Botulinum Toxin to Improve Results in Cleft Lip Repair

• Status: Unknown status
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chang Gung Memorial Hospital
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

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