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The effect and safety of Meditoxin® (Botulinum toxin) injection in chronic sialoadenitis

The multi-center clinical trial on the recurrence prevention and safety by injection of Meditoxin® (Botulinum toxin) in chronic sialoadenitis patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0004028
Enrollment
22
Registered
2019-06-03
Start date
2019-01-24
Completion date
Unknown
Last updated
2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug, Procedure/Surgery : Injection drug: Meditoxin® (Botulinum toxin) Dose: Parotid gland (25 IU), Submandibular gland (8IU) Number and Duration: Once Injection pathway: Direct injection into salivar

Sponsors

Bundang CHA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The enrolled patient should comply with all of the following criteria. 1) Men and women over 20 and under 70 2) The patient who have experienced symptoms for more than 6 months 3) The patient who repeat 3 or more episodes of sialoadenitis 4) The patient who voluntarily decided to participate and signed the consent form before starting this clinical trial

Exclusion criteria

Exclusion criteria: Patients who fall under any of the following criteria are not allowed to register for this clinical trial. 1) Patients who have been confirmed to have a stone or tumor in the salivary gland by CT or MRI 2) Patients with salivary glands hypertrophy without pain or pressure sense 3) Patients who participated in other clinical trials within last 1 month 4) Patients with less than a longer period of five times the half-life of medicines in previous clinical trials 5) Patient who have the contraindication of Meditoxin 6) In addition to the above, patients who are deemed inappropriate for this trial by investigator

Design outcomes

Primary

MeasureTime frame
Questionaire (frequency and intensity of pain, frequency and intensity of swelling);SPECT-CT (Single Photon Emission Computed Tomography-Computed Tomography)

Secondary

MeasureTime frame
Salivary flow test

Countries

Korea, Republic of

Contacts

Public ContactJin Cheon

Bundang CHA General Hospital

cjin81@chamc.co.kr+82-31-780-5327

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026