Treatment of Forehead/Glabellar Rhytide Complex With Botulinum Toxin A Injection (NCT01688076) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Treatment of Forehead/Glabellar Rhytide Complex With Botulinum Toxin A Injection
United States25 participantsStarted 2012-01
Plain-language summary
This cross-over design study will evaluate the onset of action, efficacy, and duration of botulinum toxin A treatment on forehead/glabellar rhytid complexes with and without subsequent muscle contraction.
Who can participate
Age range
18 Years – 65 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:
* In good health
* Is 18-65 years of age
* Has static and dynamic forehead/glabellar wrinkles
* Has decided to receive Botox® treatment for their forehead/glabellar wrinkles
* Has the willingness and ability to understand and provide informed consent and communicate with the investigator
* Is willing to return for follow-up visits
Exclusion Criteria:
* Pregnant or lactating
* Has received the following treatments in the forehead or glabellar region:
* botulinum toxin injections in the past 6 months
* ablative laser procedure in the past 6 months
* radiofrequency device treatment in the past 6 months
* ultrasound device treatment in the past 6 months
* medium to deep chemical peel in the past 6 months
* temporary soft tissue augmentation material in the past year
* semi-permanent soft tissue augmentation material in the past 2 years
* permanent soft tissue augmentation material
* Is planning to receive within the next year, any cosmetic procedure (such as any chemical peels, botulinum toxin injections, ablative or non-ablative laser procedures, filler injections, radiofrequency procedures, dermabrasion, ultrasound and face lifting procedures) in the forehead or glabellar region.
* Is planning to use tretinoin or retinoic acid in the next year
* Has an active infection in the forehead or glabellar region (excluding mild acne)
* Is allergic to cow's-milk protein
* Is allergic to albumin
* Taking aminoglycoside
* Is currently using anticoag…
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
Measurement of Forehead Wrinkles with Honeck Four Point Rating Scale