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Improvement of the Appearance of Cleft Lip Scars Using Botox

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ClinicalTrials.gov Identifier: NCT02247193
Recruitment Status : Recruiting
First Posted : September 23, 2014
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Jeffrey D. Johnson, The University of Texas Health Science Center, Houston

Brief Summary:

Objectives: To determine if the use of botulinum toxin during primary cleft lip repair improves the cosmetic appearance of the scar

Study Design: Double blinded randomized controlled trial

Methods: Study to be completed at an academic tertiary hospital. Patients must be 6 months of age or younger with a unrepaired complete unilateral cleft lip and palate requiring a primary cheiloplasty. Botulinum toxin will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair. Control subjects will receive a placebo injection in place of the toxin. Surgeons will be blinded to patients that receive the experimental injection. Outcomes will be determined using 3D-videography preoperatively and post operatively at scheduled visits with a total of one year follow up. A scar assessment questionnaire will be completed by parents at select post operative visits. Videography images will also be assessed by a blinded expert panel at the completion of the study.


Condition or disease Intervention/treatment Phase
Cleft Lip Scarring Cleft Palate Drug: Botulinum Toxin Type A Drug: Normal Saline Injection Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Botulinum Toxin to Improve Cosmesis of Primary Cleft Lip Repair
Actual Study Start Date : December 2015
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Botulinum Toxin
Injection of botulinum toxin into cleft lip at time of surgical repair.
Drug: Botulinum Toxin Type A
Injection of toxin at the time of surgery at cleft lip repair site

Placebo Comparator: Saline
Injection of normal saline into cleft lip at time of surgical repair.
Drug: Normal Saline Injection
Injection of normal saline into cleft lip at time of surgical repair.




Primary Outcome Measures :
  1. Modified Vancouver Scar Scale - Expert Panel Analysis [ Time Frame: 2 years ]
    Videography will be sent to an expert panel of select plastic surgeons that will also use the Modified Vancouver Scar Scale to assess scar outcomes in both the control and experimental groups. This panel will be blinded to which patients received botulinum toxin and which received the control injection.


Secondary Outcome Measures :
  1. Modified Vancouver Scar Scale - Parental Assessment [ Time Frame: 2 years ]
    Parents at select visits will be asked to use the Modified Vancouver Scar Scale to assess scar outcomes of their child. Again parents will be blinded to whether their child received the experimental injection.


Other Outcome Measures:
  1. Videography assessment suing the aesthetic grading scale [ Time Frame: 2 years ]
    Videography at the completion of the study will also be assessed for the following measures which are part of the aesthetic grading scale: Matching accuracy of white roll and vermilion border, scar appearance, Cupid's bow form, length of lip, nostril symmetry, alar dome form, and alar base position. Study personnel will be blinded to which patients received the experimental injection.



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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Unilateral cleft lip with or without cleft palate, less than 6 months of age

Exclusion Criteria:

Bilateral cleft lip, older than 6 months of age


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247193


Contacts
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Contact: Jaecel O Shah, MD jaecel.o.shah@uth.tmc.edu
Contact: John F Teichgraeber, MD 713.500.7285 John.F.Teichgraeber@uth.tmc.edu

Locations
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United States, Texas
Memorial Hermann Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Carol Underwood, BSN/RN    713-704-4230      
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Jaecel O Shah, MD UTHealth

Publications of Results:

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Responsible Party: Jeffrey D. Johnson, Resident, PGY-3, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02247193     History of Changes
Other Study ID Numbers: HSC-MS-14-0335
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Keywords provided by Jeffrey D. Johnson, The University of Texas Health Science Center, Houston:
Botulinum Toxin
Botox
Craniofacial deformity
Additional relevant MeSH terms:
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Cleft Palate
Cleft Lip
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents