Status:
UNKNOWN
Botulinum Toxin to Improve Results in Cleft Lip Repair
Lead Sponsor:
Chang Gung Memorial Hospital
Conditions:
Scar
Eligibility:
All Genders
3-45 years
Phase:
PHASE3
Brief 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 presynapt...
Detailed Description
This is a randomized controlled trial primarily designed to compare the scarring after primary and secondary cleft lip repair using post-operative botulinum toxin injection. There will be 4 main group...
Eligibility Criteria
Inclusion
- 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
- Those patient not fit inclusion criteria
Key Trial Info
Start Date :
July 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2013
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01429402
Start Date
July 1 2000
End Date
August 1 2013
Last Update
September 7 2011
Active Locations (1)
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1
Chun Shin Chang
Taoyuan District, Taoyuan, Taiwan, 333