Botulinum Toxin to Improve Cosmesis of Primary Cleft Lip Repair

NCT02247193 | Completed Phase 1 Results FDA Drug

• 1 other identifier: HSC-MS-14-0335
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To determine if the use of botulinum toxin during primary cleft lip repair improves the cosmetic appearance of the cleft lip scar

Conditions

Cleft Lip; Scarring; Cleft Palate

Keywords

Botulinum Toxin; Botox; Craniofacial deformity

Outcome Measures

Primary Outcomes (8)

• Hypertrophic Scarring (HTS) as Assessed by Score on the Manchester Scar Scale (MSS) Rated by Blinded Plastic Surgeons

  The Manchester Scar Scale (MSS) assesses color match to surrounding skin, skin texture, contour, and distortion, and total MSS score ranges from 4 to 14, with a higher score indicating worse scarring. Scars were analyzed by three blinded plastic surgeons, who evaluated frontal and basal photographs of participants. The median of the three surgeon scores per participant was first calculated, and then the median all medians was calculated per arm.

  6 months

• Hypertrophic Scarring (HTS) as Assessed by Score on the Manchester Scar Scale (MSS) Rated by Blinded Plastic Surgeons

  The Manchester Scar Scale (MSS) assesses color match to surrounding skin, skin texture, contour, and distortion, and total MSS score ranges from 4 to 14, with a higher score indicating worse scarring. Scars were analyzed by three blinded plastic surgeons, who evaluated frontal and basal photographs of participants. The median of the three surgeon scores per participant was first calculated, and then the median all medians was calculated per arm.

  12 months

• Hypertrophic Scarring (HTS) as Assessed by Score on the Modified Scar Rating Scale (MSRS) Rated by Blinded Plastic Surgeons

  The Modified Scar Rating Scale (MSRS) assesses surface appearance, scar height, and color mismatch, and total MSRS score ranges from 3 to 12, with a higher score indicating worse scarring. Scars were analyzed by three blinded plastic surgeons, who evaluated frontal and basal photographs of participants. The median of the three surgeon scores per participant was first calculated, and then the median all medians was calculated per arm.

  6 months

• Hypertrophic Scarring (HTS) as Assessed by Score on the Modified Scar Rating Scale (MSRS) Rated by Blinded Plastic Surgeons

  The Modified Scar Rating Scale (MSRS) assesses surface appearance, scar height, and color mismatch, and total MSRS score ranges from 3 to 12, with a higher score indicating worse scarring. Scars were analyzed by three blinded plastic surgeons, who evaluated frontal and basal photographs of participants. The median of the three surgeon scores per participant was first calculated, and then the median all medians was calculated per arm.

  12 months

• Hypertrophic Scarring (HTS) as Assessed by Score on the Manchester Scar Scale (MSS) Rated by Crowdsourced Raters

  The Manchester Scar Scale (MSS) assesses color match to surrounding skin, skin texture, contour, and distortion, and total MSS score ranges from 4 to 14, with a higher score indicating worse scarring. Scars were analyzed by crowdsourced raters via Amazon Mechanical Turk. The crowdsourced raters evaluated frontal and basal photographs of participants. 100 unique responses were elicited per participant. The mean of all crowdsourced ratings for each arm is reported per arm.

  6 months

• Hypertrophic Scarring (HTS) as Assessed by Score on the Manchester Scar Scale (MSS) Rated by Crowdsourced Raters

  The Manchester Scar Scale (MSS) assesses color match to surrounding skin, skin texture, contour, and distortion, and total MSS score ranges from 4 to 14, with a higher score indicating worse scarring. Scars were analyzed by crowdsourced raters via Amazon Mechanical Turk. The crowdsourced raters evaluated frontal and basal photographs of participants. 100 unique responses were elicited per participant. The mean of all crowdsourced ratings for each arm is reported per arm.

  12 months

• Hypertrophic Scarring (HTS) as Assessed by Score on the Modified Scar Rating Scale (MSRS) Rated by Crowdsourced Raters

  The Modified Scar Rating Scale (MSRS) assesses surface appearance, scar height, and color mismatch, and total MSRS score ranges from 3 to 12, with a higher score indicating worse scarring. Scars were analyzed by crowdsourced raters via Amazon Mechanical Turk. The crowdsourced raters evaluated frontal and basal photographs of participants. 100 unique responses were elicited per participant. The mean of all crowdsourced ratings for each arm is reported per arm.

  6 months

• Hypertrophic Scarring (HTS) as Assessed by Score on the Modified Scar Rating Scale (MSRS) Rated by Crowdsourced Raters

  The Modified Scar Rating Scale (MSRS) assesses surface appearance, scar height, and color mismatch, and total MSRS score ranges from 3 to 12, with a higher score indicating worse scarring. Scars were analyzed by crowdsourced raters via Amazon Mechanical Turk. The crowdsourced raters evaluated frontal and basal photographs of participants. 100 unique responses were elicited per participant. The mean of all crowdsourced ratings for each arm is reported per arm.

  12 months

Study Arms (2)

Botulinum Toxin

EXPERIMENTAL

Injection of botulinum toxin into cleft lip at time of surgical repair.

Drug: Botulinum Toxin Type A

Saline

PLACEBO COMPARATOR

Injection of normal saline into cleft lip at time of surgical repair.

Drug: Normal Saline Injection

Interventions

Botulinum Toxin Type A DRUG

Injection of botulinum toxin at the time of surgery at cleft lip repair site. Botulinum toxin will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair.

Botulinum Toxin

Normal Saline Injection DRUG

Injection of normal saline into cleft lip at time of surgical repair. Saline will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair.

Saline

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• complete unilateral cleft lip with or without cleft palate
• planned for a primary cleft lip repair

You may not qualify if:

• bilateral cleft lip

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Related Publications (11)

• Pascual-Pascual SI, Pascual-Castroviejo I. Safety of botulinum toxin type A in children younger than 2 years. Eur J Paediatr Neurol. 2009 Nov;13(6):511-5. doi: 10.1016/j.ejpn.2008.10.006. Epub 2008 Nov 25.

  PMID: 19036619 BACKGROUND

• Galarraga IM. Use of botulinum toxin in cheiloplasty: A new method to decrease tension. Can J Plast Surg. 2009 Fall;17(3):e1-2. doi: 10.1177/229255030901700313.

  PMID: 20808741 BACKGROUND

• Alvarez CM, De Vera MA, Chhina H, Williams L, Durlacher K, Kaga S. The use of botulinum type A toxin in the treatment of idiopathic clubfoot: 5-year follow-up. J Pediatr Orthop. 2009 Sep;29(6):570-5. doi: 10.1097/BPO.0b013e3181b2b3d4.

  PMID: 19700985 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

• Christiansen G, Mohney BG, Baratz KH, Bradley EA. Botulinum toxin for the treatment of congenital entropion. Am J Ophthalmol. 2004 Jul;138(1):153-5. doi: 10.1016/j.ajo.2004.02.023.

  PMID: 15234303 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

• Sykes JM. Management of the cleft lip deformity. Facial Plast Surg Clin North Am. 2001 Feb;9(1):37-50.

  PMID: 11465005 BACKGROUND

• Seibert RW. Bilateral cleft nasal repair. Facial Plast Surg. 2000;16(1):69-78. doi: 10.1055/s-2000-7328.

  PMID: 11802349 BACKGROUND

• Millard DR Jr. Embryonic rationale for the primary correction of classical congenital clefts of the lip and palate. Ann R Coll Surg Engl. 1994 May;76(3):150-60.

  PMID: 8017808 BACKGROUND

• Witt PD, Hardesty RA. Rotation-advancement repair of the unilateral cleft lip. One center's perspective. Clin Plast Surg. 1993 Oct;20(4):633-45.

  PMID: 8275629 BACKGROUND

• Lee JS, Lee KB, Lee YR, Choi YN, Park CW, Park SD, Jung DH, Lee CS. Botulinum Toxin Treatment on Upper Limb Function in School Age Children With Bilateral Spastic Cerebral Palsy: One Year Follow-up. Ann Rehabil Med. 2013 Jun;37(3):328-35. doi: 10.5535/arm.2013.37.3.328. Epub 2013 Jun 30.

  PMID: 23869330 BACKGROUND

MeSH Terms

Conditions

Cleft Lip; Cicatrix; Cleft Palate

Interventions

Botulinum Toxins, Type A; Saline Solution

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities

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

Limitations and Caveats

Small sample size; inconsistency in acquiring post-op photos for some; 12 month analysis may be skewed by Botox's short duration of action; crowdsourced raters were not a generalized sample of the population

Results Point of Contact

• Title: Matthew R. Greives, MD
• Organization: The University of Texas Health Science Center at Houston

Matthew.R.Greives@uth.tmc.edu

713-500-7275

Study Officials

• Jaecel O Shah, MD

  UTHealth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 17, 2014
• First Posted: September 23, 2014
• Study Start: December 1, 2015
• Primary Completion: January 13, 2020
• Study Completion: January 13, 2020
• Last Updated: November 3, 2021
• Results First Posted: November 3, 2021

Record last verified: 2021-10

Locations

US (1)