Botulinum Toxin A Injection for Forehead Wrinkles and Frown Lines

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Northwestern University

Must not be taking: Aminoglycosides, Anticoagulants

Disqualifiers: Pregnancy, Allergies, Bleeding disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well botulinum toxin A injections reduce forehead wrinkles and frown lines. The study compares two groups: one group makes facial expressions after receiving the injection, while the other does not. Researchers aim to determine how quickly the treatment begins to work, its effectiveness, and the duration of results. This trial suits individuals aged 18-65 with forehead and frown lines who plan to receive Botox for these wrinkles. As a Phase 4 trial, it involves an FDA-approved treatment and seeks to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking aminoglycosides or anticoagulation therapy.

What is the safety track record for Botulinum Toxin A?

Research has shown that botulinum toxin A, commonly known as Botox, is generally safe for treating facial wrinkles. Studies have found it effective and it typically doesn't cause serious side effects. Most people tolerate the treatment well. Some might experience minor issues like temporary bruising or redness at the injection site. A review of various studies confirmed that no new serious side effects have been linked to the treatment when used for frown lines and similar conditions. However, treatment by a qualified healthcare provider is important to ensure safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores different techniques for enhancing the effectiveness of Botulinum Toxin A (Botox) injections for forehead wrinkles and frown lines. Unlike traditional procedures where patients are simply injected and advised to go about their day, this trial investigates whether actively making muscle contractions or avoiding them post-injection can influence the results. The key difference here is the focus on immediate post-treatment behavior, which could potentially optimize how well and how quickly Botox works, offering a more tailored approach to achieving smoother skin.

What is the effectiveness track record for Botulinum Toxin A in treating forehead wrinkles and frown lines?

Research has shown that botulinum toxin A effectively reduces forehead and frown lines. Studies have consistently found that this treatment lessens the appearance of facial wrinkles, with patients generally expressing high satisfaction with the results. Botulinum toxin A works by blocking acetylcholine, preventing muscles from tightening and forming wrinkles. The results are reliable, and side effects are usually minor. Noticeable improvements in wrinkles typically appear within four weeks after injections. This treatment is trusted and widely used for reducing facial wrinkles. In this trial, participants will be divided into two groups: one group will perform active muscle contractions for one hour after Botox injections, while the other group will refrain from muscle contractions. ^{1 5 6 7 8}

Who Is on the Research Team?

Murad Alam, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You are in overall good health.

Is willing to return for follow-up visits

I have permanent and movement-related forehead lines.

Exclusion Criteria

Pregnant or lactating

You have an allergy to albumin.

I have had injections to fill in soft tissue areas in the last 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Botox injections with or without muscle contractions

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

13 months

Multiple visits (in-person) at specified intervals

What Are the Treatments Tested in This Trial?

Interventions

• Botulinum Toxin A

Trial Overview 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.

How Is the Trial Designed?

Group I: Muscle contractions Experimental Treatment 1 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 contractions Active Control 1 Intervention

Patients will be asked to not perform muscle contractions following Botox injections.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7874868/

The whole truth about botulinum toxin – a review - PMC This modification may be effective and safe for reducing wrinkles on the forehead [15].

2. medrxiv.org medrxiv.org/content/10.1101/2025.05.14.25327581v1

Efficacy of Botulinum Toxin Type A in Reducing Facial ... Findings indicate that BoNT-A is consistently effective in reducing the severity of dynamic facial wrinkles, with high patient satisfaction reported.

3. aafp.org aafp.org/pubs/afp/issues/2014/0801/p168.html

Botulinum Toxin Injection for Facial Wrinkles Botulinum toxin injection, particularly in the upper one-third of the face, offers predictable results, has few adverse effects, and is ...

4. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD011301.pub2/full

Botulinum toxin type A for facial wrinkles - Camargo, CPires At four weeks after injection, all types of botulinum toxin reduced glabellar lines more than a placebo. This effect was seen whether the ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10374187/

Treatment of crow's feet lines and forehead lines with Botox ... OnabotulinumtoxinA is a highly effective treatment for facial lines that inhibits acetylcholine release at the neuromuscular junction.

6. mayoclinic.org mayoclinic.org/tests-procedures/botox/about/pac-20384658

Botox injections Botox injections are usually safe when you're under the care of a licensed and skilled health care provider. The procedure can result in ...

7. botoxcosmetic.com botoxcosmetic.com/how-it-works/botox-cosmetic-science

BOTOX® Safety and Formulation | Official BOTOX® Cosmetic There has not been a confirmed serious case of spread of toxin effect when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines, crow's ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10682279/

Safety and tolerability of onabotulinumtoxinA in ... This meta-analysis confirms the onabotulinumtoxinA safety profile for GL, CFL, and FHL treatment, with no new onabotulinumtoxinA-associated AEs.