ACTRN12614000196640RecruitingPhase 2
Evaluation of the efficacy of intradermal onabotulinumtoxinA for the treatment of accordion wrinkles: A 2-centre randomized double-blinded split face clinical trial
David Ellis0 sites20 target enrollmentStarted: February 24, 2014Last updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 40 Years to 75 Years (—)
- Sex
- All
Inclusion Criteria
- •1. All male and female patients between ages of 40 - 75 complaining of accordion wrinkles and keen for intervention only for the accordion wrinkles.
- •2. Accordion wrinkles of at least grade 1 at rest and/or on extreme smile.
- •3. Of sound mind and able to give consent.
- •4. Able to be followed up for duration of study.
- •5. Patients can have been their crow’s feet or squint lines treated anytime prior to start of trial. (Different sets of muscles involved and the location of our injections is of adequate distance from squint lines hence will not affect the outcome)
- •6. Patients that are on ASA 81mg must be off for 2 weeks.
Exclusion Criteria
- •1. Females who are pregnant or breast-feeding.
- •2. Patients who have previous botulinum toxin A injections at the cheek area.
- •3. Patients who have previous allergy to botulinum toxin A.
- •4. Patients with previous ablative laser procedures in the cheek area.
- •5. Patients with non-ablative laser treatment in cheek area in the last 6 months.
- •6. Patients with incisional surgery in the cheek area.
- •7. Patients who have muscular or neurological diseases such as amyotrophic lateral sclerosis, myasthenia gravis, Lambert-Eaton Syndrome, etc.
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