Do you have frown lines between your eyebrows?
Consider Participating in the Pacific Clinical Study.
A clinical research study for people with moderate to severe frown lines between the eyebrows.
What is a clinical research study?
A clinical research study is carefully designed medical research with human volunteers to learn more about investigational drugs. An investigational drug is a potential treatment that has not been approved for use outside of this study by national health authorities.
What should I do if I am interested and still have questions?
If you think the Pacific clinical study could be for you, please talk to the study doctor or staff. They are available to answer any questions you may have. Your participation in this clinical study is voluntary. You may decide to not participate or stop participating in this study at any time. You may also find useful resources online about clinical studies.
Here are some examples that can help you:
- Understand more about clinical research at www.hhs.gov/About-Research-Participation
- Learn more about what participating may mean for you by visiting AbbVie’s online resource at www.AbbVieClinicalTrials.com
Who can participate in these studies?
You may qualify to participate if you meet the following requirements:
- 18 years of age or older (men and women of all ethnicities)
- Have moderate to severe frown lines between the eyebrows
- No use of botulinum toxin within the last 6 months for aesthetic treatment and 12 months for therapeutic treatment
What is the study treatment?
The Investigational study drug, which contains Botulinum Neurotoxin Serotype E (BoNT/E) as the active ingredient, is being studied in participants with moderate to severe frown lines between the eyebrows. The safety and efficacy of this investigational drug have not been established. Frown lines are wrinkles between the eyebrows and result from the repeated muscle movements associated with common facial expressions. You should ask the study staff any questions about the investigational drug, including potential side effects and standard treatments available for frown lines.
What happens if I want to participate?
Your ability to participate involves a few different steps to determine if you qualify for the clinical study:
- Informed consent: agreeing to participate in the clinical study after reviewing the Informed Consent Form with the study staff.
- Screening: undergoing screening study procedures to determine if you qualify for the
clinical study, including answering questions about your demographics, medical history, medication, and frown lines.
If you still qualify after these steps, you will move into the clinical study treatment period.
What will my commitment look like?
Once you enter the clinical study, you may be required to attend up to 20 clinic visits or phone calls and complete all study procedures.
- Visit frequency: You will receive up to 3treatments of the investigational drug at 6-week intervals with 5 follow-up visits after each.
- Visit length: About 1-2 hours for an in-clinic visit and 10–15 minutes for the phone call.
- Study length: 18 weeks
For the in-clinic visits, you may be reimbursed for your travel expenses. While you’re involved in this clinical study, all study-related care will be provided at no cost.
About the Pacific Clinical Study
This study is a Phase 3 study, where researchers observe the investigational drug's safety in participants with moderate to severe frown lines and monitor its side effects after repeated treatments. If you decide to participate, we’ll closely monitor
your health and protect your privacy.
To see if you qualify, please contact:
Name: Joana Fragata Andreae
Phone: (971) 865-5856
Email: joana@pdxderm.com
