BOTOX for Wrinkles

(UFL BOND 974 Trial)

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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the drug BOTOX Cosmetic for treating wrinkles?

Research shows that injections of botulinum toxin, like BOTOX Cosmetic, are highly demanded for aesthetic treatments and generally meet patients' expectations, with satisfaction levels varying depending on the type of wrinkles treated. For example, static forehead wrinkles had an effectiveness score of 91.67%, while dynamic forehead wrinkles scored 76.67%, indicating that the treatment is effective but results can vary. ^{1 2 3 4 5}

Is BOTOX safe for treating wrinkles?

BOTOX is generally considered safe for treating wrinkles, with most side effects being mild and temporary, such as mild pain at the injection site, headache, or flu-like symptoms. Serious or long-term side effects are rare, and any uncommon reactions, like an allergic response, can be managed effectively by healthcare professionals. ^{6 7 8 9 10}

How does the drug BOTOX Cosmetic differ from other treatments for wrinkles?

BOTOX Cosmetic is unique because it uses botulinum toxin type A to temporarily relax muscles, reducing the appearance of wrinkles, especially in the upper face. Unlike topical treatments, BOTOX is injected directly into the muscles, providing more effective results for wrinkle reduction. ^{11 12 13 14 15}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Innovative approach to aesthetical medicine services quality assessment. [2021]

2. New Zealand pubmed.ncbi.nlm.nih.gov

IncobotulinumtoxinA use in aesthetic indications in daily practice: a European multicenter, noninterventional, retrospective study. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Subject satisfaction with onabotulinumtoxinA treatment of glabellar and lateral canthal lines using a new patient-reported outcome measure. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Patient-reported benefit and satisfaction with botulinum toxin type A treatment of moderate to severe glabellar rhytides: results from a prospective open-label study. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Outcomes research in facial plastic surgery: a review and new directions. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse Events Associated With Botox as Reported in a Food and Drug Administration Database. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Complications with the use of botulinum toxin type A for cosmetic applications and hyperhidrosis. [2010]

8. England pubmed.ncbi.nlm.nih.gov

Report of Allergic Reaction After Application of Botulinum Toxin. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Complications of botulinum toxin A use in facial rejuvenation. [2017]

10. France pubmed.ncbi.nlm.nih.gov

[Prevention and management of locoregional complications of botulinum A toxin injections in cosmetic treatment]. [2010]

11. England pubmed.ncbi.nlm.nih.gov

Italian consensus report on the aesthetic use of onabotulinum toxin A. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Prospective randomized controlled study to determine the effect of topical application of botulinum toxin A for crow's feet after treatment with ablative fractional CO2 laser. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Indications and limitations for the use of botulinum toxin for the treatment of facial wrinkles. [2022]

14. Canada pubmed.ncbi.nlm.nih.gov

Botulinum toxin products overview. [2013]

15. United States pubmed.ncbi.nlm.nih.gov

Aesthetic botulinum A toxin in the mid and lower face and neck. [2019]