<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/NCT04417348</url>
  </required_header>
  <id_info>
    <org_study_id>OPN3Mel</org_study_id>
    <nct_id>NCT04417348</nct_id>
  </id_info>
  <brief_title>Opsin Receptors in Melasma</brief_title>
  <official_title>Expression of Opsins Receptors in Melasma and Its Modification With UV-Visible Light Sunscreen and 0.05% Retinoic Acid.</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Melasma is a hyperpigmentation disorder that is probably exacerbated by visible light. Opsin&#xD;
      receptors (OPN 1, 2, 3, 4 y 5) were described in the skin, being capable of activating&#xD;
      melanogenesis induced by visible light. The aim of this study was to evaluate the expression&#xD;
      of OPN in melasma skin and its changes following treatment with UV-Vis filter and 0.05%&#xD;
      retinoic acid for 12 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2019</start_date>
  <completion_date type="Actual">December 15, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 2019</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>
    <intervention_model_description>patients with melasma divided in a UV-Visible light filter with 0.05% retinoic acid group and UV-Visible light filter alone</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MASI score</measure>
    <time_frame>3 months</time_frame>
    <description>Melasma Activity and Severity Index</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Opsin receptors</measure>
    <time_frame>3 months</time_frame>
    <description>Relative Expression of the opsin receptors by RT-qPCR</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Melasma</condition>
  <arm_group>
    <arm_group_label>Retinoic Acid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients with melasma treated with 0.05% retinoic acid plus UV-Visible light filter</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sunscreen</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>patients with melasma treated with UV-Visible light filter alone</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Retinoic acid</intervention_name>
    <description>To evaluate the role of Opsin receptors in melasma. The patients were treated with 0.05% Retinoic Acid, a regular therapy to treatment melasma, a ligand of Opsin receptors. Also, Uv-Visible light filter treatment as a posible opsin receptor blocker</description>
    <arm_group_label>Retinoic Acid</arm_group_label>
    <arm_group_label>Sunscreen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with melasma, of 18 years of age and older, without previous&#xD;
             treatment or photoprotection measures within the previous 4 weeks, who had Melasma&#xD;
             Activity and Severity Index (MASI) scores higher than 7&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy or nursing, menopause, coexistence of other pigmentation conditions, heat&#xD;
             exposure, regular exercise, diet restriction, consumption of food supplements or any&#xD;
             type of drugs (including anti-inflammatories and hormonal treatments) within the&#xD;
             previous 2 months, and women who had given birth within 1 year&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dermatology Department. Hospital Central &quot;Dr. Ignacio Morones Prieto&quot;</name>
      <address>
        <city>San Luis Potosí</city>
        <zip>78290</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <results_reference>
    <citation>Regazzetti C, Sormani L, Debayle D, Bernerd F, Tulic MK, De Donatis GM, Chignon-Sicard B, Rocchi S, Passeron T. Melanocytes Sense Blue Light and Regulate Pigmentation through Opsin-3. J Invest Dermatol. 2018 Jan;138(1):171-178. doi: 10.1016/j.jid.2017.07.833. Epub 2017 Aug 24.</citation>
    <PMID>28842328</PMID>
  </results_reference>
  <results_reference>
    <citation>Ozdeslik RN, Olinski LE, Trieu MM, Oprian DD, Oancea E. Human nonvisual opsin 3 regulates pigmentation of epidermal melanocytes through functional interaction with melanocortin 1 receptor. Proc Natl Acad Sci U S A. 2019 Jun 4;116(23):11508-11517. doi: 10.1073/pnas.1902825116. Epub 2019 May 16.</citation>
    <PMID>31097585</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</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>Adjunt professor</investigator_title>
  </responsible_party>
  <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>Tretinoin</mesh_term>
  </intervention_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/NCT04417348
org study id: OPN3Mel
nct id: NCT04417348
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Melasma is a hyperpigmentation disorder that is probably exacerbated by visible light. Opsin
      receptors (OPN 1, 2, 3, 4 y 5) were described in the skin, being capable of activating
      melanogenesis induced by visible light. The aim of this study was to evaluate the expression
      of OPN in melasma skin and its changes following treatment with UV-Vis filter and 0.05%
      retinoic acid for 12 weeks.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: patients with melasma divided in a UV-Visible light filter with 0.05% retinoic acid group and UV-Visible light filter alone
primary purpose: Basic Science
masking: None (Open Label)
measure: MASI score
time frame: 3 months
description: Melasma Activity and Severity Index
measure: Opsin receptors
time frame: 3 months
description: Relative Expression of the opsin receptors by RT-qPCR
arm group label: Retinoic Acid
arm group type: Active Comparator
description: patients with melasma treated with 0.05% retinoic acid plus UV-Visible light filter
arm group label: Sunscreen
arm group type: Placebo Comparator
description: patients with melasma treated with UV-Visible light filter alone
intervention type: Drug
intervention name: Retinoic acid
description: To evaluate the role of Opsin receptors in melasma. The patients were treated with 0.05% Retinoic Acid, a regular therapy to treatment melasma, a ligand of Opsin receptors. Also, Uv-Visible light filter treatment as a posible opsin receptor blocker
arm group label: Retinoic Acid
arm group label: Sunscreen
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Mexico
citation: Regazzetti C, Sormani L, Debayle D, Bernerd F, Tulic MK, De Donatis GM, Chignon-Sicard B, Rocchi S, Passeron T. Melanocytes Sense Blue Light and Regulate Pigmentation through Opsin-3. J Invest Dermatol. 2018 Jan;138(1):171-178. doi: 10.1016/j.jid.2017.07.833. Epub 2017 Aug 24.
PMID: 28842328
citation: Ozdeslik RN, Olinski LE, Trieu MM, Oprian DD, Oancea E. Human nonvisual opsin 3 regulates pigmentation of epidermal melanocytes through functional interaction with melanocortin 1 receptor. Proc Natl Acad Sci U S A. 2019 Jun 4;116(23):11508-11517. doi: 10.1073/pnas.1902825116. Epub 2019 May 16.
PMID: 31097585
responsible party type: Principal Investigator
investigator affiliation: Universidad Autonoma de San Luis Potosí
investigator full name: Juan Pablo Castanedo-Cazares
investigator title: Adjunt professor
mesh term: Melanosis
mesh term: Tretinoin
sharing ipd: No