<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/NCT03767400</url>
  </required_header>
  <id_info>
    <org_study_id>SCRIC18-OCT-01</org_study_id>
    <nct_id>NCT03767400</nct_id>
  </id_info>
  <brief_title>Dynamic Optical Coherence Tomography(D-OCT) Aging Study: A Preliminary Evaluation of Structural Differences Between Young and Aged Skin, Cellulite and Atrophic Acne Scars in Female Caucasian Subjects With Fitzpatrick Skin Types I-III Utilizing Non-invasive in Vivo D-OCT.</brief_title>
  <official_title>Dynamic Optical Coherence Tomography (D-OCT) Aging Study: A Preliminary Evaluation of Structural Differences Between Young and Aged Skin, Cellulite and Atrophic Acne Scars in Female Caucasian Subjects With Fitzpatrick Skin Types I-III Utilizing Non-invasive in Vivo D-OCT.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allergan</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Allergan</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>
      This single-center clinical study is being conducted over the course of 2 weeks to conduct an&#xD;
      exploratory pilot study as a preliminary evaluation of D-OCT's ability to measure skin&#xD;
      changes from aging. Assess structural differences between young and aged skin on the face. To&#xD;
      identify the structural characteristics of atrophic acne scars relative to normal skin on the&#xD;
      face. To explore characteristics of cellulite relative to normal skin on the thigh in young&#xD;
      and aged skin.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 7, 2018</start_date>
  <completion_date type="Actual">July 30, 2019</completion_date>
  <primary_completion_date type="Actual">May 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>VivoSight software measurements of Epidermal Thickness</measure>
    <time_frame>Day 1</time_frame>
    <description>Epidermal thickness will be measured in microns.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VivoSight software measurements of surface roughness</measure>
    <time_frame>Day 1</time_frame>
    <description>Surface roughness measurements (Ra, Rq, Rz) will be measured in microns.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VivoSight software measurements of redness</measure>
    <time_frame>Day 1</time_frame>
    <description>Redness will be measured in percent</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VivoSight software measurements of attenuation coefficient</measure>
    <time_frame>Day 1</time_frame>
    <description>Attenuation coefficient will be measured in AU (arbitrary unit)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Photodamage Score at Day 1</measure>
    <time_frame>Day 1</time_frame>
    <description>The Investigator will assess the participant's overall photodamage using a 10-point scale where (0) = None to (9) = Severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Appearance of Fine Lines/Wrinkles Cheek Areas</measure>
    <time_frame>Day 1</time_frame>
    <description>The investigator will assess the participant's appearance of fine lines/wrinkles using a 5-point scale from (0=None to 4=Diffuse).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-study Dynamic Optical Coherence Tomography (D-OCT) Image Analysis of Epidermal Thickness</measure>
    <time_frame>Day 1</time_frame>
    <description>Post-study D-OCT image analysis will be done (at the sponsor's discretion) by an independent physician expert.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-study D-OCT Image Analysis of Density and Attenuation Coefficient of Epidermis</measure>
    <time_frame>Day 1</time_frame>
    <description>Post-study D-OCT image analysis will be done (at the sponsor's discretion) by an independent physician expert.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-study D-OCT Image Analysis of Density and Attenuation Coefficient of Superficial Dermis</measure>
    <time_frame>Day 1</time_frame>
    <description>Post-study D-OCT image analysis will be done (at the sponsor's discretion) by an independent physician expert.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-study D-OCT Image Analysis of Collagen Fibers</measure>
    <time_frame>Day 1</time_frame>
    <description>Post-study D-OCT image analysis will be done (at the sponsor's discretion) by an independent physician expert. Measured as normal or in bundles.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-study D-OCT Image Analysis of Integrity of Collagen</measure>
    <time_frame>Day 1</time_frame>
    <description>Post-study D-OCT image analysis will be done (at the sponsor's discretion) by an independent physician expert. Measure as (few, moderate, or many fragments).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-study D-OCT Image Analysis of Score of Vessels</measure>
    <time_frame>Day 1</time_frame>
    <description>Post-study D-OCT image analysis will be done (at the sponsor's discretion) by an independent physician expert. Measured at 300 and 500 microns.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-study D-OCT Image Analysis of Vascularity Quantification with Thresholds</measure>
    <time_frame>Day 1</time_frame>
    <description>Post-study D-OCT image analysis will be done (at the sponsor's discretion) by an independent physician expert. Measured at 300 and 500 microns depth.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blinded Independent Physician Assessor Grading of the D-OCT Images of Stratum Corneum Reflectivity</measure>
    <time_frame>Day 1</time_frame>
    <description>Grading (0 = absent to 3 = high).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blinded Independent Physician Assessor Grading of the D-OCT images of Upper Dermal Reflectivity</measure>
    <time_frame>Day 1</time_frame>
    <description>Grading (0 = absent to 3 = high).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blinded Independent Physician Assessor Grading of the D-OCT Images of Dermoepidermal Contrast</measure>
    <time_frame>Day 1</time_frame>
    <description>Grading (0 = absent to 3 = high).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blinded Independent Physician Assessor Grading of the D-OCT images of Vessel Density</measure>
    <time_frame>Day 1</time_frame>
    <description>Grading (0 = no vessels to 3 = many vessels).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antera 3D Images</measure>
    <time_frame>Day 1</time_frame>
    <description>The investigator will capture 3D images utilizing the Antera 3D.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VISIA-CR Images</measure>
    <time_frame>Day 1</time_frame>
    <description>The investigator will capture standardized digital photographs utilizing the VISIA-CR.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">99</enrollment>
  <condition>Skin Care</condition>
  <arm_group>
    <arm_group_label>Group A - Young skin (18 - 30 years old)</arm_group_label>
    <description>Assessments will be made after facial cleansing on areas being imaged utilizing VivoSight Dynamic Optical Coherence Tomography (D-OCT). Post-study D-OCT images will be processed with VivoSight software. Assessments of participant's overall photodamage and participant's appearance of fine lines/wrinkles will be measured.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B - Aged skin (55 - 75 years old)</arm_group_label>
    <description>Assessments will be made after facial cleansing on areas being imaged utilizing VivoSight Dynamic Optical Coherence Tomography (D-OCT). Post-study D-OCT images will be processed with VivoSight software. Assessments of participant's overall photodamage and participant's appearance of fine lines/wrinkles will be measured.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C - Atrophic acne scars (18 - 75 years old)</arm_group_label>
    <description>Assessments will be made after facial cleansing on areas being imaged utilizing VivoSight Dynamic Optical Coherence Tomography (D-OCT). Post-study D-OCT images will be processed with VivoSight software. Assessments of participant's overall photodamage and participant's appearance of fine lines/wrinkles will be measured.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Skin Imaging</intervention_name>
    <description>Non-invasive in vivo skin imaging will be taken with the VivoSight D-OCT and the measurements will be acquired post-study utilizing VivoSight software.</description>
    <arm_group_label>Group A - Young skin (18 - 30 years old)</arm_group_label>
    <arm_group_label>Group B - Aged skin (55 - 75 years old)</arm_group_label>
    <arm_group_label>Group C - Atrophic acne scars (18 - 75 years old)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Facial Cleanser</intervention_name>
    <description>Participants will be instructed to remove all makeup from the face and cleanse the face with SkinMedica Facial Cleanser at least 15 minutes prior to investigator assessments and photography, and at least 30 minutes prior to use of D-OCT. Particiapnts in the cellulite group will have the thigh area cleansed with Facial Cleanser at least 15 minutes prior to photography and at least 30 minutes prior to use of D-OCT. For standardization, this procedure will be performed with SkinMedica Facial Cleanser (to remove makeup and cleanse the face and thigh (if applicable)) for all the participants.</description>
    <arm_group_label>Group A - Young skin (18 - 30 years old)</arm_group_label>
    <arm_group_label>Group B - Aged skin (55 - 75 years old)</arm_group_label>
    <arm_group_label>Group C - Atrophic acne scars (18 - 75 years old)</arm_group_label>
    <other_name>SkinMedica® Facial Cleanser</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Female Caucasian subjects with Fitzpatrick skin types I-III that meet one of the criteria&#xD;
        listed; ages 18-30 years old without acne scars on the face with or without visible&#xD;
        cellulite on posterior thigh, or ages 55-75 years old without acne scars on the face with&#xD;
        or without visible cellulite on posterior thigh, or ages 18-75 years old with atrophic acne&#xD;
        scars.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female Caucasian subjects with Fitzpatrick skin types I-III that meet one of the&#xD;
             criteria listed below:&#xD;
&#xD;
               1. Ages 18-30 years old without acne scars on the face with or without visible&#xD;
                  cellulite on posterior thigh, or&#xD;
&#xD;
               2. Ages 55-75 years old without acne scars on the face with or without visible&#xD;
                  cellulite on posterior thigh, or&#xD;
&#xD;
               3. Ages 18-75 years old with atrophic acne scars&#xD;
&#xD;
          -  Subject has completed an appropriately administered informed consent process which&#xD;
             includes signing the IRB approved consent form.&#xD;
&#xD;
          -  Good general health and free of any disease state or physical condition (e.g.&#xD;
             psoriasis, rosacea, scars, tattoos etc.) which, in the investigator's opinion, might&#xD;
             impair evaluations of the test sites or expose the subject to an unacceptable risk by&#xD;
             study participation.&#xD;
&#xD;
          -  Willingness to remove all makeup on the day of the visit. Makeup may be applied after&#xD;
             the study visit has been completed.&#xD;
&#xD;
          -  Willingness to cleanse their face and remove all face makeup at each scheduled clinic&#xD;
             visit. No other topical products should be applied to the face until the study visit&#xD;
             has been completed.&#xD;
&#xD;
             i. For cellulite subgroup, willingness to have thigh cleansed at each scheduled clinic&#xD;
             visit.&#xD;
&#xD;
          -  Willingness to have investigator exams, skin instrumentation measurements, and digital&#xD;
             photos performed on the face and/or thigh (for cellulite subgroup).&#xD;
&#xD;
          -  Women of childbearing potential must not be pregnant at the time of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has any condition that, in the opinion of the investigator, would make it unsafe for&#xD;
             the subject to participate in the study or interfere with their clinical assessments&#xD;
             (including conditions that require the concurrent use of anticoagulants, bleeding&#xD;
             coagulopathies, photosensitivity diseases).&#xD;
&#xD;
          -  Individuals with active symptoms of allergy, cold sore or warts, active psoriasis or&#xD;
             eczema, rosacea, sunburn, open wounds, neurotic excoriations, tattoos, or other skin&#xD;
             conditions in the test areas that would interfere with the assessments of this study.&#xD;
&#xD;
          -  Individuals who are pregnant.&#xD;
&#xD;
          -  Uncontrolled disease such as diabetes, hypertension, hyper or hypo-thyroidism, active&#xD;
             hepatitis, immune deficiency, or autoimmune.&#xD;
&#xD;
          -  Individuals who have a pre-existing or dormant dermatologic condition (e.g. history of&#xD;
             severe psoriasis, atopic dermatitis, rosacea, skin cancer, etc.)&#xD;
&#xD;
          -  Individuals who have routinely used any of the following topical products,&#xD;
             prescription products, or had any of the listed treatments/procedures within the&#xD;
             listed time frame prior to study entry or will use during study:&#xD;
&#xD;
               1. Any product that the investigator deems that could affect the study objectives.&#xD;
                  These include products that address skin imperfections. This does not include a&#xD;
                  basic cleanser, moisturizer and sunscreen.(time frame 2 weeks)&#xD;
&#xD;
               2. Chemical peel, microdermabrasion, dermaplaning, or microneedling (time frame 3&#xD;
                  months)&#xD;
&#xD;
               3. Retin-A®, Retin-A Micro®, Renova®, Avita®, Tazorac®, Avage® or Differin® or other&#xD;
                  similar prescription drugs (time frame 3 months)&#xD;
&#xD;
               4. Cosmetic injections (filler and/or toxins, i.e. Juvederm, Radiesse, Botox, etc.),&#xD;
                  non-ablative laser or fractional laser resurfacing (time frame 12 months)&#xD;
&#xD;
               5. Accutane® or other oral retinoid, Ablative procedures (i.e. laser, chemical)&#xD;
                  (time frame 12 months)&#xD;
&#xD;
          -  Individuals who have any planned surgeries or procedures during the study.&#xD;
&#xD;
          -  Individuals who participated in a facial usage study within the last 30 days, or who&#xD;
             are currently participating on another usage study.&#xD;
&#xD;
          -  Individuals currently on or planning to participate on any type of research study at&#xD;
             another facility or a doctor's office during this study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lisa Goberdhan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Allergan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Skinmedica Clinical Research and Innovation Center</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>October 29, 2019</last_update_submitted>
  <last_update_submitted_qc>October 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 31, 2019</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>Cellulite</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/NCT03767400
org study id: SCRIC18-OCT-01
nct id: NCT03767400
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This single-center clinical study is being conducted over the course of 2 weeks to conduct an
      exploratory pilot study as a preliminary evaluation of D-OCT's ability to measure skin
      changes from aging. Assess structural differences between young and aged skin on the face. To
      identify the structural characteristics of atrophic acne scars relative to normal skin on the
      face. To explore characteristics of cellulite relative to normal skin on the thigh in young
      and aged skin.
observational model: Case-Control
time perspective: Prospective
measure: VivoSight software measurements of Epidermal Thickness
time frame: Day 1
description: Epidermal thickness will be measured in microns.
measure: VivoSight software measurements of surface roughness
time frame: Day 1
description: Surface roughness measurements (Ra, Rq, Rz) will be measured in microns.
measure: VivoSight software measurements of redness
time frame: Day 1
description: Redness will be measured in percent
measure: VivoSight software measurements of attenuation coefficient
time frame: Day 1
description: Attenuation coefficient will be measured in AU (arbitrary unit)
measure: Overall Photodamage Score at Day 1
time frame: Day 1
description: The Investigator will assess the participant's overall photodamage using a 10-point scale where (0) = None to (9) = Severe).
measure: Overall Appearance of Fine Lines/Wrinkles Cheek Areas
time frame: Day 1
description: The investigator will assess the participant's appearance of fine lines/wrinkles using a 5-point scale from (0=None to 4=Diffuse).
measure: Post-study Dynamic Optical Coherence Tomography (D-OCT) Image Analysis of Epidermal Thickness
time frame: Day 1
description: Post-study D-OCT image analysis will be done (at the sponsor's discretion) by an independent physician expert.
measure: Post-study D-OCT Image Analysis of Density and Attenuation Coefficient of Epidermis
time frame: Day 1
description: Post-study D-OCT image analysis will be done (at the sponsor's discretion) by an independent physician expert.
measure: Post-study D-OCT Image Analysis of Density and Attenuation Coefficient of Superficial Dermis
time frame: Day 1
description: Post-study D-OCT image analysis will be done (at the sponsor's discretion) by an independent physician expert.
measure: Post-study D-OCT Image Analysis of Collagen Fibers
time frame: Day 1
description: Post-study D-OCT image analysis will be done (at the sponsor's discretion) by an independent physician expert. Measured as normal or in bundles.
measure: Post-study D-OCT Image Analysis of Integrity of Collagen
time frame: Day 1
description: Post-study D-OCT image analysis will be done (at the sponsor's discretion) by an independent physician expert. Measure as (few, moderate, or many fragments).
measure: Post-study D-OCT Image Analysis of Score of Vessels
time frame: Day 1
description: Post-study D-OCT image analysis will be done (at the sponsor's discretion) by an independent physician expert. Measured at 300 and 500 microns.
measure: Post-study D-OCT Image Analysis of Vascularity Quantification with Thresholds
time frame: Day 1
description: Post-study D-OCT image analysis will be done (at the sponsor's discretion) by an independent physician expert. Measured at 300 and 500 microns depth.
measure: Blinded Independent Physician Assessor Grading of the D-OCT Images of Stratum Corneum Reflectivity
time frame: Day 1
description: Grading (0 = absent to 3 = high).
measure: Blinded Independent Physician Assessor Grading of the D-OCT images of Upper Dermal Reflectivity
time frame: Day 1
description: Grading (0 = absent to 3 = high).
measure: Blinded Independent Physician Assessor Grading of the D-OCT Images of Dermoepidermal Contrast
time frame: Day 1
description: Grading (0 = absent to 3 = high).
measure: Blinded Independent Physician Assessor Grading of the D-OCT images of Vessel Density
time frame: Day 1
description: Grading (0 = no vessels to 3 = many vessels).
measure: Antera 3D Images
time frame: Day 1
description: The investigator will capture 3D images utilizing the Antera 3D.
measure: VISIA-CR Images
time frame: Day 1
description: The investigator will capture standardized digital photographs utilizing the VISIA-CR.
arm group label: Group A - Young skin (18 - 30 years old)
description: Assessments will be made after facial cleansing on areas being imaged utilizing VivoSight Dynamic Optical Coherence Tomography (D-OCT). Post-study D-OCT images will be processed with VivoSight software. Assessments of participant's overall photodamage and participant's appearance of fine lines/wrinkles will be measured.
arm group label: Group B - Aged skin (55 - 75 years old)
description: Assessments will be made after facial cleansing on areas being imaged utilizing VivoSight Dynamic Optical Coherence Tomography (D-OCT). Post-study D-OCT images will be processed with VivoSight software. Assessments of participant's overall photodamage and participant's appearance of fine lines/wrinkles will be measured.
arm group label: Group C - Atrophic acne scars (18 - 75 years old)
description: Assessments will be made after facial cleansing on areas being imaged utilizing VivoSight Dynamic Optical Coherence Tomography (D-OCT). Post-study D-OCT images will be processed with VivoSight software. Assessments of participant's overall photodamage and participant's appearance of fine lines/wrinkles will be measured.
intervention type: Device
intervention name: Skin Imaging
description: Non-invasive in vivo skin imaging will be taken with the VivoSight D-OCT and the measurements will be acquired post-study utilizing VivoSight software.
arm group label: Group A - Young skin (18 - 30 years old)
arm group label: Group B - Aged skin (55 - 75 years old)
arm group label: Group C - Atrophic acne scars (18 - 75 years old)
intervention type: Other
intervention name: Facial Cleanser
description: Participants will be instructed to remove all makeup from the face and cleanse the face with SkinMedica Facial Cleanser at least 15 minutes prior to investigator assessments and photography, and at least 30 minutes prior to use of D-OCT. Particiapnts in the cellulite group will have the thigh area cleansed with Facial Cleanser at least 15 minutes prior to photography and at least 30 minutes prior to use of D-OCT. For standardization, this procedure will be performed with SkinMedica Facial Cleanser (to remove makeup and cleanse the face and thigh (if applicable)) for all the participants.
arm group label: Group A - Young skin (18 - 30 years old)
arm group label: Group B - Aged skin (55 - 75 years old)
arm group label: Group C - Atrophic acne scars (18 - 75 years old)
other name: SkinMedica® Facial Cleanser
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lisa Goberdhan
role: Principal Investigator
affiliation: Allergan
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cellulite