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Treatment for "Asymmetric Crying Facies"

23 september 2026 uppdaterad 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.

Studieöversikt

Studietyp

Interventionell

Inskrivning (Beräknad)

60

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

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

Studieorter

      • Beijing, Kina
        • Rekrytering
        • Plastic Surgery Hospital & Chinese Academy Of Medical Sciences
        • Kontakt:
        • Huvudutredare:
          • Xiaoshuang Guo, M.D.

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

5 år till 18 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
mouth asymmetry
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
satisfaction with lips
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

7 augusti 2026

Primärt slutförande (Beräknad)

31 december 2029

Avslutad studie (Beräknad)

31 december 2029

Studieregistreringsdatum

Först inskickad

30 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

30 augusti 2026

Första postat (Faktisk)

3 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

28 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

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Nej

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Nej

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