Evaluation of the efficacy of intradermal onabotulinumtoxinA for the treatment of accordion (cheek) wrinkles: A 2-centre randomized double-blinded split face clinical trial
Evaluation of the efficacy of intradermal onabotulinumtoxinA for the treatment of accordion wrinkles: A 2-centre randomized double-blinded split face clinical trial
David Ellis
20 participants
Feb 24, 2014
Interventional
Conditions
Summary
This study aims to evaluate the efficacy of intradermal onabotulinumtoxin A injection for the treatment of accordion (cheek) wrinkles as compared to placebo in a split face randomized and double blinded trial, in terms of improvement of wrinkles based on serial photographs, improvement in skin elasticity and patient's satisfaction. The hypothesis is that intradermal onabotulinumtoxinA is effective in treating accordion wrinkles and improving the skin elasticity, and with good patient's satisfaction.
Eligibility
Inclusion Criteria6
- All male and female patients between ages of 40 - 75 complaining of accordion wrinkles and keen for intervention only for the accordion wrinkles.
- Accordion wrinkles of at least grade 1 at rest and/or on extreme smile.
- Of sound mind and able to give consent.
- Able to be followed up for duration of study.
- 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)
- Patients that are on ASA 81mg must be off for 2 weeks.
Exclusion Criteria7
- Females who are pregnant or breast-feeding.
- Patients who have previous botulinum toxin A injections at the cheek area.
- Patients who have previous allergy to botulinum toxin A.
- Patients with previous ablative laser procedures in the cheek area.
- Patients with non-ablative laser treatment in cheek area in the last 6 months.
- Patients with incisional surgery in the cheek area.
- Patients who have muscular or neurological diseases such as amyotrophic lateral sclerosis, myasthenia gravis, Lambert-Eaton Syndrome, etc.
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Interventions
Selected patient will have bilateral accordion (cheek) wrinkles and will be randomized to receive 20 units of intradermal onabotulinumtoxin A injection on one side of the face and placebo (equal volume of intradermal normal saline injection) on the contralateral face. Patient will be monitored at 2, 4, 8, 12, and 16 weeks post injection for improvement of accordion wrinkles based on serial photographs assessed by the investigator who is blinded and also changes to the skin elasticity measured by a skin cutometer.
Locations(1)
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ACTRN12614000196640