Botulinum Toxin to Improve Results in Cleft Lip Repair

NCT01429402 | Unknown Phase 3 DMC

• 1 other identifier: 98-2237C
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Scar

Keywords

Botulinum toxin A.; Cleft lip scar

Outcome Measures

Primary Outcomes (1)

• Vancouver Scar scale

  Vancouver scar scale measures pigmentation, vascularity, pliability and scar height on the postoperative 6 month F/U.

  6 month

Secondary Outcomes (2)

• Ultrasonography scar measurement

  6 month

• Photographic measurement

  6 month

Study Arms (4)

study group I

EXPERIMENTAL

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

Study Group II

EXPERIMENTAL

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

Control Group I

PLACEBO COMPARATOR

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

Control II

PLACEBO COMPARATOR

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

Interventions

Botulinum Toxin Type A DRUG

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

Also known as: Botox ( Allergan, Inc., Irvine, Calif)

study group I

Botulinum Type A DRUG

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)

Also known as: Botox ( Allergan, Inc., Irvine, Calif)

Study Group II

Normal Saline DRUG

Similar amount (in C.C.) of normal saline as group I will be injected after primary lip surgery at 3 months of age.

Also known as: NaCl 0.9%

Control Group I

Eligibility Criteria

• Age: 3 Months - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chun Shin Chang

Taoyuan District, Taoyuan, 333, Taiwan

RECRUITING

Related Publications (10)

• 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. doi: 10.1001/archfaci.8.3.221. No abstract available.

  PMID: 16702537 BACKGROUND

• 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. doi: 10.4065/81.8.1023.

  PMID: 16901024 BACKGROUND

• 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. doi: 10.1001/archfacial.2009.3. No abstract available.

  PMID: 19289689 BACKGROUND

• 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. doi: 10.1097/00006534-200005000-00005.

  PMID: 10839391 BACKGROUND

• 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. doi: 10.1097/00006534-200005000-00006. No abstract available.

  PMID: 11242330 BACKGROUND

• 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. doi: 10.3342/ceo.2009.2.1.20. Epub 2009 Mar 26.

  PMID: 19434287 BACKGROUND

• Sherris DA, Gassner HG. Botulinum toxin to minimize facial scarring. Facial Plast Surg. 2002 Feb;18(1):35-9. doi: 10.1055/s-2002-19825.

  PMID: 11823931 BACKGROUND

• 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. doi: 10.1097/01.prs.0000209944.45949.d1.

  PMID: 16651948 BACKGROUND

• Chang CS, Wallace CG, Hsiao YC, Chang CJ, Chen PK. Botulinum toxin to improve results in cleft lip repair: a double-blinded, randomized, vehicle-controlled clinical trial. PLoS One. 2014 Dec 26;9(12):e115690. doi: 10.1371/journal.pone.0115690. eCollection 2014.

  PMID: 25541942 DERIVED

• Chang CS, Wallace CG, Hsiao YC, Chang CJ, Chen PK. Botulinum toxin to improve results in cleft lip repair. Plast Reconstr Surg. 2014 Sep;134(3):511-516. doi: 10.1097/PRS.0000000000000416.

  PMID: 25158709 DERIVED

MeSH Terms

Conditions

Cicatrix

Interventions

Botulinum Toxins, Type A; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Chun-Shin Chang, M.D.

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Philip Kuo-Ting Chen, M.D.

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2011
• First Posted: September 7, 2011
• Study Start: July 1, 2000
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2013
• Last Updated: September 7, 2011

Record last verified: 2011-08

Locations

TW (1)