Botulinum toxin for crooked-mouth smile in children with hemifacial microsomia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study focuses on children with hemifacial microsomia who have a crooked-mouth smile due to impaired movement of the lower lip. The intervention uses botulinum toxin type A injections to address dynamic imbalances of perioral muscles. Participants must meet pediatric eligibility criteria and be able to follow study schedules, with guardians providing consent. The trial aims to assess changes in lip movement and cosmetic appearance after treatment. Safety and tolerability of the injections in this specific population will also be monitored.

Why it matters

Who can join: the full rules

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.

Where it's running

• Plastic Surgery Hospital & Chinese Academy Of Medical Sciences
  Beijing, China Recruiting

Study contacts

• Study coordinator: Xiaoshuang Guo, M.D.
• Email: gxsinjnu@126.com
• Phone: +86 13121234163

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.