RecruitingPhase 2ACTRN12614000196640

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


Sponsor

David Ellis

Enrollment

20 participants

Start Date

Feb 24, 2014

Study Type

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

Sex: Both males and femalesMin Age: 40 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether tiny injections of Botox (onabotulinumtoxin A) into the cheek skin can reduce the appearance of accordion-style wrinkles that appear when you smile. It is a split-face trial, meaning one side of the face gets the real treatment and the other side gets a placebo, so each person acts as their own comparison. Researchers will measure wrinkle improvement, skin elasticity, and patient satisfaction. You may be eligible if: - You are between 40 and 75 years old - You have visible cheek (accordion) wrinkles you want treated - Your wrinkles are at least grade 1 at rest or when smiling widely - You are mentally able to give your own consent - You are able to attend follow-up appointments for the duration of the study - If you take low-dose aspirin (81 mg), you are willing to stop it two weeks before the trial You may NOT be eligible if: - You are pregnant or breastfeeding - You have previously had Botox injections in your cheeks - You have had an allergic reaction to botulinum toxin before - You have had ablative laser treatment on your cheeks - You have had non-ablative laser treatment on your cheeks in the last 6 months - You have had surgery in your cheek area - You have a muscle or nerve disease such as myasthenia gravis or ALS Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 volum

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)

Ontario, Canada

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ACTRN12614000196640