Botulinum Toxin to Improve Cosmesis of Primary Cleft Lip Repair

Purpose

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

Eligibility

Eligible Ages
Under 6 Months
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • bilateral cleft lip

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Botulinum Toxin 		Injection of botulinum toxin into cleft lip at time of surgical repair.
  • Drug: Botulinum Toxin Type A
    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.
Placebo Comparator
Saline 		Injection of normal saline into cleft lip at time of surgical repair.
  • Drug: Normal Saline Injection
    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.

More Details

Status
Completed
Sponsor
The University of Texas Health Science Center, Houston

Study Contact