<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/NCT03238105</url>
  </required_header>
  <id_info>
    <org_study_id>48653215.5.0000.5327</org_study_id>
    <nct_id>NCT03238105</nct_id>
  </id_info>
  <brief_title>Treatment of Periorbicular Hyperchromia Comparing 10% Thioglycolic Acid Peeling Versus Pulsed Intense Light</brief_title>
  <official_title>Treatment of Periorbicular Hyperchromia Comparing 10% Thioglycolic Acid Peeling Versus Pulsed Intense Light: a Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</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>
      Periorbital hyperchromia (POH) or periorbital hyperpigmentation, commonly known as &quot;dark&#xD;
      circles&quot;, is a relatively common condition and a frequent reason for dermatological&#xD;
      consultation. It is defined as brown-colored pigmentation, ranging from light to dark, which&#xD;
      mainly involves the lower eyelids. POH affects individuals over a wide age range, including&#xD;
      both sexes and all ethnicities, and is associated with a tired and aged facial appearance.&#xD;
      The most commonly affected people are those with the highest skin phototypes. Although the&#xD;
      prevalence is similar between sexes and age groups, POH is a more frequent complaint in&#xD;
      women. The dark circles characteristic of POH can negatively impact patients' quality of&#xD;
      life, although it is not a condition associated with morbidity. Despite its high prevalence,&#xD;
      only a few well-designed studies were done to evaluate its therapeutic options. The intense&#xD;
      pulsed light (IPL) and the thioglycolic acid are safe treatment options and promote the&#xD;
      improvement of dark circles, but it is not known if one treatment differs from the other in&#xD;
      relation to efficacy and adverse effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is a blinded randomized clinical trial, with the sample size calculated of 29 subjects,&#xD;
      already considering 10% of possible losses and refusals. For this number was considered 80%&#xD;
      power and significance level of 5%.&#xD;
&#xD;
      Selected patients will be invited to participate and informed about the characteristics of&#xD;
      the study. If they do, they must sign a free and informed consent form.&#xD;
&#xD;
      At the first visit, some demographic data will be collected, including sex, age, phototype,&#xD;
      history of smoking and / or alcohol consumption, family history of periocular&#xD;
      hyperpigmentation, personal or family history of allergies and hours of sleep, for&#xD;
      instance.Photographic registration will be done in a standardized way. After completion of&#xD;
      the study, the photographs will be evaluated blindly by two evaluators, and they will not&#xD;
      know before what therapeutic modality was adopted in each periorbital region. Clinical&#xD;
      evaluation will be obtained through the application of the Global Aesthetic Improvement Scale&#xD;
      (with the following grades: much better, better, better, no change, worse) and visual&#xD;
      analogue scale for clinical improvement from 0 (no improvement) to 10 (complete improvement),&#xD;
      both with monthly evaluations. Each patient will be submitted to the two proposed therapies,&#xD;
      being a therapeutic procedure in the right periocular region and another in the left&#xD;
      periocular region. Each periocular region will be randomized using the random.org program for&#xD;
      treatment with 10% thioglycolic acid peeling or IPL. Both therapies will be performed at the&#xD;
      same time in the monthly visits, totaling 3 months of treatment (3 sessions of IPL and 3&#xD;
      sessions of thioglycolic acid). The first visit will be for collection of demographic data,&#xD;
      physical examination record, colorimetry and questionnaire completion. Visits 2, 3 and 4 will&#xD;
      be for the treatments and the visit in month 5 will be for evaluation of the results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">February 10, 2020</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>Single Group Assignment</intervention_model>
    <intervention_model_description>The selected patients will have each region of periorbital hyperchromia (right and left) randomized to one of the treatments (split face study).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>There will be 2 blinded evaluators who will not know which side of the periorbital hyperchromia (right or left) received which treatment (IPL or peeling of 10% thioglycolic acid). They will do the evaluation through photographs, comparing the photos before the treatments with the photos after 1, 2 and 3 sessions after the treatments, without knowing what therapeutic modality was adopted in each periorbital region.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical response and compare treatment results</measure>
    <time_frame>5 months</time_frame>
    <description>Through photographs the blinded evaluators will classify the difference on each side (right or left) using the Global Aesthetic Improvement (GAIS) scale. The evaluation will be comparing photographs before treatment with photographs after treatment. The data will be compared between the 2 treatments to evaluate if there was difference between them.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Index in Dermatology</measure>
    <time_frame>5 months</time_frame>
    <description>To evaluate the impact of periocular hyperpigmentation on patients' dermatological quality of life before and after treatments.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pittsburgh Sleep Quality Index</measure>
    <time_frame>at 1 day visit 1</time_frame>
    <description>To evaluate the sleep quality on patients with periocular hyperpigmentation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse effects</measure>
    <time_frame>5 months</time_frame>
    <description>To evaluate the immediate, early and late adverse effects related to the proposed treatments through questionnaires after each session and before the next session</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">29</enrollment>
  <condition>Periorbital Disorder</condition>
  <arm_group>
    <arm_group_label>Intense pulsed light</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The application model will be 3 months of treatment with monthly interval between sessions, totaling 3 sessions. The parameters are as follows: frequency 15 J / cm2, pulse duration 15 ms, 1-2 passed as erythema. Eye protection for IPL will be used during all sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Peeling of 10% thioglycolic acid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the first session the acid will be applied for three minutes, and with each new session the duration time with the product will increase in three minutes, so that in the last session the duration of the application will be 9 minutes. For the application of the product will be used flexible cotton rod, sparing the region just below the eyelids of the lower eyelid 0.5cm, therefore, no other measure is necessary for eye protection. After the given time, the substance will be removed with lint with 0.9% saline solution.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Thioglycolic Acid</intervention_name>
    <description>Monthly sessions for 3 months with progressive increase of the duration of contact time of the drug with the skin, 3, 6 and 9 minutes.</description>
    <arm_group_label>Peeling of 10% thioglycolic acid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intense Pulsed Light</intervention_name>
    <description>Monthly sessions for 3 months.</description>
    <arm_group_label>Intense pulsed light</arm_group_label>
    <other_name>IPL</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with periocular hyperchromia diagnosed by clinical examination. The&#xD;
             volunteers included must have a pigmentary component, which may or may not present the&#xD;
             anatomical component, determined through physical examination with the aid of&#xD;
             dermoscopy, to be performed at the inclusion study visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant patients, active collagenase patients, patients using photosensitizing&#xD;
             substances and areas with bacterial or viral infections, patients with scars or&#xD;
             tattoos at the evaluated site, patients undergoing any treatment modality for&#xD;
             periocular hyperpigmentation in the last 3 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juliana C Boza, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Clínicas de Porto Alegre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de Clinicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90035-003</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>February 11, 2020</last_update_submitted>
  <last_update_submitted_qc>February 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dark circles</keyword>
  <keyword>Periorbital hyperchromia</keyword>
  <keyword>Facial aesthetics</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03238105
org study id: 48653215.5.0000.5327
nct id: NCT03238105
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Periorbital hyperchromia (POH) or periorbital hyperpigmentation, commonly known as "dark
      circles", is a relatively common condition and a frequent reason for dermatological
      consultation. It is defined as brown-colored pigmentation, ranging from light to dark, which
      mainly involves the lower eyelids. POH affects individuals over a wide age range, including
      both sexes and all ethnicities, and is associated with a tired and aged facial appearance.
      The most commonly affected people are those with the highest skin phototypes. Although the
      prevalence is similar between sexes and age groups, POH is a more frequent complaint in
      women. The dark circles characteristic of POH can negatively impact patients' quality of
      life, although it is not a condition associated with morbidity. Despite its high prevalence,
      only a few well-designed studies were done to evaluate its therapeutic options. The intense
      pulsed light (IPL) and the thioglycolic acid are safe treatment options and promote the
      improvement of dark circles, but it is not known if one treatment differs from the other in
      relation to efficacy and adverse effects.
It is a blinded randomized clinical trial, with the sample size calculated of 29 subjects,
      already considering 10% of possible losses and refusals. For this number was considered 80%
      power and significance level of 5%.

      Selected patients will be invited to participate and informed about the characteristics of
      the study. If they do, they must sign a free and informed consent form.

      At the first visit, some demographic data will be collected, including sex, age, phototype,
      history of smoking and / or alcohol consumption, family history of periocular
      hyperpigmentation, personal or family history of allergies and hours of sleep, for
      instance.Photographic registration will be done in a standardized way. After completion of
      the study, the photographs will be evaluated blindly by two evaluators, and they will not
      know before what therapeutic modality was adopted in each periorbital region. Clinical
      evaluation will be obtained through the application of the Global Aesthetic Improvement Scale
      (with the following grades: much better, better, better, no change, worse) and visual
      analogue scale for clinical improvement from 0 (no improvement) to 10 (complete improvement),
      both with monthly evaluations. Each patient will be submitted to the two proposed therapies,
      being a therapeutic procedure in the right periocular region and another in the left
      periocular region. Each periocular region will be randomized using the random.org program for
      treatment with 10% thioglycolic acid peeling or IPL. Both therapies will be performed at the
      same time in the monthly visits, totaling 3 months of treatment (3 sessions of IPL and 3
      sessions of thioglycolic acid). The first visit will be for collection of demographic data,
      physical examination record, colorimetry and questionnaire completion. Visits 2, 3 and 4 will
      be for the treatments and the visit in month 5 will be for evaluation of the results.
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: The selected patients will have each region of periorbital hyperchromia (right and left) randomized to one of the treatments (split face study).
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: There will be 2 blinded evaluators who will not know which side of the periorbital hyperchromia (right or left) received which treatment (IPL or peeling of 10% thioglycolic acid). They will do the evaluation through photographs, comparing the photos before the treatments with the photos after 1, 2 and 3 sessions after the treatments, without knowing what therapeutic modality was adopted in each periorbital region.
measure: Clinical response and compare treatment results
time frame: 5 months
description: Through photographs the blinded evaluators will classify the difference on each side (right or left) using the Global Aesthetic Improvement (GAIS) scale. The evaluation will be comparing photographs before treatment with photographs after treatment. The data will be compared between the 2 treatments to evaluate if there was difference between them.
measure: Quality of Life Index in Dermatology
time frame: 5 months
description: To evaluate the impact of periocular hyperpigmentation on patients' dermatological quality of life before and after treatments.
measure: Pittsburgh Sleep Quality Index
time frame: at 1 day visit 1
description: To evaluate the sleep quality on patients with periocular hyperpigmentation.
measure: Adverse effects
time frame: 5 months
description: To evaluate the immediate, early and late adverse effects related to the proposed treatments through questionnaires after each session and before the next session
arm group label: Intense pulsed light
arm group type: Experimental
description: The application model will be 3 months of treatment with monthly interval between sessions, totaling 3 sessions. The parameters are as follows: frequency 15 J / cm2, pulse duration 15 ms, 1-2 passed as erythema. Eye protection for IPL will be used during all sessions.
arm group label: Peeling of 10% thioglycolic acid
arm group type: Experimental
description: In the first session the acid will be applied for three minutes, and with each new session the duration time with the product will increase in three minutes, so that in the last session the duration of the application will be 9 minutes. For the application of the product will be used flexible cotton rod, sparing the region just below the eyelids of the lower eyelid 0.5cm, therefore, no other measure is necessary for eye protection. After the given time, the substance will be removed with lint with 0.9% saline solution.
intervention type: Drug
intervention name: Thioglycolic Acid
description: Monthly sessions for 3 months with progressive increase of the duration of contact time of the drug with the skin, 3, 6 and 9 minutes.
arm group label: Peeling of 10% thioglycolic acid
intervention type: Device
intervention name: Intense Pulsed Light
description: Monthly sessions for 3 months.
arm group label: Intense pulsed light
other name: IPL
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Juliana C Boza, PhD
role: Principal Investigator
affiliation: Hospital de Clínicas de Porto Alegre
facility: 
country: Brazil
responsible party type: Sponsor
sharing ipd: Undecided