<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/NCT03279003</url>
  </required_header>
  <id_info>
    <org_study_id>SENSILED (29BRC16.0179)</org_study_id>
    <nct_id>NCT03279003</nct_id>
  </id_info>
  <brief_title>Study of the Efficacy and Tolerance of Light Therapy in Sensitive Skin</brief_title>
  <acronym>SENSILED</acronym>
  <official_title>Study of the Efficacy and Tolerance of Light Therapy by Light-emitting Diode (LED) in Sensitive Skin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Brest</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>
      Light-emitting diode (LED) light therapy is increasingly used successfully and without&#xD;
      adverse effects in diabetic leg ulcer, chronic low back pain, chronic myofacial pain in the&#xD;
      neck and in several dermatoses such as acne, Psoriasis, alopecia areata and skin&#xD;
      rejuvenation. A Korean study conducted in 2013 suggested its effectiveness in patients with&#xD;
      sensitive skin in connection with rosacea, acne, eczema. The objective of the study is to&#xD;
      perform a study in subjects with a sensitive skin without associated dermatosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of the study is to evaluate the efficacy of light-emitting diode therapy in&#xD;
      subjects with sensitive skin and to assess pain improvement, evaluation of improvement in&#xD;
      pruritus and evaluation of treatment tolerance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 22, 2018</start_date>
  <completion_date type="Actual">November 12, 2018</completion_date>
  <primary_completion_date type="Actual">November 12, 2018</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of light therapy</measure>
    <time_frame>2 months</time_frame>
    <description>The improvement of sensitive skin symptoms will be measured by the Sensiscale scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of pain improvement</measure>
    <time_frame>2 months</time_frame>
    <description>Pain improvement will be done by self-evaluation of the patients, using a visual analog scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of improvement in pruritus</measure>
    <time_frame>2 months</time_frame>
    <description>The improvement of pruritus will be done by self-evaluation of the patients, using a visual analog scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the tolerance</measure>
    <time_frame>2 months</time_frame>
    <description>At the end of the study, patients will be questioned about the possible occurrence of side effects listed in the patient's notebook during the 8 weeks of treatment.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Sensitive Skin</condition>
  <arm_group>
    <arm_group_label>Light-emitting diode therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exposure to LED light</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LED light</intervention_name>
    <description>An exposure to LED light will be carried out twice a week until improvement, maximum 8 weeks.</description>
    <arm_group_label>Light-emitting diode therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than or equal to 18 years&#xD;
&#xD;
          -  Age less than or equal to 70&#xD;
&#xD;
          -  Sensitive skin defined by a score ≥ 40 on the Sensiscale scale&#xD;
&#xD;
          -  Patient able to consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persons under 18 years of age or over.&#xD;
&#xD;
          -  Persons suffering from disorders of higher functions preventing comprehension of the&#xD;
             questionnaire.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Analgesic or medication acting on the nervous system.&#xD;
&#xD;
          -  Other dermatosis of the face (example: rosacea, seborrheic dermatitis, acne ...).&#xD;
&#xD;
          -  Neurological or psychiatric illness.&#xD;
&#xD;
          -  A photosensitizing drug.&#xD;
&#xD;
          -  Refusal of patient&#xD;
&#xD;
          -  Patients under legal protection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHRU de Brest</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>December 10, 2021</last_update_submitted>
  <last_update_submitted_qc>December 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2021</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>Hypersensitivity</mesh_term>
  </condition_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/NCT03279003
org study id: SENSILED (29BRC16.0179)
nct id: NCT03279003
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Light-emitting diode (LED) light therapy is increasingly used successfully and without
      adverse effects in diabetic leg ulcer, chronic low back pain, chronic myofacial pain in the
      neck and in several dermatoses such as acne, Psoriasis, alopecia areata and skin
      rejuvenation. A Korean study conducted in 2013 suggested its effectiveness in patients with
      sensitive skin in connection with rosacea, acne, eczema. The objective of the study is to
      perform a study in subjects with a sensitive skin without associated dermatosis.
The objective of the study is to evaluate the efficacy of light-emitting diode therapy in
      subjects with sensitive skin and to assess pain improvement, evaluation of improvement in
      pruritus and evaluation of treatment tolerance.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Efficacy of light therapy
time frame: 2 months
description: The improvement of sensitive skin symptoms will be measured by the Sensiscale scale
measure: Assessment of pain improvement
time frame: 2 months
description: Pain improvement will be done by self-evaluation of the patients, using a visual analog scale
measure: Assessment of improvement in pruritus
time frame: 2 months
description: The improvement of pruritus will be done by self-evaluation of the patients, using a visual analog scale
measure: Assessment of the tolerance
time frame: 2 months
description: At the end of the study, patients will be questioned about the possible occurrence of side effects listed in the patient's notebook during the 8 weeks of treatment.
arm group label: Light-emitting diode therapy
arm group type: Experimental
description: Exposure to LED light
intervention type: Device
intervention name: LED light
description: An exposure to LED light will be carried out twice a week until improvement, maximum 8 weeks.
arm group label: Light-emitting diode therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Hypersensitivity