<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/NCT01695356</url>
  </required_header>
  <id_info>
    <org_study_id>VISUV-melasma</org_study_id>
    <nct_id>NCT01695356</nct_id>
  </id_info>
  <brief_title>Ultraviolet and UV-Visible Light Photoprotection for the Treatment of Melasma</brief_title>
  <official_title>A Double Blind Randomized Study Comparing the Ultraviolet (UV) Photoprotection With UV Plus Visible Light Photoprotection in the Treatment of Melasma.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Autonoma de San Luis Potosí</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Central &quot;Dr. Ignacio Morones Prieto&quot;</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidad Autonoma de San Luis Potosí</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Melasma is an acquired discoloration of the skin characterized by brown colour changes&#xD;
      commonly on the face. The duration of this double-blind clinical trial will be 12 weeks. The&#xD;
      control group will receive treatment with topical Hydroquinone (4%) and a Broad spectrum UV&#xD;
      sunscreen. The experimental group, 4% topical hydroquinone and a Broad spectrum UV-visible&#xD;
      light sunscreen. Visible light has melanotic properties and avoiding it can be part of the&#xD;
      treatment for melasma patients. The estimated number of subjects to be recruited and&#xD;
      randomized for the study is at least 25 per group. The purpose of this study is determine if&#xD;
      there is a difference in the improvement between these two sunscreens types. Melasma Area and&#xD;
      Severity Index (MASI) score will be assessed at the beginning of the study and at weeks 4, 8,&#xD;
      and 12. Photographs, colorimetry and histological assessment will be also evaluated.&#xD;
      Occurrence of adverse effects will also be recorded.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Melasma is a common acquired hypermelanosis in dark skin populations, usually characterized&#xD;
      by symmetrical, irregular macules occurring in photo-exposed areas such as face. Treatment&#xD;
      with sunscreens and depigmenting compounds such as hydroquinone, are still the gold standard&#xD;
      in this condition.&#xD;
&#xD;
      Visible light has pigmenting properties that could be interfering with the treatment in&#xD;
      melasma patients. So, the primary objective of this study is to compare the depigmenting&#xD;
      adjuvant effect of using a UV-visible blocking sunscreen against a UV sunscreen.&#xD;
&#xD;
      Patients who are included in the study will be randomly assigned to receive one of the&#xD;
      sunscreen type, which should use for 12 weeks. The sun blocking agents should be applied in&#xD;
      the affected regions every 3 hours from 8AM to 5PM. The evaluation of clinical improvement&#xD;
      will be done in a blinded modality by means of the MASI score, the Global Physician&#xD;
      Assessment, as well as colorimetry and histological melanin content. Evaluations will be held&#xD;
      on visits at 4, 8 and 12 weeks. Skin biopsy will be taken at onset and at 12 weeks.&#xD;
&#xD;
      At the end of the study, data will be compared concerning the former parameters. All side&#xD;
      effects will be recorded and analysed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</primary_completion_date>
  <phase>Phase 4</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Depigmentation of melasma lesions by Colorimetry</measure>
    <time_frame>12 weeks</time_frame>
    <description>Quantification of the colour change in the melasma lesions by means of the L axis of the CIE system. 0 value is pure white, 100 value is total black.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MASI (Melasma Area Severity Index)</measure>
    <time_frame>12 weeks</time_frame>
    <description>It is a clinical instrument of melasma measurement. The total score would range from 0-24, involving the forehead (30%), right malar (30%), left malar (30%) and chin (10%), and using area of involvement (0=absent, 1=&lt;10%, 2=10%-29%, 3=30%-49%, 4=50%-69%, 5=70%-89% and 6=90%-100%) and darkness (0=absent, 1=slight, 2=mild, 3=marked and 4=severe). Computation would be as follows: 0.3 A(f) D(f) + 0.3 A(lm) D(lm) + 0.3 A(rm) D(rm) + 0.1 A(c) D(c).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Melanin content by histologic quantification.</measure>
    <time_frame>12 weeks</time_frame>
    <description>The Fontana-Masson Stain is specific for melanin, this histochemical reaction reveals accumulations of black material wherever melanin is located. A skin biopsy of lesions will be taken initially and at the end of study. The melanin content will be quantified by a software image analysis of the slides.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Physician Assessment</measure>
    <time_frame>12 weeks</time_frame>
    <description>Clinical improvement is assessed by means of digital photographic registration (frontal, right, and left views). An independent observer clinically graded the global improvement as poor (0-25%), mild (26-50%), good (51-75%), and excellent (&gt;75%).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Melasma</condition>
  <arm_group>
    <arm_group_label>290-400 nm sunscreen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sunscreen containing Mexoryl SX, Mexoryl XL, Titanium Dioxide, Octocrylene, Tinosorb S, Avobenzone, and Ethylhexyl triazone.&#xD;
Fluid vehicle administered daily, from 8AM to 5PM every 3 hr, for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>290-800 nm sunscreen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sunscreen containing Benzophenone-3, Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide, and iron oxide.&#xD;
Fluid vehicle administered daily, from 8AM to 5PM every 3 hr, for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>290-400 nm sunscreen</intervention_name>
    <description>A broad UV spectrum sunscreen will be applied every 3 hours for 12 weeks. The affected surface will be covered with a 2 mg/cm^2 layer of the product as indicated on the affected areas of the face.</description>
    <arm_group_label>290-400 nm sunscreen</arm_group_label>
    <other_name>Octocrylene</other_name>
    <other_name>Titanium dioxide</other_name>
    <other_name>Butyl methoxydibenzoylmethane</other_name>
    <other_name>Bis-ethylhexyloxyphenol methoxyphenyl triazine</other_name>
    <other_name>Drometrizole trisiloxane</other_name>
    <other_name>Ethylhexyl triazone</other_name>
    <other_name>Terephthalylidene dicamphor sulfonic acid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>290-800 nm sunscreen</intervention_name>
    <description>A UV-visible light spectrum sunscreen will be applied every 3 hours for 12 weeks. The affected surface will be covered with a 2 mg/cm^2 layer of the product as indicated on the affected areas of the face.</description>
    <arm_group_label>290-800 nm sunscreen</arm_group_label>
    <other_name>Benzophenone-3</other_name>
    <other_name>Octinoxate</other_name>
    <other_name>Octocrylene</other_name>
    <other_name>Titanium Dioxide</other_name>
    <other_name>Zinc Oxide</other_name>
    <other_name>Iron oxide</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  Women over 25 years of age&#xD;
&#xD;
          -  Dermatologic diagnostic of melasma&#xD;
&#xD;
          -  Phototype III or more&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
&#xD;
          -  Postbirth, abortion in the past 6 months&#xD;
&#xD;
          -  Having an endocrine or autoimmune disease&#xD;
&#xD;
          -  Under hormonal therapy of any kind including contraceptives or it´s use in the past 6&#xD;
             months&#xD;
&#xD;
          -  Currently under treatment for melasma including sunscreens&#xD;
&#xD;
          -  Currently under radiation therapy, chemotherapy, immunosuppressants of any kind or&#xD;
             phototherapy or it´s use in the past 6 months&#xD;
&#xD;
          -  Having used or are consuming photosensitizing substances, oral or topical&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Diana Hernandez-Blanco, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Central &quot;Dr. Ignacio Morones Prieto&quot;</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Juan P Castanedo-Cazares, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Central &quot;Dr. Ignacio Morones Prieto&quot;</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bertha Torres-Alvarez, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Central &quot;Dr. Ignacio Morones Prieto&quot;</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dermatology Department. Hospital Central &quot;Dr. Ignacio Morones Prieto&quot;</name>
      <address>
        <city>San Luis Potosi</city>
        <zip>78210</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <reference>
    <citation>Navarrete-Solis J, Castanedo-Cazares JP, Torres-Alvarez B, Oros-Ovalle C, Fuentes-Ahumada C, Gonzalez FJ, Martinez-Ramirez JD, Moncada B. A Double-Blind, Randomized Clinical Trial of Niacinamide 4% versus Hydroquinone 4% in the Treatment of Melasma. Dermatol Res Pract. 2011;2011:379173. doi: 10.1155/2011/379173. Epub 2011 Jul 21.</citation>
    <PMID>21822427</PMID>
  </reference>
  <reference>
    <citation>Torres-Alvarez B, Mesa-Garza IG, Castanedo-Cazares JP, Fuentes-Ahumada C, Oros-Ovalle C, Navarrete-Solis J, Moncada B. Histochemical and immunohistochemical study in melasma: evidence of damage in the basal membrane. Am J Dermatopathol. 2011 May;33(3):291-5. doi: 10.1097/DAD.0b013e3181ef2d45.</citation>
    <PMID>21317614</PMID>
  </reference>
  <reference>
    <citation>Moncada B, Sahagun-Sanchez LK, Torres-Alvarez B, Castanedo-Cazares JP, Martinez-Ramirez JD, Gonzalez FJ. Molecular structure and concentration of melanin in the stratum corneum of patients with melasma. Photodermatol Photoimmunol Photomed. 2009 Jun;25(3):159-60. doi: 10.1111/j.1600-0781.2009.00425.x.</citation>
    <PMID>19438997</PMID>
  </reference>
  <reference>
    <citation>Hernandez-Barrera R, Torres-Alvarez B, Castanedo-Cazares JP, Oros-Ovalle C, Moncada B. Solar elastosis and presence of mast cells as key features in the pathogenesis of melasma. Clin Exp Dermatol. 2008 May;33(3):305-8. doi: 10.1111/j.1365-2230.2008.02724.x.</citation>
    <PMID>18419607</PMID>
  </reference>
  <reference>
    <citation>Espinal-Perez LE, Moncada B, Castanedo-Cazares JP. A double-blind randomized trial of 5% ascorbic acid vs. 4% hydroquinone in melasma. Int J Dermatol. 2004 Aug;43(8):604-7. doi: 10.1111/j.1365-4632.2004.02134.x.</citation>
    <PMID>15304189</PMID>
  </reference>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>December 1, 2014</last_update_submitted>
  <last_update_submitted_qc>December 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Autonoma de San Luis Potosí</investigator_affiliation>
    <investigator_full_name>Juan Pablo Castanedo-Cazares</investigator_full_name>
    <investigator_title>Dermatology assistant professor</investigator_title>
  </responsible_party>
  <keyword>Melasma</keyword>
  <keyword>sunscreens</keyword>
  <keyword>visible light</keyword>
  <keyword>ultraviolet light</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sunscreening Agents</mesh_term>
    <mesh_term>Zinc Oxide</mesh_term>
    <mesh_term>Titanium dioxide</mesh_term>
    <mesh_term>Avobenzone</mesh_term>
    <mesh_term>Terephthalylidene dicamphor sulfonic acid</mesh_term>
    <mesh_term>Benzophenone</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01695356
org study id: VISUV-melasma
nct id: NCT01695356
lead sponsor: 
collaborator: 
has dmc: No
Melasma is an acquired discoloration of the skin characterized by brown colour changes
      commonly on the face. The duration of this double-blind clinical trial will be 12 weeks. The
      control group will receive treatment with topical Hydroquinone (4%) and a Broad spectrum UV
      sunscreen. The experimental group, 4% topical hydroquinone and a Broad spectrum UV-visible
      light sunscreen. Visible light has melanotic properties and avoiding it can be part of the
      treatment for melasma patients. The estimated number of subjects to be recruited and
      randomized for the study is at least 25 per group. The purpose of this study is determine if
      there is a difference in the improvement between these two sunscreens types. Melasma Area and
      Severity Index (MASI) score will be assessed at the beginning of the study and at weeks 4, 8,
      and 12. Photographs, colorimetry and histological assessment will be also evaluated.
      Occurrence of adverse effects will also be recorded.
Melasma is a common acquired hypermelanosis in dark skin populations, usually characterized
      by symmetrical, irregular macules occurring in photo-exposed areas such as face. Treatment
      with sunscreens and depigmenting compounds such as hydroquinone, are still the gold standard
      in this condition.

      Visible light has pigmenting properties that could be interfering with the treatment in
      melasma patients. So, the primary objective of this study is to compare the depigmenting
      adjuvant effect of using a UV-visible blocking sunscreen against a UV sunscreen.

      Patients who are included in the study will be randomly assigned to receive one of the
      sunscreen type, which should use for 12 weeks. The sun blocking agents should be applied in
      the affected regions every 3 hours from 8AM to 5PM. The evaluation of clinical improvement
      will be done in a blinded modality by means of the MASI score, the Global Physician
      Assessment, as well as colorimetry and histological melanin content. Evaluations will be held
      on visits at 4, 8 and 12 weeks. Skin biopsy will be taken at onset and at 12 weeks.

      At the end of the study, data will be compared concerning the former parameters. All side
      effects will be recorded and analysed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Depigmentation of melasma lesions by Colorimetry
time frame: 12 weeks
description: Quantification of the colour change in the melasma lesions by means of the L axis of the CIE system. 0 value is pure white, 100 value is total black.
measure: MASI (Melasma Area Severity Index)
time frame: 12 weeks
description: It is a clinical instrument of melasma measurement. The total score would range from 0-24, involving the forehead (30%), right malar (30%), left malar (30%) and chin (10%), and using area of involvement (0=absent, 1=<10%, 2=10%-29%, 3=30%-49%, 4=50%-69%, 5=70%-89% and 6=90%-100%) and darkness (0=absent, 1=slight, 2=mild, 3=marked and 4=severe). Computation would be as follows: 0.3 A(f) D(f) + 0.3 A(lm) D(lm) + 0.3 A(rm) D(rm) + 0.1 A(c) D(c).
measure: Melanin content by histologic quantification.
time frame: 12 weeks
description: The Fontana-Masson Stain is specific for melanin, this histochemical reaction reveals accumulations of black material wherever melanin is located. A skin biopsy of lesions will be taken initially and at the end of study. The melanin content will be quantified by a software image analysis of the slides.
measure: Global Physician Assessment
time frame: 12 weeks
description: Clinical improvement is assessed by means of digital photographic registration (frontal, right, and left views). An independent observer clinically graded the global improvement as poor (0-25%), mild (26-50%), good (51-75%), and excellent (>75%).
arm group label: 290-400 nm sunscreen
arm group type: Active Comparator
description: Sunscreen containing Mexoryl SX, Mexoryl XL, Titanium Dioxide, Octocrylene, Tinosorb S, Avobenzone, and Ethylhexyl triazone.
Fluid vehicle administered daily, from 8AM to 5PM every 3 hr, for 12 weeks.
arm group label: 290-800 nm sunscreen
arm group type: Experimental
description: Sunscreen containing Benzophenone-3, Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide, and iron oxide.
Fluid vehicle administered daily, from 8AM to 5PM every 3 hr, for 12 weeks.
intervention type: Drug
intervention name: 290-400 nm sunscreen
description: A broad UV spectrum sunscreen will be applied every 3 hours for 12 weeks. The affected surface will be covered with a 2 mg/cm^2 layer of the product as indicated on the affected areas of the face.
arm group label: 290-400 nm sunscreen
other name: Octocrylene
other name: Titanium dioxide
other name: Butyl methoxydibenzoylmethane
other name: Bis-ethylhexyloxyphenol methoxyphenyl triazine
other name: Drometrizole trisiloxane
other name: Ethylhexyl triazone
other name: Terephthalylidene dicamphor sulfonic acid
intervention type: Drug
intervention name: 290-800 nm sunscreen
description: A UV-visible light spectrum sunscreen will be applied every 3 hours for 12 weeks. The affected surface will be covered with a 2 mg/cm^2 layer of the product as indicated on the affected areas of the face.
arm group label: 290-800 nm sunscreen
other name: Benzophenone-3
other name: Octinoxate
other name: Octocrylene
other name: Titanium Dioxide
other name: Zinc Oxide
other name: Iron oxide
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 60 Years
healthy volunteers: No
last name: Diana Hernandez-Blanco, MD
role: Principal Investigator
affiliation: Hospital Central "Dr. Ignacio Morones Prieto"
last name: Juan P Castanedo-Cazares, MD
role: Study Director
affiliation: Hospital Central "Dr. Ignacio Morones Prieto"
last name: Bertha Torres-Alvarez, MD
role: Study Chair
affiliation: Hospital Central "Dr. Ignacio Morones Prieto"
facility: 
country: Mexico
citation: Navarrete-Solis J, Castanedo-Cazares JP, Torres-Alvarez B, Oros-Ovalle C, Fuentes-Ahumada C, Gonzalez FJ, Martinez-Ramirez JD, Moncada B. A Double-Blind, Randomized Clinical Trial of Niacinamide 4% versus Hydroquinone 4% in the Treatment of Melasma. Dermatol Res Pract. 2011;2011:379173. doi: 10.1155/2011/379173. Epub 2011 Jul 21.
PMID: 21822427
citation: Torres-Alvarez B, Mesa-Garza IG, Castanedo-Cazares JP, Fuentes-Ahumada C, Oros-Ovalle C, Navarrete-Solis J, Moncada B. Histochemical and immunohistochemical study in melasma: evidence of damage in the basal membrane. Am J Dermatopathol. 2011 May;33(3):291-5. doi: 10.1097/DAD.0b013e3181ef2d45.
PMID: 21317614
citation: Moncada B, Sahagun-Sanchez LK, Torres-Alvarez B, Castanedo-Cazares JP, Martinez-Ramirez JD, Gonzalez FJ. Molecular structure and concentration of melanin in the stratum corneum of patients with melasma. Photodermatol Photoimmunol Photomed. 2009 Jun;25(3):159-60. doi: 10.1111/j.1600-0781.2009.00425.x.
PMID: 19438997
citation: Hernandez-Barrera R, Torres-Alvarez B, Castanedo-Cazares JP, Oros-Ovalle C, Moncada B. Solar elastosis and presence of mast cells as key features in the pathogenesis of melasma. Clin Exp Dermatol. 2008 May;33(3):305-8. doi: 10.1111/j.1365-2230.2008.02724.x.
PMID: 18419607
citation: Espinal-Perez LE, Moncada B, Castanedo-Cazares JP. A double-blind randomized trial of 5% ascorbic acid vs. 4% hydroquinone in melasma. Int J Dermatol. 2004 Aug;43(8):604-7. doi: 10.1111/j.1365-4632.2004.02134.x.
PMID: 15304189
responsible party type: Principal Investigator
investigator affiliation: Universidad Autonoma de San Luis Potosí
investigator full name: Juan Pablo Castanedo-Cazares
investigator title: Dermatology assistant professor
mesh term: Melanosis
mesh term: Sunscreening Agents
mesh term: Zinc Oxide
mesh term: Titanium dioxide
mesh term: Avobenzone
mesh term: Terephthalylidene dicamphor sulfonic acid
mesh term: Benzophenone