) + (0,3 x A(RM) x D(RM)) + (0,1 x A(C) x D(C))
Total mMASI score range: 0 - 24
measure: Colour difference
time frame: week 1, week 7, week 11
description: CIE Lab colour will be measured within the lesion and on the control area outside of the lesion using Cortex Dermalab Combo and colour difference (delta E) will be calculated between the areas and in comparison to baseline values.
Significant change of the melasma colour from baseline and in comparison to control area is expected after 4 Melanostop peel treatments.
measure: Melanin index change
time frame: week 1, week 7, week 11
description: Melanin index will be measured within the lesion and on the control area outside of the lesion using Cortex Dermalab Combo Skin colour probe. Melanin index is given on a scale 0.0-99.9.
Significant change of the melanin index from baseline and in comparison to control area is expected before 4th Melanostop peel treatments and 4 weeks after last treatment.
measure: Area of the melasma
time frame: week 1, week 7, week 11
description: Melasma area will be measured using Visioface photography analysis. Significant change of the melasma area from baseline is expected before 4th Melanostop peel treatments and 4 weeks after last treatment.
arm group label: Melanostop peel treatment group
arm group type: Experimental
description: Adult women aged between 20-50 years old.
Melasma on the face
Fitzpatrick phototypes I-IV
Presenting facial melasma
In good health condition
intervention type: Other
intervention name: Melanostop peel
description: Melanostop peel treatments containing 20% azelaic acid, 10% resorcinol, 6% phytic acid, 3% tranexamic acid. (4 treatments, performed at 2-week intervals), in combination with home care products (twice daily):
a facial tonic and cream containing brightening ingredients: vitamin C, niacinamide, alpha arbutin, kojic acid,
sunscreen protection cream with SPF 50, protecting against UVA, UVB, HEV and IR
arm group label: Melanostop peel treatment group
criteria: 
gender: Female
gender based: Yes
gender description: women
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Katja Žmitek, PhD
role: Study Chair
affiliation: Head of Reasearch Group
facility: 
country: Slovenia
responsible party type: Sponsor
mesh term: Melanosis
sharing ipd: No