Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Lateral Canthal Lines
Phase 2
Completed
- Conditions
- Lateral Canthal Lines
- Interventions
- Drug: PlaceboDrug: MBA-P01(Botulinum toxin A)
- Registration Number
- NCT04143854
- Lead Sponsor
- Medy-Tox
- Brief Summary
This phase 2 study includes two treatment period; 1)Dose- ranging period, Day 0 to 16 weeks, which will assess dose-related safety/tolerance, and the potential to improve the appearance of lateral canthal lines and 2) open-label extension period, 16 weeks to 52 weeks, which will evaluate the long term-safety of MBA-P01
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
- Male or female aged 18 to 65
- Bilaterally symmetrical moderate to severe lateral canthal lines(LCLs) at maximum smile as assessed by both investigator and subject using FWS
Exclusion Criteria
- History of facial nerve paralysis
- Any eyebrow or eyelied ptosis as determined by the investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo group; normal saline MBA-P01 12U MBA-P01(Botulinum toxin A) Experimental group; Dose: 12U MBA-P01 24U MBA-P01(Botulinum toxin A) Experimental group; Dose: 24U
- Primary Outcome Measures
Name Time Method Facial wrinkle scale(FWS) change of lateral canthal line at maximum smile 4 weeks Proportion of subjects achieving at least a 2 grade decrease from baseline and a grade 0 or 1 in Facial Wrinkle Scale (0: none to 3: severe) of LCL at maximum smile, as assessed by the investigator and subject
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Maroubra Medical Centre
🇦🇺Maroubra, New South Wales, Australia