Phase IV Study On Muscle Activity Of Two Commercial Preparations Of Botulinum
- Sponsor
- Hexsel Dermatology Clinic
- Study ID
- NCT01728337
- Phase
- PHASE4
- Status
- Completed
Conditions
- Sun-induced Wrinkles
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 60 Years
- Healthy Volunteers
- Accepted
Interventions
- Dysport — DRUGDysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead.
- Xeomin — DRUGXeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead
Study Details
this study was proposed to provide more scientific and objective data on the clinical and aesthetic effects of these two toxins (Dysport and Xeomin).
Key Dates
- Start date
- Jul 31, 2011
- Status verified
- Jul 2019
- Primary completion
- Feb 29, 2012
- Completion
- Feb 29, 2012
Study Design
- Enrollment
- 80 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Dysport and Xeomin30 U of Dysport® was injected on the right side of the forehead and 12 U Xeomin® was injected on the left side of the forehead (dose-equivalence 2.5:1).
- Active Comparator: Xeomin and Dysport30 U Dysport® was injected on the left side of the forehead and 12 U Xeomin® was injected on the right side of the forehead (dose-equivalence 2.5:1).
Primary Outcome Measure
Percentage of Responders After 5 Months After the Procedure [ Time Frame: 5 months after intervention ]