Botulinum Toxin to Improve Cosmesis of Primary Cleft Lip Repair

The University of Texas System (UT)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Cleft Palate; Cleft Lip; Scarring

Treatments: Drug: Normal Saline Injection; Drug: Botulinum Toxin Type A

Study type: Interventional

Funder types: Other

Identifiers

NCT02247193

HSC-MS-14-0335

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: Under 6 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

-bilateral cleft lip

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Botulinum Toxin

Experimental group

Description:

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

Treatment:

Drug: Botulinum Toxin Type A

Saline

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal Saline Injection