BOTOX for Wrinkles

(UFL BOND 974 Trial)

No longer recruiting at 9 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: AbbVie

Disqualifiers: Medical condition risk, Tattoos, 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 BOTOX Cosmetic for its effectiveness in treating noticeable upper facial lines, such as frown lines, crow's feet, and forehead wrinkles. The main goal is to assess participant satisfaction and the natural appearance of the results. All participants will receive BOTOX injections in their facial lines and attend regular check-ups to monitor effects and provide feedback on their satisfaction. Suitable candidates have moderate to severe facial lines and can see their wrinkles clearly without glasses (contacts are acceptable). As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective BOTOX benefits more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What is the safety track record for this treatment?

Research shows that BOTOX Cosmetic is generally safe and well-tolerated. Studies have found that at the recommended dose for treating frown lines and crow's feet, the treatment usually remains at the injection site, indicating good safety.

In past studies, common side effects included temporary headaches and slight bruising at the injection site. However, these effects were mild and typically resolved on their own. Botox has been used for years to treat facial lines, and this experience supports its safety. Participants in this trial can expect similar outcomes based on previous safety data. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

BOTOX Cosmetic is unique because it targets wrinkles with precision by relaxing specific muscles in the face, such as the glabellar complex, lateral canthal area, and frontalis muscle. Unlike many topical treatments that work on the skin's surface, BOTOX works by temporarily blocking nerve signals to muscles, reducing their activity and smoothing out wrinkles. Researchers are excited about its potential to deliver noticeable results quickly and with a relatively simple injection procedure compared to more invasive cosmetic surgeries.

What is the effectiveness track record for BOTOX Cosmetic in treating upper facial lines?

Research has shown that BOTOX Cosmetic, which participants in this trial will receive, effectively reduces facial lines, such as frown lines, crow's feet, and forehead lines. It blocks a chemical that causes muscle contraction, relaxing the muscles responsible for these lines. Many patients have noticed a clear reduction in these lines, and this treatment has proven effective for over 20 years. Clinical reviews consistently find that BOTOX reduces facial lines in various areas of the face. Overall, BOTOX Cosmetic is considered a reliable option for treating wrinkles caused by repeated facial expressions. ^{5 6 7 8 9}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

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

Exclusion Criteria

Presence of tattoos, jewelry, or clothing which obscures or interferes with the target area of interest and cannot be removed

History of known immunization or hypersensitivity to any botulinum toxin serotype

I have a condition that may make BOTOX Cosmetic risky for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BOTOX Cosmetic as intramuscular injections to the glabellar lines, lateral canthal lines, and forehead lines at Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment through medical assessments and questionnaires

4 weeks

Regular visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• BOTOX Cosmetic

Trial Overview 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.

How Is the Trial Designed?

Group I: BOTOX Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

Botulinum toxin, specifically Chinese botulinum toxin serotype A (CBTX-A), is generally safe for cosmetic procedures, but there is a risk of allergic reactions, as demonstrated in a case involving a 44-year-old woman who developed urticarial plaques shortly after treatment.

The allergic reaction was confirmed by a positive skin test and managed effectively with antihistamines and corticosteroids, highlighting the importance of monitoring for adverse events even in commonly used treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Report of Allergic Reaction After Application of Botulinum Toxin. Careta, MF., Delgado, L., Patriota, R.[2016]

Citations

1. 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5414775/

Duration of Clinical Efficacy of OnabotulinumtoxinA in ... Botulinum toxin Type A was first shown to reduce the appearance of facial lines more than 20 years ago. Since then, the number of botulinum toxin procedures ...

3. medrxiv.org medrxiv.org/content/10.1101/2025.05.14.25327581v1.full.pdf

Efficacy of Botulinum Toxin Type A in Reducing Facial ... Methods: This review examines clinical outcomes across various facial areas, including glabellar lines, crow's feet, and forehead lines, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01189760

Safety and Efficacy Study of Botulinum Toxin Type A for the ... This study will evaluate the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of Crow's Feet Lines and Frown Lines ...

5. mednexus.org mednexus.org/doi/10.1097/JD9.0000000000000368

A Single-Center Retrospective Clinical Study in Vietnam Conclusion: Botulinum toxin type A injection is an effective treatment for crow's feet. Adding a fourth injection maintains the same therapeutic ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2018/103000s5306lbl.pdf

This label may not be the latest approved by FDA. For current ... Spread of Toxin Effect. Postmarketing safety data from BOTOX Cosmetic and other approved botulinum toxins suggest that botulinum toxin effects may, in some ...

7. rxabbvie.com rxabbvie.com/pdf/botox-cosmetic_pi.pdf

HIGHLIGHTS OF PRESCRIBING INFORMATION Spread of Toxin Effect. Postmarketing safety data from BOTOX Cosmetic and other approved botulinum toxins suggest that botulinum toxin effects may, in some ...

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

Safety and tolerability of onabotulinumtoxinA in ... ... Botox Glabellar Lines II Study Group Double-blind, placebo-controlled study of the safety and efficacy of botulinum toxin type A for patients with glabellar ...

9. botoxcosmetic.com botoxcosmetic.com/

BOTOX® (onabotulinumtoxinA) - Official BOTOX® Cosmetic Site 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 ...