Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Lateral Canthal Lines
NCT04143854 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2021-03-19
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
Conditions
- Lateral Canthal Lines
Interventions
- DRUG
-
MBA-P01(Botulinum toxin A)
Intramuscular injection; Dose varies by group
- DRUG
-
Intramuscular injection; normal saline
Sponsors & Collaborators
-
Medy-Tox
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-05-21
- Primary Completion
- 2020-08-19
- Completion
- 2020-08-19
Countries
- Australia
Study Locations
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