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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07802639
- Acronym / sponsor ID
- 2024(170)
- Conditions
- Hemifacial Microsomia, Facial Nerve Paralysis
- Keywords
- Hemifacial microsomia, Botulinum toxin, Facial nerve dysplasia, Crooked-mouth smile
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xiaolei JinUniversity, hospital or other
- Study start
- 7 Aug 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Procedure: Botulinium toxin type A injectionParticipants receive botulinum toxin injection immediately after enrollment for correction of crooke |
| Control Group (Delayed Treatment) | Active comparator | Procedure: Botulinium toxin type A injectionarticipants 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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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:
- 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.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinium toxin type A injectionInjection targets the "depressor labii inferioris" and "depressor anguli oris" for correction of crooked-mouth smile. | Procedure or surgery | Control Group (Delayed Treatment), Intervention Group |
Primary outcome
mouth asymmetry
Time frame: 1、3、6 months
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
3 secondary outcomes
satisfaction with lips
Time frame: 1、3、6 months
Terzis aesthetic and functional grading system for the depressor muscle
Time frame: 1、3、6 months
Smile Improvement Score
Time frame: 1、3、6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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Hemifacial Microsomia, Mucormycosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoshuang Guo, M.D. (+86 13121234163, gxsinjnu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mouth asymmetry (time frame: 1、3、6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026; AzTrials last refreshed its copy on 2 Nov 2026.