What side effects are associated with this type of intervention?

The most common side effects of BOTOX Cosmetic (Botulinum Toxin - Selective Muscle Weakening) include localized pain, swelling, redness, and bruising at the injection site, as well as headache, flu-like symptoms, and temporary drooping of nearby muscles. Injectable fillers can cause similar localized reactions, along with potential lumps or asymmetry. Nonablative skin resurfacing treatments may lead to temporary redness, swelling, and mild discomfort.

What prior FDA approvals exist?

BOTOX Cosmetic (onabotulinumtoxinA) is an FDA-approved treatment for reducing the appearance of wrinkles, specifically glabellar lines, lateral canthal lines, and forehead lines. It works by selectively weakening specific facial muscles to smooth out wrinkles caused by repeated facial expressions. Other similar FDA-approved treatments include Dysport (abobotulinumtoxinA) and Xeomin (incobotulinumtoxinA), which also use botulinum toxin to achieve wrinkle reduction. These treatments are widely used for their efficacy in temporarily improving the appearance of moderate to severe facial lines.

What other types of research exist?

Promising novel alternatives to BOTOX Cosmetic for treating wrinkles in 2024 include: 1) Injectable soft tissue fillers such as hyaluronic acid-based fillers (e.g., Restylane, Juvéderm) which provide volume and stimulate collagen production. 2) Nonablative skin resurfacing techniques using infrared lasers (e.g., 1320 nm Nd:YAG, 1450 nm diode laser) that promote collagen contraction and new collagen formation. 3) Fractional radiofrequency devices that improve skin laxity and rhytides by delivering controlled heat to the dermis. These treatments offer effective, minimally invasive options for wrinkle reduction and skin rejuvenation.

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Neurotoxin

BOTOX for Wrinkles

Phase 4

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderate to severe Glabellar Lines, Lateral Canthal Lines, and Forehead Lines

Sufficient visual acuity without the use of eyeglasses (contact lens use acceptable) to accurately assess their facial wrinkles

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 30

Awards & highlights

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is testing BOTOX Cosmetic, a treatment that reduces wrinkles by weakening certain facial muscles. It targets adults with noticeable lines on their forehead, between their eyebrows, and around their eyes. The study will check how satisfied participants are with the results and how natural their faces look after treatment. Since its approval by the US Food and Drug Administration in 2002 for glabellar wrinkles, botulinum toxin (BTX) has been widely used to correct facial wrinkles.

Who is the study for?

This trial is for adults with moderate to severe upper facial lines, including frown lines between the eyebrows (glabellar), crow's feet (lateral canthal), and forehead wrinkles. Participants must be able to assess their wrinkles without glasses, though contacts are fine.

What is being tested?

The study tests participant satisfaction with BOTOX Cosmetic injections for treating upper facial lines. It's an open-label study where around 100 participants at various sites in the US and Canada will receive BOTOX injections and attend regular check-ups.

What are the potential side effects?

Possible side effects of BOTOX may include pain at the injection site, headache, flu-like symptoms, droopy eyelids or eyebrows, eye dryness or excessive tearing. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have moderate to severe frown, crow's feet, and forehead lines.

Select...

I can see well enough without glasses to notice wrinkles on my face.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 30

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 30

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 30 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants with Responder Status of 'Mostly satisfied' or 'Very satisfied' on the Facial Line Satisfaction Questionnaire (FLSQ) Follow Up Item 4 (Satisfaction with the Natural Look)

Secondary study objectives

Change From Baseline in Overall Score of the Participant's Assessment of FACE-Q Psychological Function

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: BOTOXExperimental Treatment1 Intervention

Participants will receive injections in the glabellar complex, in each of the lateral canthal area, and in the frontalis muscle on Day 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BOTOX

2013

Completed Phase 4

~1410

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Botulinum Toxin (BOTOX Cosmetic) treats wrinkles by selectively weakening specific muscles responsible for facial expressions. This is done through intramuscular injections that block nerve signals to the targeted muscles, preventing them from contracting. This reduction in muscle activity smooths out dynamic wrinkles, such as glabellar lines, lateral canthal lines, and forehead lines, which are caused by repeated facial movements. This mechanism is important for patients to understand as it helps set realistic expectations about the treatment's effectiveness, duration, and potential side effects, as well as the need for repeat treatments to maintain results.