<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/NCT03294382</url>
  </required_header>
  <id_info>
    <org_study_id>9hospital</org_study_id>
    <nct_id>NCT03294382</nct_id>
  </id_info>
  <brief_title>Botulinum Toxin to Improve Results in Epicanthoplasty</brief_title>
  <official_title>Botulinum Toxin to Improve Results in Epicanthoplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Jiao Tong University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Medial epicanthal fold is a common skin fold in the inner part of the eye in more than 50%&#xD;
      Asia population, giving the illusion of a shorter palpebral fissure length and a wider&#xD;
      intercanthal distance. Currently, various epicanthoplasty techniques have been well described&#xD;
      to correct epicanthus fold. However, hypertrophic scarring after epicanthoplasty remains a&#xD;
      clinical challenge, which seems inevitable and may leading to unpleasing supratarsal crease,&#xD;
      recurrence of medial epicanthus fold, even obvious scar formation. Botulinum toxin type A&#xD;
      (BTX-A) is widely used for facial rejuvenation and many other medical indications. It is a&#xD;
      potent neurotoxin that indirectly blocks neuromuscular transmission and leads to functional&#xD;
      denervation of striated muscle for 2 to 6 months after injection. Recently, experimental&#xD;
      study and clinical trails have revealed that BTX-A can inhibit the growth of fibroblasts&#xD;
      derived from hypertrophic scars and influenced the expression of transforming growth&#xD;
      factor-β1. Therefore, we hypothesized that BTX-A can improve hypertrophic scarring after&#xD;
      epicanthoplasty through release orbicularis oculi muscle tension, inhibit fibroblast growth,&#xD;
      and reduce collagen production. The main aim of this trail is to evaluate the efficiency of&#xD;
      BTX-A injection on improving hypertrophic scaring after epicanthoplasty.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Anticipated">April 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2018</primary_completion_date>
  <phase>Phase 3</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vancouver Scar scale</measure>
    <time_frame>6 month</time_frame>
    <description>Vancouver scar scale measures pigmentation, vascularity, pliability and scar height on the postoperative 6 month F/U</description>
  </primary_outcome>
  <primary_outcome>
    <measure>intercanthal distance ratio</measure>
    <time_frame>6 month</time_frame>
    <description>the ratio of the intercanthal distance to the interpupillary distance</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Photographic measurement</measure>
    <time_frame>6 month</time_frame>
    <description>The scar width of the patient's picture at 6 month after surgery will be measured using photoshop CS3 extended. One ruler will be placed on the patient's nose before taken the photo. Then the scar width could be measured.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">42</enrollment>
  <condition>Scar</condition>
  <condition>Intercanthal Distance Ratio</condition>
  <arm_group>
    <arm_group_label>Botulinum toxin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5U Botulinum toxin in 0.1 mL normal saline, administered in one of the intercanthus</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>0.1 mL normal saline, administered in the other intercanthus</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Botulinum toxin type A</intervention_name>
    <description>5U botulinum toxin in 0.1 mL normal saline, injected in two points at one side, 2.5U per point, local injection</description>
    <arm_group_label>Botulinum toxin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>0.1 mL normal saline, injected in two points at one side, 0.05 mL per point, local injection</description>
    <arm_group_label>Normal Saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with moderate to severe congenital epicanthus.&#xD;
&#xD;
          -  patients accept Park Z epicanthoplasty.&#xD;
&#xD;
          -  Written informed consent given&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  epicanthus caused by trauma, surgical injury.&#xD;
&#xD;
          -  patients with both epicanthus and blepharopotosis.&#xD;
&#xD;
          -  patients with blepharophimosis-ptosis-epicanthus inversus syndrome, or only inversus&#xD;
             epicanthus&#xD;
&#xD;
          -  patients underwent Botulinum Toxin Type A periocular injection within 6 months&#xD;
&#xD;
          -  patients ever have been allergic to Botulinum Toxin Type A or any components of&#xD;
             Botulinum Toxin Type A&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ru-Lin Huang</name>
      <address>
        <city>Shanghai</city>
        <zip>200011</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ru-Lin Huang, Ph.D., M.D.</last_name>
      <phone>86-15821950669</phone>
      <email>hrl222@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Chia-Kang Ho, M.D.</last_name>
      <phone>86-13817381588</phone>
      <email>610542307@qq.com</email>
    </contact_backup>
    <investigator>
      <last_name>Tao Zan, Ph.D., M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ru-Lin Huang, Ph.D., M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Chang CS, Wallace CG, Hsiao YC, Chang CJ, Chen PK. Botulinum toxin to improve results in cleft lip repair: a double-blinded, randomized, vehicle-controlled clinical trial. PLoS One. 2014 Dec 26;9(12):e115690. doi: 10.1371/journal.pone.0115690. eCollection 2014.</citation>
    <PMID>25541942</PMID>
  </reference>
  <reference>
    <citation>Chang CS, Wallace CG, Hsiao YC, Chang CJ, Chen PK. Botulinum toxin to improve results in cleft lip repair. Plast Reconstr Surg. 2014 Sep;134(3):511-516. doi: 10.1097/PRS.0000000000000416.</citation>
    <PMID>25158709</PMID>
  </reference>
  <reference>
    <citation>Al-Qattan MM, Al-Shanawani BN, Alshomer F. Botulinum toxin type A: implications in wound healing, facial cutaneous scarring, and cleft lip repair. Ann Saudi Med. 2013 Sep-Oct;33(5):482-8. doi: 10.5144/0256-4947.2013.482.</citation>
    <PMID>24188943</PMID>
  </reference>
  <reference>
    <citation>Zelken J, Yang SY, Chang CS, Chang CJ, Yang JY, Chuang SS, Chen HC, Hsiao YC. Donor Site Aesthetic Enhancement With Preoperative Botulinum Toxin in Forehead Flap Nasal Reconstruction. Ann Plast Surg. 2016 Nov;77(5):535-538. doi: 10.1097/SAP.0000000000000625.</citation>
    <PMID>26418784</PMID>
  </reference>
  <reference>
    <citation>Kim YS, Lee HJ, Cho SH, Lee JD, Kim HS. Early postoperative treatment of thyroidectomy scars using botulinum toxin: a split-scar, double-blind randomized controlled trial. Wound Repair Regen. 2014 Sep-Oct;22(5):605-12. doi: 10.1111/wrr.12204. Epub 2014 Aug 26.</citation>
    <PMID>24898579</PMID>
  </reference>
  <results_reference>
    <citation>Kwon B, Nguyen AH. Reconsideration of the Epicanthus: Evolution of the Eyelid and the Devolutional Concept of Asian Blepharoplasty. Semin Plast Surg. 2015 Aug;29(3):171-83. doi: 10.1055/s-0035-1556849.</citation>
    <PMID>26306084</PMID>
  </results_reference>
  <results_reference>
    <citation>Elhefnawy AM. Assessment of intralesional injection of botulinum toxin type A injection for hypertrophic scars. Indian J Dermatol Venereol Leprol. 2016 May-Jun;82(3):279-83. doi: 10.4103/0378-6323.173586.</citation>
    <PMID>27088929</PMID>
  </results_reference>
  <results_reference>
    <citation>Shaarawy E, Hegazy RA, Abdel Hay RM. Intralesional botulinum toxin type A equally effective and better tolerated than intralesional steroid in the treatment of keloids: a randomized controlled trial. J Cosmet Dermatol. 2015 Jun;14(2):161-6. doi: 10.1111/jocd.12134. Epub 2015 Mar 24.</citation>
    <PMID>25810045</PMID>
  </results_reference>
  <results_reference>
    <citation>Robinson AJ, Khadim MF, Khan K. Keloid scars and treatment with Botulinum Toxin Type A: the Belfast experience. J Plast Reconstr Aesthet Surg. 2013 Mar;66(3):439-40. doi: 10.1016/j.bjps.2012.08.042. Epub 2012 Oct 23. No abstract available.</citation>
    <PMID>23092904</PMID>
  </results_reference>
  <results_reference>
    <citation>Zhang DZ, Liu XY, Xiao WL, Xu YX. Botulinum Toxin Type A and the Prevention of Hypertrophic Scars on the Maxillofacial Area and Neck: A Meta-Analysis of Randomized Controlled Trials. PLoS One. 2016 Mar 17;11(3):e0151627. doi: 10.1371/journal.pone.0151627. eCollection 2016.</citation>
    <PMID>26985661</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>September 22, 2017</last_update_submitted>
  <last_update_submitted_qc>September 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Jiao Tong University School of Medicine</investigator_affiliation>
    <investigator_full_name>Ru-Lin Huang</investigator_full_name>
    <investigator_title>Ph.D., M.D.</investigator_title>
  </responsible_party>
  <keyword>epicanthoplasty</keyword>
  <keyword>Botulinum Toxins</keyword>
  <keyword>scar</keyword>
  <keyword>intercanthal distance</keyword>
  <keyword>blepharoplasty</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Botulinum Toxins</mesh_term>
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
    <mesh_term>abobotulinumtoxinA</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>October 23, 2017</submitted>
    <submission_canceled>Unknown</submission_canceled>
    <submitted>October 25, 2017</submitted>
    <submission_canceled>Unknown</submission_canceled>
    <submitted>October 29, 2017</submitted>
    <submission_canceled>Unknown</submission_canceled>
    <submitted>January 24, 2018</submitted>
    <returned>September 21, 2018</returned>
  </pending_results>
  <!-- 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/NCT03294382
org study id: 9hospital
nct id: NCT03294382
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Medial epicanthal fold is a common skin fold in the inner part of the eye in more than 50%
      Asia population, giving the illusion of a shorter palpebral fissure length and a wider
      intercanthal distance. Currently, various epicanthoplasty techniques have been well described
      to correct epicanthus fold. However, hypertrophic scarring after epicanthoplasty remains a
      clinical challenge, which seems inevitable and may leading to unpleasing supratarsal crease,
      recurrence of medial epicanthus fold, even obvious scar formation. Botulinum toxin type A
      (BTX-A) is widely used for facial rejuvenation and many other medical indications. It is a
      potent neurotoxin that indirectly blocks neuromuscular transmission and leads to functional
      denervation of striated muscle for 2 to 6 months after injection. Recently, experimental
      study and clinical trails have revealed that BTX-A can inhibit the growth of fibroblasts
      derived from hypertrophic scars and influenced the expression of transforming growth
      factor-β1. Therefore, we hypothesized that BTX-A can improve hypertrophic scarring after
      epicanthoplasty through release orbicularis oculi muscle tension, inhibit fibroblast growth,
      and reduce collagen production. The main aim of this trail is to evaluate the efficiency of
      BTX-A injection on improving hypertrophic scaring after epicanthoplasty.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Vancouver Scar scale
time frame: 6 month
description: Vancouver scar scale measures pigmentation, vascularity, pliability and scar height on the postoperative 6 month F/U
measure: intercanthal distance ratio
time frame: 6 month
description: the ratio of the intercanthal distance to the interpupillary distance
measure: Photographic measurement
time frame: 6 month
description: The scar width of the patient's picture at 6 month after surgery will be measured using photoshop CS3 extended. One ruler will be placed on the patient's nose before taken the photo. Then the scar width could be measured.
arm group label: Botulinum toxin
arm group type: Experimental
description: 5U Botulinum toxin in 0.1 mL normal saline, administered in one of the intercanthus
arm group label: Normal Saline
arm group type: Placebo Comparator
description: 0.1 mL normal saline, administered in the other intercanthus
intervention type: Drug
intervention name: Botulinum toxin type A
description: 5U botulinum toxin in 0.1 mL normal saline, injected in two points at one side, 2.5U per point, local injection
arm group label: Botulinum toxin
intervention type: Drug
intervention name: Placebo
description: 0.1 mL normal saline, injected in two points at one side, 0.05 mL per point, local injection
arm group label: Normal Saline
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: China
citation: Chang CS, Wallace CG, Hsiao YC, Chang CJ, Chen PK. Botulinum toxin to improve results in cleft lip repair: a double-blinded, randomized, vehicle-controlled clinical trial. PLoS One. 2014 Dec 26;9(12):e115690. doi: 10.1371/journal.pone.0115690. eCollection 2014.
PMID: 25541942
citation: Chang CS, Wallace CG, Hsiao YC, Chang CJ, Chen PK. Botulinum toxin to improve results in cleft lip repair. Plast Reconstr Surg. 2014 Sep;134(3):511-516. doi: 10.1097/PRS.0000000000000416.
PMID: 25158709
citation: Al-Qattan MM, Al-Shanawani BN, Alshomer F. Botulinum toxin type A: implications in wound healing, facial cutaneous scarring, and cleft lip repair. Ann Saudi Med. 2013 Sep-Oct;33(5):482-8. doi: 10.5144/0256-4947.2013.482.
PMID: 24188943
citation: Zelken J, Yang SY, Chang CS, Chang CJ, Yang JY, Chuang SS, Chen HC, Hsiao YC. Donor Site Aesthetic Enhancement With Preoperative Botulinum Toxin in Forehead Flap Nasal Reconstruction. Ann Plast Surg. 2016 Nov;77(5):535-538. doi: 10.1097/SAP.0000000000000625.
PMID: 26418784
citation: Kim YS, Lee HJ, Cho SH, Lee JD, Kim HS. Early postoperative treatment of thyroidectomy scars using botulinum toxin: a split-scar, double-blind randomized controlled trial. Wound Repair Regen. 2014 Sep-Oct;22(5):605-12. doi: 10.1111/wrr.12204. Epub 2014 Aug 26.
PMID: 24898579
citation: Kwon B, Nguyen AH. Reconsideration of the Epicanthus: Evolution of the Eyelid and the Devolutional Concept of Asian Blepharoplasty. Semin Plast Surg. 2015 Aug;29(3):171-83. doi: 10.1055/s-0035-1556849.
PMID: 26306084
citation: Elhefnawy AM. Assessment of intralesional injection of botulinum toxin type A injection for hypertrophic scars. Indian J Dermatol Venereol Leprol. 2016 May-Jun;82(3):279-83. doi: 10.4103/0378-6323.173586.
PMID: 27088929
citation: Shaarawy E, Hegazy RA, Abdel Hay RM. Intralesional botulinum toxin type A equally effective and better tolerated than intralesional steroid in the treatment of keloids: a randomized controlled trial. J Cosmet Dermatol. 2015 Jun;14(2):161-6. doi: 10.1111/jocd.12134. Epub 2015 Mar 24.
PMID: 25810045
citation: Robinson AJ, Khadim MF, Khan K. Keloid scars and treatment with Botulinum Toxin Type A: the Belfast experience. J Plast Reconstr Aesthet Surg. 2013 Mar;66(3):439-40. doi: 10.1016/j.bjps.2012.08.042. Epub 2012 Oct 23. No abstract available.
PMID: 23092904
citation: Zhang DZ, Liu XY, Xiao WL, Xu YX. Botulinum Toxin Type A and the Prevention of Hypertrophic Scars on the Maxillofacial Area and Neck: A Meta-Analysis of Randomized Controlled Trials. PLoS One. 2016 Mar 17;11(3):e0151627. doi: 10.1371/journal.pone.0151627. eCollection 2016.
PMID: 26985661
responsible party type: Principal Investigator
investigator affiliation: Shanghai Jiao Tong University School of Medicine
investigator full name: Ru-Lin Huang
investigator title: Ph.D., M.D.
mesh term: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA
sharing ipd: No
submitted: October 23, 2017
submission canceled: Unknown
submitted: October 25, 2017
submission canceled: Unknown
submitted: October 29, 2017
submission canceled: Unknown
submitted: January 24, 2018
returned: September 21, 2018