Moderate to Severe Glabellar Lines
Conditions
Keywords
Moderate to Severe Glabellar Lines
Brief summary
This is a Phase 3 clinical study to evaluate the efficacy, safety, and immunogenicity of single/repeated injections of Eveotox in the treatment of moderate to severe glabellar lines. The study consists of Study Part 1 (randomized double-blind controlled study) and Part 2 (open-label study). Part I is a multicenter, randomized, double-blind, single-injection, active-controlled and placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of Eveotox in the treatment of moderate to severe glabellar lines; Part 2 is an open-label study to evaluate the efficacy, safety, and immunogenicity of repeated injections of Eveotox in the treatment of moderate to severe glabellar lines.
Interventions
BIOLOGICALRcombinant botulinum toxin type A for injection（Eveotox)
Rcombinant botulinum toxin type A for injection（Eveotox)
BIOLOGICALOnabotulinumtoxinA (Botox)
OnabotulinumtoxinA (Botox)
BIOLOGICALPlacebo
Placebo
Sponsors
JHM BioPharma (Tonghua) Co. , Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Biological: Rcombinant botulinum toxin type A for injection (Eveotox) Biological: OnabotulinumtoxinA (Botox) Biological: : Placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female subjects who are between 18 to 65 years of age * Moderate or severe glabellar lines during maximum frown based on the Investigator Global Assessment Frown Wrinkle Severity scale * Moderate or severe glabellar lines during maximum frown based on the Patient Frown Wrinkle Severity scale * Willing and able to follow all trial procedures, attend all scheduled visits, and successfully complete the trial
Exclusion criteria
* Subjects who have a history of oversensitivity to the Botulinum Toxin A type or other components of the study drug * Subjects who have implanted any permanent materials in the glabellar area or received semi-permanent fillers within the first 2 years of screening * Subjects with active skin infections at the injection site or systemic skin disease, which the investigator judges can affect the evaluation of efficacy or safety * Subjects who have a history of injecting drugs similar to the study drug within 6 months prior to selection or are foreseen to use during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome Measure | Within 4 weeks | Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 2 points in FWS score (at maximum frown) at week 4 visit relative to baseline, based on both the investigators´ and the subjects´ in-clinic assessments. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome Measure | Within 52 weeks | Incidence of serious adverse events and drug-related adverse events during the study. |
Countries
China
Contacts
CONTACTDanhua Lin
CONTACTLei Wang
Outcome results
None listed