<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/NCT03750422</url>
  </required_header>
  <id_info>
    <org_study_id>STRATPHARMA-2018-01</org_study_id>
    <nct_id>NCT03750422</nct_id>
  </id_info>
  <brief_title>Stretch Marks on Abdomen</brief_title>
  <official_title>A Split-body, Double-blinded, Placebo-controlled Trial of Stratacel® Wound Dressing After Laser Treatment of Striae Alba</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Goldman, Butterwick, Fitzpatrick and Groff</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Goldman, Butterwick, Fitzpatrick and Groff</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to determine the effect of Stratacel® wound dressing&#xD;
      on cosmetic outcomes following 1064/532nm picosecond laser (Picoway®, Syneron Candela Corp,&#xD;
      Wayland, MA, USA) treatment of abdominal striae alba. Secondary objectives include examining&#xD;
      the effect of Stratacel® wound dressing on post-laser healing and symptomatology.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Twenty adult subjects with abdominal striae alba will be enrolled. All striae will be treated&#xD;
      using the 1064/532nm picosecond laser with designated and standardized settings (Appendix A).&#xD;
      The abdominal striae treatment region will then be split across the body vertically with one&#xD;
      half randomized to Stratacel® and the other to placebo, clear ultrasound gel (Aquasonic). A&#xD;
      blinded study coordinator will apply the products to each randomized half-abdomen immediately&#xD;
      following laser treatment.&#xD;
&#xD;
      A total of 3 treatments will be completed at 1 month intervals. Blinded-investigator and&#xD;
      subject self-assessments will be performed at post-treatment days 2, 5, 7, and 10 after each&#xD;
      laser session. Assessments will also be performed 1 and 3 months after the final laser&#xD;
      treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">November 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>double-blinded, randomized split-body study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Subjects are provided with de-identified tubes of both study product and vehicle then instructed on which de-identified product is to be used for aftercare on which side of the abdomen.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Striae Texture</measure>
    <time_frame>Pre-Treatment to 3-months post final treatment.</time_frame>
    <description>Assessment of texture Pre treatment and post final treatment using a 5-Point Blinded Investigator Striae Assessment scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Striae Color</measure>
    <time_frame>Pre-Treatment to 3-months post final treatment.</time_frame>
    <description>Assessment of Color Pre treatment and post final treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Striae Size</measure>
    <time_frame>Pre-Treatment to 3-months post final treatment.</time_frame>
    <description>Assessment of Size Pre treatment and post final treatment using a 5-Point Blinded Investigator Striae Assessment scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Striae Overall Appearance</measure>
    <time_frame>Pre-Treatment to 3-months post final treatment.</time_frame>
    <description>Assessment of Overall Appearance Pre treatment and post final treatment using a 6-Point Blinded Investigator Striae Assessment scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety - Post Laser Treatment Adverse Events</measure>
    <time_frame>days 2, 5, 7, and 10 after each laser session</time_frame>
    <description>erythema, edema, crusting, bruising, hyperpigmentation, hypopigmentation, and scarring</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Striae; Albicantes</condition>
  <arm_group>
    <arm_group_label>Stratacel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>medical grade silicone gel following Picoway Laser treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Clear ultrasound gel following Picoway Laser treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Picoway</intervention_name>
    <description>1064/532nm picosecond laser</description>
    <arm_group_label>Stratacel</arm_group_label>
    <arm_group_label>Vehicle</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stratacel</intervention_name>
    <description>a self-drying, bacteriostatic, transparent silicone gel with anti-inflammatory properties</description>
    <arm_group_label>Stratacel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aquasonic</intervention_name>
    <description>clear ultrasound gel</description>
    <arm_group_label>Vehicle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Females or Males in good general health &gt;18 years of age.&#xD;
&#xD;
          2. Must be willing to give and sign a photography release, HIPPA and informed consent.&#xD;
&#xD;
          3. Subject must have at least 2 white striae on each treatment side of the abdomen that&#xD;
             measure at least 1cm in length.&#xD;
&#xD;
          4. Females will be either of non-childbearing potential defined as:&#xD;
&#xD;
        1. Having no uterus 2. No menses for at least 12 months.&#xD;
&#xD;
        Or:&#xD;
&#xD;
        Women of childbearing potential must agree to use an effective method of birth control&#xD;
        during the course of the study. All systemic birth control measures must be in consistent&#xD;
        use for at least 30 days prior to study enrollment participation. Expectable forms of birth&#xD;
        control below:&#xD;
&#xD;
          1. Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device&#xD;
&#xD;
          2. Intrauterine coil&#xD;
&#xD;
          3. Bilateral tubal ligation&#xD;
&#xD;
          4. Barrier method used with an additional form of contraception (e.g., sponge, spermicide&#xD;
             or condom)&#xD;
&#xD;
          5. Abstinence (If practicing abstinence must agree to use barrier method described above&#xD;
             (4) if becomes sexually active).&#xD;
&#xD;
          6. Vasectomized (must agree to use barrier method described above (4) if becomes sexually&#xD;
             active with un-vasectomized partner).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Pregnancy, planned pregnancy during the course of the study or currently breast feeding.&#xD;
&#xD;
        2. Projected significant fluctuations in weight during the course of the study or within&#xD;
        the last 6 months, per investigator discretion.&#xD;
&#xD;
          1. Recent use of self-tanners, excessive exposure to sunlight, artificial UV light (e.g.:&#xD;
             use of tanning beds/booths and/or sunbathing) or expectations of tanning and/or use of&#xD;
             self-tanners during the course of the study.&#xD;
&#xD;
          2. Any planned surgical or cosmetic procedure in the treatment area during the course of&#xD;
             the study.&#xD;
&#xD;
          3. Any UNCONTROLLED systemic disease -a potential patient in whom therapy for a systemic&#xD;
             disease is not yet stabilized will not be considered for entry into the study.&#xD;
&#xD;
          4. Significant history or current evidence of a medical, psychological or other disorder&#xD;
             that, in the investigator's opinion, would preclude enrollment into the study.&#xD;
&#xD;
          5. Red or brown colored striae in the intended treatment area.&#xD;
&#xD;
          6. Active dermatitis, open wound, active bacterial, neurologic, fungal, or viral&#xD;
             infection in the proposed treatment area.&#xD;
&#xD;
          7. Inability to ambulate following the procedure.&#xD;
&#xD;
          8. History of skin tightening or other treatment in the striae region in the preceding 12&#xD;
             months before study enrollment and for duration of the study.&#xD;
&#xD;
          9. Use of topical retinoids, hydroquinone, medicated cleansers, cellulite creams, or&#xD;
             steroids to the treatment area within the preceding 2 weeks and for duration of the&#xD;
             study.&#xD;
&#xD;
         10. Allergy to any ingredient in the study medication or placebo.&#xD;
&#xD;
         11. Current participation or participation within 30 days prior to the start of this study&#xD;
             in a drug or other investigational research study.&#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>Mitchel P Goldman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cosmetic Laser Dermatology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>West Dermatology Research Center</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>November 8, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>May 8, 2019</last_update_submitted>
  <last_update_submitted_qc>May 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Goldman, Butterwick, Fitzpatrick and Groff</investigator_affiliation>
    <investigator_full_name>Isabella Guiha</investigator_full_name>
    <investigator_title>CCRC</investigator_title>
  </responsible_party>
  <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/NCT03750422
org study id: STRATPHARMA-2018-01
nct id: NCT03750422
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The primary objective of this study is to determine the effect of Stratacel® wound dressing
      on cosmetic outcomes following 1064/532nm picosecond laser (Picoway®, Syneron Candela Corp,
      Wayland, MA, USA) treatment of abdominal striae alba. Secondary objectives include examining
      the effect of Stratacel® wound dressing on post-laser healing and symptomatology.
Twenty adult subjects with abdominal striae alba will be enrolled. All striae will be treated
      using the 1064/532nm picosecond laser with designated and standardized settings (Appendix A).
      The abdominal striae treatment region will then be split across the body vertically with one
      half randomized to Stratacel® and the other to placebo, clear ultrasound gel (Aquasonic). A
      blinded study coordinator will apply the products to each randomized half-abdomen immediately
      following laser treatment.

      A total of 3 treatments will be completed at 1 month intervals. Blinded-investigator and
      subject self-assessments will be performed at post-treatment days 2, 5, 7, and 10 after each
      laser session. Assessments will also be performed 1 and 3 months after the final laser
      treatment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: double-blinded, randomized split-body study
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Subjects are provided with de-identified tubes of both study product and vehicle then instructed on which de-identified product is to be used for aftercare on which side of the abdomen.
measure: Change in Striae Texture
time frame: Pre-Treatment to 3-months post final treatment.
description: Assessment of texture Pre treatment and post final treatment using a 5-Point Blinded Investigator Striae Assessment scale
measure: Change in Striae Color
time frame: Pre-Treatment to 3-months post final treatment.
description: Assessment of Color Pre treatment and post final treatment
measure: Change in Striae Size
time frame: Pre-Treatment to 3-months post final treatment.
description: Assessment of Size Pre treatment and post final treatment using a 5-Point Blinded Investigator Striae Assessment scale.
measure: Change in Striae Overall Appearance
time frame: Pre-Treatment to 3-months post final treatment.
description: Assessment of Overall Appearance Pre treatment and post final treatment using a 6-Point Blinded Investigator Striae Assessment scale
measure: Safety - Post Laser Treatment Adverse Events
time frame: days 2, 5, 7, and 10 after each laser session
description: erythema, edema, crusting, bruising, hyperpigmentation, hypopigmentation, and scarring
arm group label: Stratacel
arm group type: Active Comparator
description: medical grade silicone gel following Picoway Laser treatment
arm group label: Vehicle
arm group type: Sham Comparator
description: Clear ultrasound gel following Picoway Laser treatment
intervention type: Device
intervention name: Picoway
description: 1064/532nm picosecond laser
arm group label: Stratacel
arm group label: Vehicle
intervention type: Other
intervention name: Stratacel
description: a self-drying, bacteriostatic, transparent silicone gel with anti-inflammatory properties
arm group label: Stratacel
intervention type: Other
intervention name: Aquasonic
description: clear ultrasound gel
arm group label: Vehicle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mitchel P Goldman, MD
role: Principal Investigator
affiliation: Cosmetic Laser Dermatology
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Goldman, Butterwick, Fitzpatrick and Groff
investigator full name: Isabella Guiha
investigator title: CCRC
sharing ipd: No