RecruitingNot ApplicableNCT07802639

Treatment for "Asymmetric Crying Facies"

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


Sponsor

Peking Union Medical College

Enrollment

60 participants

Start Date

Aug 7, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 5 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Botulinium toxin type A injection for people with hemifacial microsomia; facial nerve branch dysplasia; crooked-mouth smile deformity. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBotulinium toxin type A injection

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


Locations(1)

Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China, China

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NCT07802639


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