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A Randomized, Double-Blind, Controlled Study Evaluating the Efficacy of Botulinum Toxin Type A (Hengli) Injection for LowerLip Asymmetry in Children With Craniofacial Microsomia

NCT07802639 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-09-03

No results posted yet for this study

Summary

This study focuses on children with hemifacial microsomia (HFM), a common congenital craniofacial deformity caused by abnormal development of the first and second branchial arches. Up to 45% of children with HFM have facial nerve dysplasia, most frequently involving the mandibular marginal branch. These children present with asymmetric lower-lip movement called "crooked-mouth smile" during smiling, speaking or crying. Unlike asymmetric crying syndrome, this condition does not resolve spontaneously and may gradually get worse.

"Crooked-mouth smile" results from muscle weakness of the lower lip on the affected side, leading to dynamic perioral muscle imbalance. Static treatment includes botulinum toxin injection, muscle resection, nerve cutting and fascia suspension; dynamic treatment includes muscle transfer procedures. Early intervention is important for children's psychological well-being. Botulinum toxin injection is minimally invasive, safe and reversible, and is regarded as a preferred initial therapy. However, prospective clinical evidence regarding its efficacy, safety and appropriate dosage in this pediatric population remains insufficient. This prospective study aims to explore the safety, effectiveness and optimal dose of botulinum toxin injection for treating "crooked-mouth smile" in children with HFM and mandibular marginal branch dysplasia.

Conditions

  • Hemifacial Microsomia; Facial Nerve Branch Dysplasia; Crooked-Mouth Smile Deformity

Interventions

PROCEDURE

Botulinium toxin type A injection

Injection targets the "depressor labii inferioris" and "depressor anguli oris" for correction of crooked-mouth smile.

Sponsors & Collaborators

  • Peking Union Medical College

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-07
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07802639 on ClinicalTrials.gov