NCT07622004CompletedPhase 3
A Multi-center, Double-blind, Randomized, Parallel, Active-controlled Phase III Trial to Evaluate the Efficacy and Safety of Botulinum Toxin Type A for Injection INI101 Compared to BOTOX® in Subjects With Moderate to Severe Glabellar Lines.
INIBIO Co., Ltd.1 site in 1 country292 target enrollmentStarted: May 27, 2021Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 292
- Locations
- 1
Study Overview
Brief Summary
To evaluate the efficacy and safety of botulinum toxin type A for injection INI101 compared to BOTOX® in subjects with moderate to severe glabellar lines.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 19 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adult male or female participants aged between 19 and 65 years old.
- •Participants whose glabellar line score was 2 (moderate) or higher of glabellar line score at maximum frown based on the investigator's judgment at screening and randomization.
- •Participants who voluntarily gave a consent in writing to participate in the clinical study with full knowledge of details of the study after listening to them.
- •Participants who can understand and comply with the procedures and visit schedules of the study.
Exclusion Criteria
- •Systemic neuromuscular junction disorders (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, hereditary motor neuropathy, etc.)
- •History of blepharoplegia or ptosis
- •Prominent facial asymmetry
- •Glabellar lines that are physically difficult to be improved, such as the case where the lines are not removed by hands
- •Participants who have received any drugs that can act as a systemic muscle relaxant within 4 weeks prior to screening
- •Participants who have received anticoagulants, anti-platelet agents, or systemic NSAIDs within 7 days prior to administration of investigational products (however, low-dose aspirin [325 mg/day or less] administered for antithrombotic purposes is acceptable)
- •Participants who have participated in other clinical trials of a drug/medical device within 30 days from participating in this clinical study and have been administered/treated with the investigational product/medical device
- •Participants deemed ineligible for this study for other reasons based on the investigator's judgment
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
Phase 1 Trial of JTM201 in Subjects With Post-stroke Upper Limb SpasticityNCT07292025Jetema Co., Ltd.30
Not yet recruiting
Phase 2/3
Comparison Of Botulinum Toxin Type A Injection Over Conservative Treatment in dystonic movements associated to specific tasksCTRI/2024/08/072913IPGMER & SSKM Hospital78
Completed
Not Applicable
Repeated Botulinum Toxin Type A Injections on Intramuscular Fat Accumulation in Individuals With Sleep Bruxism.BruxismNCT07266064Melek Volkan Yazici27
Recruiting
Not Applicable
Local Injection of Botulinium Toxin-A in Children With Dysfunctional Voiding or Refractory Nocturnal EneuresisLocal InjectionBotulinium Toxin-AChildrenDysfunctional VoidingRefractory Nocturnal EneuresisNCT07523477Tanta University64
Recruiting
Phase 2
Perineural injections of incobotulinumtoxin-A for diabetic neuropathic pain of the lower extremities: A double-blind, randomized, placebo-controlled study (PINBOT)2022-500727-68-01Rigshospitalet80