- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07802639
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
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
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
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
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Kontakt:
- Xiaoshuang Guo, M.D.
- Telefonnummer: 86-13121234163
- E-post: gxsinjnu@126.com
-
Huvudutredare:
- Xiaoshuang Guo, M.D.
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 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.
Exclusion Criteria:
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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.
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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.
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Cutaneous abnormalities at the treatment site, including local infection (e.g., herpes simplex, acne, erysipelas), scars, hypertrophic scars, or keloid predisposition.
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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).
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Presence of other comorbidities that render the subject inappropriate for enrollment at the investigator's discretion. Eligibility shall be determined by the investigator.
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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.
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Subjects unable to communicate or incapable of following study instructions.
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Staff members of the study department or sponsor.
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Subjects considered unsuitable for participation in this study by the investigator.
Studieplan
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
|
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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
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Skelettsjukdomar
- Muskuloskeletala sjukdomar
- Munsjukdomar
- Stomatogena sjukdomar
- Sjukdomar i nervsystemet
- Infektioner
- Virussjukdomar
- DNA-virusinfektioner
- Kraniofaciala abnormiteter
- Muskuloskeletala abnormiteter
- Medfödda abnormiteter
- Herpesviridae-infektioner
- Kranial nervsjukdomar
- Bensjukdomar, utvecklingsmässiga
- Ansiktsnervssjukdomar
- Dysostoser
- Kraniofacial dysostos
- Mandibulofacial dysostos
- Medfödda, ärftliga och neonatala sjukdomar och abnormiteter
- Bell Pares
- Goldenhars syndrom
Andra studie-ID-nummer
- 2024(170)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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