Botulinum Toxin to Improve Results in Cleft Lip Repair - Full Text View

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:

MedlinePlus related topics: Botox Cleft Lip and Palate Scars

Drug Information available for: OnabotulinumtoxinA

U.S. FDA Resources

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%

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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

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:

Tollefson TT, Senders CM, Sykes JM, Byorth PJ. Botulinum toxin to improve results in cleft lip repair. Arch Facial Plast Surg. 2006 May-Jun;8(3):221-2. No abstract available.

Gassner HG, Brissett AE, Otley CC, Boahene DK, Boggust AJ, Weaver AL, Sherris DA. Botulinum toxin to improve facial wound healing: A prospective, blinded, placebo-controlled study. Mayo Clin Proc. 2006 Aug;81(8):1023-8.

Gassner HG, Sherris DA, Friedman O. Botulinum toxin-induced immobilization of lower facial wounds. Arch Facial Plast Surg. 2009 Mar-Apr;11(2):140-2. No abstract available.

Gassner HG, Sherris DA, Otley CC. Treatment of facial wounds with botulinum toxin A improves cosmetic outcome in primates. Plast Reconstr Surg. 2000 May;105(6):1948-53; discussion 1954-5.

Larrabee WF Jr. Treatment of Facial Wounds with Botulinum Toxin A Improves Cosmetic Outcome in Primates. Plast Reconstr Surg. 2000 May;105(6):1954-1955. No abstract available.

Lee BJ, Jeong JH, Wang SG, Lee JC, Goh EK, Kim HW. Effect of botulinum toxin type a on a rat surgical wound model. Clin Exp Otorhinolaryngol. 2009 Mar;2(1):20-7. Epub 2009 Mar 26.

Sherris DA, Gassner HG. Botulinum toxin to minimize facial scarring. Facial Plast Surg. 2002 Feb;18(1):35-9.

Wilson AM. Use of botulinum toxin type A to prevent widening of facial scars. Plast Reconstr Surg. 2006 May;117(6):1758-66; discussion 1767-8.

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:

Cleft Lip
Cicatrix
Lip Diseases
Mouth 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 June 17, 2013