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Neurotoxin
Botulinum Toxin A Injection for Forehead Wrinkles and Frown Lines
N/A
Waitlist Available
Led By Murad Alam, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Is 18-65 years of age
Has static and dynamic forehead/glabellar wrinkles
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13 months
Awards & highlights
Study Summary
This trial will study how well botulinum toxin A works to treat wrinkles on the forehead and between the eyebrows, with and without muscle contractions.
Who is the study for?
This trial is for adults aged 18-65 with both static and dynamic forehead/glabellar wrinkles who are in good health and have chosen to receive Botox treatment. Participants must understand the study, consent to it, and commit to follow-up visits. Those with recent cosmetic procedures or botulinum toxin injections, allergies to cow's milk protein or albumin, bleeding disorders, anticoagulant use, active infections in the area (except mild acne), mental illness, pregnancy or lactation are excluded.Check my eligibility
What is being tested?
The study tests Botulinum Toxin A (Botox) on forehead/glabellar wrinkles. It examines how quickly it works, its effectiveness, and how long results last when followed by muscle contractions versus no contractions. This cross-over design means participants will experience both scenarios over time.See study design
What are the potential side effects?
Botulinum Toxin A may cause side effects such as pain at the injection site, headache, temporary eyelid drooping or swelling where injected. Rarely there can be allergic reactions like itching or rash.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Select...
I have permanent and movement-related forehead lines.
Select...
I have chosen to get Botox® for my forehead wrinkles.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 13 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measurement of Forehead Wrinkles with Honeck Four Point Rating Scale
Secondary outcome measures
Level of Satisfaction
Number of Participants with Adverse Events
Side effects data
From 2010 Phase 3 trial • 121 Patients • NCT0098657032%
Injection-site bleeding
21%
Headache
7%
Injection-site pain
5%
Deformity
3%
Injection-site pruritus
2%
Nausea
2%
Eyelid edema
2%
Worsening of baseline wrinkles
1%
Plantar fasciitis
1%
Sore throat
1%
Constipation
1%
Cough
1%
Acute gastroenteritis
1%
Site-injection edema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Xeomin®
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Muscle contractionsExperimental Treatment1 Intervention
Under supervision by study personnel, subjects be asked to make active muscle contractions for one hour after Botox injections. Subjects will return for follow-up visits.
Group II: No muscle contractionsActive Control1 Intervention
Patients will be asked to not perform muscle contractions following Botox injections.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Botulinum Toxin A
2010
Completed Phase 3
~1580
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,206 Total Patients Enrolled
Murad Alam, MDPrincipal InvestigatorNorthwestern University
69 Previous Clinical Trials
2,555 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had injections to fill in soft tissue areas in the last 2 years.You have an allergy to albumin.You are in overall good health.I have received botulinum toxin injections in the last 6 months.I have undergone a laser treatment in the last 6 months.I have undergone radiofrequency device treatment in the last 6 months.I am currently taking aminoglycoside antibiotics.You are allergic to proteins found in cow's milk.I am currently on blood thinners.You have a mental illness.You have had a treatment with an ultrasound device in the last 6 months.I have had a medium to deep chemical peel in the last 6 months.I have had permanent soft tissue fillers.I plan to have a cosmetic procedure on my forehead within a year.I do not have an active infection in my forehead area, except for mild acne.I have a history of bleeding disorders.I understand the study details and can give informed consent.I cannot come back for follow-up visits.I am between 18 and 65 years old.I have permanent and movement-related forehead lines.I can understand and agree to the study's requirements.I plan to use tretinoin or retinoic acid soon.You have had temporary soft tissue fillers injected into your body within the last year.I have chosen to get Botox® for my forehead wrinkles.
Research Study Groups:
This trial has the following groups:- Group 1: Muscle contractions
- Group 2: No muscle contractions
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
New Jersey
What site did they apply to?
Northwestern University Feinberg School of Medicine, Department of Dermatology
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
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