Trial record 18 of 398 for:    Open Studies | "Mouth Diseases"

Botulinum Toxin to Improve Results in Cleft Lip Repair

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Chang Gung Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01429402
First received: September 4, 2011
Last updated: September 6, 2011
Last verified: August 2011
  Purpose

Botulinum toxin type A (Botox; Allergan, Inc., Irvine, Calif) is widely used for facial rejuvenation and many other medical indications. It induces chemodenervation through its action on the presynaptic neuron, preventing release of acetylcholine, which leads to functional denervation of striated muscle for 2 to 6 months after injection. The use of botulinum toxin injection to reduce the facial scar is logical because this could reduce the tensile distracting force of the upper lip caused by the orbicularis oris muscle pull. Tollefson has demonstrate that botulinum toxin injection has decrease lip tension after primary lip repair in 3 children at 3-6 months of age The main aim of this randomized trial is to compare whether post-operative peri-surgical-injection of botulinum toxin into bilateral orbicularis oris muscles can improve scar formation for both primary and secondary cleft lip surgery.


Condition Intervention Phase
Scar
Drug: Botulinum Toxin Type A
Drug: Botulinum Type A
Drug: Normal Saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Botulinum Toxin to Improve Results in Cleft Lip Repair

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Vancouver Scar scale [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    Vancouver scar scale measures pigmentation, vascularity, pliability and scar height on the postoperative 6 month F/U.


Secondary Outcome Measures:
  • Ultrasonography scar measurement [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    On the 6th mo follow up, ultrasonography to measure the scar width will be performed.

  • Photographic measurement [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    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 lip before taken the photo. Then the scar width could be measured.


Estimated Enrollment: 120
Study Start Date: July 2000
Estimated Study Completion Date: August 2013
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: study group I
For primary lip surgery, immediately after primary lip repair will received botulinum toxin injection (1-2U/kg, at 25U/mL) into the bilateral aberrant oriented orbicularis ocuris muscle via 4 superficial injection site
Drug: Botulinum Toxin Type A
1-2U/kg, at 25U/mL, into the bilateral aberrant oriented orbicularis ocuris muscle via 4 superficial injection site; only once after surgery. No additional injection is needed
Other Name: Botox ( Allergan, Inc., Irvine, Calif)
Experimental: Study Group II
For revision lip surgery, immediately after revision lip surgery 3 injection of 2.5U of botulinum toxin with a distance of 0.5 cm from each injection and operative wound are injected over both sides of upper lip in a adult on the operation room.
Drug: Botulinum Type A
b. Study group II: For revision lip surgery, immediately after revision lip surgery 3 injection of 2.5U of botulinum toxin with a distance of 0.5 cm from each injection and operative wound are injected over both sides of upper lip in a adult on the operation room just after surgery. (total dosage injected 15U)
Other Name: Botox ( Allergan, Inc., Irvine, Calif)
Placebo Comparator: Control Group I
Similar amount as group I (in C.C.) of normal saline will be injected after primary lip surgery at 3 months of age.
Drug: Normal Saline
Similar amount (in C.C.) of normal saline as group I will be injected after primary lip surgery at 3 months of age.
Other Name: NaCl 0.9%
Placebo Comparator: Control II
Similar amount (in C.C.) as Study Group II of normal saline will be injected after revision lip surgery (secondary cleft lip repair).
Drug: Normal Saline
Similar amount (in C.C.) of normal saline as study group II will be injected after revision lip surgery (secondary cleft lip repair).
Other Name: NaCl 0.9%

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Months to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion criteria for the primary lip repair group

  • Baby born with cleft lip who will receive primary lip repair at 3 months of age
  • Written informed consent given by parent/guardian.

Inclusion criteria for the secondary lip repair group

  • Adult > 16 years old.
  • Moderate to severe secondary cleft lip and/or nose deformity that warrants corrective surgery.
  • Written informed consent given by parent/guardian/patient.

Exclusion Criteria:

  • Those patient not fit inclusion criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01429402

Locations
Taiwan
Chun Shin Chang Recruiting
Taoyuan, Taiwan, 333
Contact: Chun-Shin Chang, M.D.    886-3-3281200 ext 2340    frankchang@adm.cgmh.org.tw   
Principal Investigator: Chun-Shin Chang, M.D.         
Principal Investigator: Philip Kuo Ting Chen, M.D.         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Chun-Shin Chang, M.D. Chang Gung Memorial Hospital
Principal Investigator: Philip Kuo-Ting Chen, M.D. Chang Gung Memorial Hospital
  More Information

Publications:
Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01429402     History of Changes
Other Study ID Numbers: 98-2237C
Study First Received: September 4, 2011
Last Updated: September 6, 2011
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
Botulinum toxin A.
Cleft lip scar

Additional relevant MeSH terms:
Mouth Diseases
Cleft Lip
Cicatrix
Lip Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities
Fibrosis
Pathologic Processes
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014