Onabotulinum Toxin Type A and Abobotulinum Toxin Type A Crow's Feet Rhytid Study (NCT01529788) | Clinical Trial Compass
CompletedPhase 4
Onabotulinum Toxin Type A and Abobotulinum Toxin Type A Crow's Feet Rhytid Study
United States90 participantsStarted 2009-09
Plain-language summary
The objective of the study is to compare the time to onset of Dysport® versus Botox® in the treatment of lateral orbital rhytids ("crow's feet"). Thirty subjects were enrolled in the study; specifically 30 male or female patients 18 years or older with moderate to severe lateral orbital rhytids at maximum contracture. Each patient were randomized to be treated with Dysport® on one side and Botox® on the other side. Both the injector and patient were blinded to the injected toxin.
The efficacy endpoints were determined by investigator and subject live assessment of "crow's feet" at rest and maximum contraction at each visit (every other day for 6 days post-injection, every month for 9 months following) using a validated 5 point photographic scale(no wrinkles \[0\], very fine wrinkles \[1\], fine wrinkles \[2\], moderate wrinkles \[3\] or severe wrinkles \[4\]) used in previous studies. A written description of each photograph was included to help standardize the application of the Photographic Scale.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Male or female patients who meet all of the following criteria are eligible for this study:
* Eighteen years of age or older.
* Moderate to severe lateral orbital rhytids at maximum smile (score of \[2\] or \[3\] by physician assessment)
* Negative pregnancy test for females of childbearing potential.
* Time and ability to complete the study and comply with instructions.
* Understanding of the study and contents of the informed consent.
Exclusion Criteria:
Patients who meet any of the following criteria are not eligible for this study:
* Previous treatment to the glabellar area, forehead or lateral orbital rhytids with Dysport® or Botox® Cosmetic or other botulinum toxin within 180 days of entry into the study. Botulinum toxin treatment of areas other than the lateral orbital rhytids at any time during the study.
* Patients with an ongoing treatment-related AE from any Dysport® or Botox® Cosmetic or botulinum toxin study.
* Inability to substantially lessen lateral orbital lines by physically spreading them apart.
* Permanent or semi-permanent dermal fillers in the lateral orbital rhytids at any time.
* Ablative skin resurfacing on the lateral orbital rhytids at any time preceding the study or planning to during the current study.
* Upper eyelid blepharoplasty or brow lift at any time preceding the study or planning to during the current study.
* Non-ablative treatments in the lateral orbital region for skin dyschromias (e.g. Intense Pulsed Light, lig…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To compare the time to onset of action, efficacy and duration of Dysport® versus Botox® Cosmetic in the treatment of lateral orbital rhytids.