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Treatment for "Asymmetric Crying Facies"

23. september 2026 oppdatert av: Xiaolei Jin

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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Xiaoshuang Guo, M.D.
  • Telefonnummer: +86 13121234163
  • E-post: gxsinjnu@126.com

Studiesteder

      • Beijing, Kina
        • Rekruttering
        • Plastic Surgery Hospital & Chinese Academy Of Medical Sciences
        • Ta kontakt med:
        • Hovedetterforsker:
          • Xiaoshuang Guo, M.D.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

5 år til 18 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. 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.
  2. Subjects who are able to comply with study protocols and visit schedules.
  3. Subjects whose guardians provide voluntary written informed consent.

Exclusion Criteria:

  1. 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.

  2. Receiving treatment with any of the following medications:

    1. 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.
    2. Anticoagulants or anti-platelet agents used within 7 days before study drug administration.
  3. Cutaneous abnormalities at the treatment site, including local infection (e.g., herpes simplex, acne, erysipelas), scars, hypertrophic scars, or keloid predisposition.

  4. Prior perioral treatment within 1-year interval before this study.

  5. 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).

  6. Presence of other comorbidities that render the subject inappropriate for enrollment at the investigator's discretion. Eligibility shall be determined by the investigator.

  7. 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.

  8. Subjects unable to communicate or incapable of following study instructions.

  9. Staff members of the study department or sponsor.

  10. Subjects considered unsuitable for participation in this study by the investigator.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Intervention Group

Participants receive botulinum toxin injection immediately after enrollment for correction of crooke

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

Aktiv komparator: Control Group (Delayed Treatment)

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.

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
mouth asymmetry
Tidsramme: 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

1、3、6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
satisfaction with lips
Tidsramme: 1、3、6 months

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).

1、3、6 months
Terzis aesthetic and functional grading system for the depressor muscle
Tidsramme: 1、3、6 months

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.

1、3、6 months
Smile Improvement Score
Tidsramme: 1、3、6 months

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.

1、3、6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

7. august 2026

Primær fullføring (Antatt)

31. desember 2029

Studiet fullført (Antatt)

31. desember 2029

Datoer for studieregistrering

Først innsendt

30. august 2026

Først innsendt som oppfylte QC-kriteriene

30. august 2026

Først lagt ut (Faktiske)

3. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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