Hemifacial MicrosomiaNCT07802639
Treatment for "Asymmetric Crying Facies"
A study testing Botulinium toxin type A injection in people with Hemifacial Microsomia and Facial Nerve Paralysis, run by Xiaolei Jin at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Hemifacial Microsomia, Facial Nerve Paralysis
- What is being tested?
- Botulinium toxin type A injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 7 Aug 2026to 31 Dec 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children under 18 years old diagnosed with hemifacial microsomia (HFM) and lower-lip asymmetry, with congenital injury of the marginal mandibular branch of the facial nerve, presenting with lower-lip movement disorder and lower-lip asymmetry during smiling and teeth-baring.
- Subjects who are able to comply with study protocols and visit schedules.
- Subjects whose guardians provide voluntary written informed consent.
Who cannot join
- Any disease affecting neuromuscular function, including but not limited to neuromuscular junction disorders such as myasthenia gravis and Lambert-Eaton syndrome, peripheral motor nerve diseases such as amyotrophic lateral sclerosis, or a past medical history of the above-mentioned diseases.
- Receiving treatment with any of the following medications:
- Within 4 weeks prior to screening: muscle relaxants (tubocurarine chloride, dantrolene sodium, baclofen, etc.), aminoglycosides, polypeptide antibiotics, spectinomycin hydrochloride, tetracyclines, lincomycin, anticholinergic agents (butylscopolamine bromide, trihexyphenidyl hydrochloride, etc.), benzodiazepines, and other drugs that may inhibit neuromuscular transmission or interfere with the effect of botulinum toxin.
- Anticoagulants or anti-platelet agents used within 7 days before study drug administration.
- Cutaneous abnormalities at the treatment site, including local infection (e.g., herpes simplex, acne, erysipelas), scars, hypertrophic scars, or keloid predisposition.
- Prior perioral treatment within 1-year interval before this study.
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- History of hypersensitivity; known allergy to any component of the investigational or comparator product, or known sensitivity to complex protein components (including botulinum toxin type A, human albumin, gelatin protein, lactose, sodium chloride, or sodium succinate).
- Presence of other comorbidities that render the subject inappropriate for enrollment at the investigator's discretion. Eligibility shall be determined by the investigator.
- Participation in another clinical trial (drug or device-related) at the time of screening, or participation in any other clinical trial within 30 days before screening.
- Subjects unable to communicate or incapable of following study instructions.
- Staff members of the study department or sponsor.
- Subjects considered unsuitable for participation in this study by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Plastic Surgery Hospital & Chinese Academy Of Medical Sciences
Beijing
Xiaoshuang Guo, M.D., 86-13121234163, gxsinjnu@126.com
Xiaoshuang Guo, M.D.
About this study
Official title: A Randomized, Double-Blind, Controlled Study Evaluating the Efficacy of Botulinum Toxin Type A (Hengli) Injection for LowerLip Asymmetry in Children With Craniofacial Microsomia
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 Paralysis
- Being tested
- Botulinium toxin type A injection
- Keywords
- Hemifacial microsomia, Botulinum toxin, Facial nerve dysplasia, Crooked-mouth smile
- Medical subject headings
- Goldenhar Syndrome, Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinium toxin type A injectionProcedure or surgery
Injection targets the "depressor labii inferioris" and "depressor anguli oris" for correction of crooked-mouth smile.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants receive botulinum toxin injection immediately after enrollment for correction of crooke Receives: Procedure: Botulinium toxin type A injection |
| Control Group (Delayed Treatment) | Active comparator | articipants do not receive botulinum toxin injection at baseline. After completing 6-month follow-up assessment for primary outcomes, subjects in this group will receive botulinum toxin injection. Receives: Procedure: Botulinium toxin type A injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
mouth asymmetry
A coordinate system is established based on the palpebral fissure and nasion. The sagittal distance differences at the hemilabial midpoint and oral commissure point are evaluated under static, broad-smile, and teeth-baring conditions in children
Measured: 1、3、6 months
Secondary outcomes (3)
satisfaction with lips
Face-Q: satisfaction with lips. FACE-Q Aesthetics: Satisfaction with Lips scale. Patient-reported satisfaction with lip appearance. Rasch-transformed scores range from 0 to 100; higher scores indicate greater satisfaction (better outcome).
Measured: 1、3、6 months
Terzis aesthetic and functional grading system for the depressor muscle
Investigator-assessed depressor muscle aesthetic and functional performance using the Terzis aesthetic and functional grading system for the depressor muscle. Scores range from 0 (Poor, total paralysis) to 2 (Excellent, normal symmetric lower-lip movement); higher scores indicate better aesthetic and functional outcomes.
Measured: 1、3、6 months
Smile Improvement Score
Investigator-assessed improvement in smile aesthetics using the Smile Improvement Score (SIS), a subjective grading system for lip posture during smile. Frontal smile photographs are compared with baseline; scores range from 0(no improvement) to 3 (excellent improvement, symmetric smile); higher scores indicate better smile outcome.
Measured: 1、3、6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start7 Aug 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemifacial MicrosomiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaolei Jin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaolei Jin, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802639
- Sponsor's protocol ID
- 2024(170)
- Status last verified
- Sep 2026
- First submitted
- 30 Aug 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No