Botox vs Jeuveau for Frown Lines

Overseen By Preeya Mehta

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Southern California

Disqualifiers: Cardiac patients, others

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

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare the effectiveness and side effects of Botox (Onabotulinum toxin A) and Jeuveau (PrabotulinumtoxinA) in reducing frown lines. Researchers will inject Botox on one side of the face and Jeuveau on the other to determine which works better. Individuals who have not received similar injections or surgery in the last 4 months and have no heart issues may be suitable candidates. Participants must be willing to attend follow-ups throughout the study. As an Early Phase 1 trial, this research seeks to understand how these treatments work in people, offering participants a chance to contribute to foundational knowledge.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are a cardiac patient, you cannot participate in the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found Botox to be safe and well-tolerated for treating frown lines between the eyebrows. At the recommended dose, it caused no serious side effects, remaining localized without unexpected problems.

Research has shown that Jeuveau is also safe for reducing frown lines. In studies, participants received a single dose, which proved effective without major issues. Although serious side effects like allergic reactions can occur, they remain rare.

The FDA has approved both treatments for improving frown lines, further supporting their safety. However, it is crucial to follow any instructions or warnings provided by the healthcare provider during the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Botox (Onabotulinum toxin A) and Jeuveau (PrabotulinumtoxinA) because they both offer innovative approaches to treating frown lines. Unlike most traditional treatments that may require longer-term usage to see visible effects, these botulinum toxin injections can deliver noticeable results quickly, often within days. Additionally, each treatment utilizes slightly different formulations of botulinum toxin, which might offer variations in effectiveness or duration of results. This potential for rapid improvement and the subtle differences in formulation have researchers eager to explore their full capabilities for skin rejuvenation.

What evidence suggests that this trial's treatments could be effective for frown lines?

In this trial, participants will receive either Botox, a type of onabotulinum toxin A, or Jeuveau, a prabotulinumtoxinA treatment, to compare their effectiveness in reducing frown lines. Research has shown that Botox can reduce frown lines by about 40% to 48%, with 87% of people noticing improvements in the lines between their eyebrows. Similarly, Jeuveau is effective, with one study showing that 58% of patients saw noticeable improvements in their frown lines after four months. Jeuveau can start working quickly, in as little as two days, and its effects may last up to four months. Both treatments significantly smooth frown lines for many people. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over the age of 18 who want to reduce frown lines and are willing to provide informed consent. It's not suitable for those who can't legally agree to participate in medical studies.

Inclusion Criteria

I am older than 18 years.

You want to take part in the study and can understand and agree to it by giving your permission.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive injections of Botox on one side of the face and Jeuveau on the other side for glabellar lines

1 day

1 visit (in-person)

Follow-up

Participants are monitored for efficacy and side effects, including movement reduction and side effects like bruising and pain

3 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Onabotulinum toxin A
• PrabotulinumtoxinA

Trial Overview

The study is testing two different botulinum toxin products, Botox (OnabotulinumtoxinA) and Jeuveau (PrabotulinumtoxinA), directly against each other on either side of the face to see which one works better at smoothing out glabellar lines.

How Is the Trial Designed?

Group I: Prabotulinumtoxin A Experimental Treatment 1 Intervention

8-10 units of Jeuveau will be injected in the glabellar lines in the other side of the face in 3 different locations. This injection will happen once.

Group II: Onabotulinumtoxin A Experimental Treatment 1 Intervention

8-10 units of Botox will be injected in the glabellar lines in one side of the face in 3 different locations. This injection will happen once.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Published Research Related to This Trial

In a Phase III trial involving 105 participants, incobotulinumtoxinA demonstrated high efficacy for treating moderate-to-severe glabellar frown lines, with 98.1% of subjects showing improvement at Day 28 and 80.0% at Day 84.

The treatment was well tolerated, with a low incidence of adverse events and no development of neutralizing antibodies, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase III Study of IncobotulinumtoxinA in the Treatment of Glabellar Frown Lines. Imhof, M., Kühne, U.[2021]

A meta-analysis of 1678 participants from multiple studies confirmed that onabotulinumtoxinA is safe and well-tolerated for treating facial lines, with no significant difference in overall adverse event incidence compared to placebo.

The most common treatment-related adverse events were mild to moderate, including eyelid sensory disorder and eyelid ptosis, but these were infrequent and decreased with repeated treatments, indicating a favorable long-term safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of onabotulinumtoxinA in the treatment of facial lines: a meta-analysis of individual patient data from global clinical registration studies in 1678 participants. Brin, MF., Boodhoo, TI., Pogoda, JM., et al.[2022]

PrabotulinumtoxinA-xvfs (Jeuveau) significantly improved the appearance of moderate-to-severe glabellar lines, with 67.5% to 70.4% of patients showing a greater than 2-point improvement on the Glabellar Line Scale compared to only 1.2% to 1.3% in placebo groups across two clinical trials.

The treatment was well tolerated, demonstrating safety, and showed greater efficacy than onabotulinumtoxinA, with 87.2% of patients achieving improvement compared to 82.8% for onabotulinumtoxinA and 4.2% for placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PrabotulinumtoxinA-xvfs for the Treatment of Moderate-to-Severe Glabellar Lines. Gadarowski, MB., Ghamrawi, RI., Taylor, SL., et al.[2021]

OnabotulinumtoxinA is generally considered safe and effective for both cosmetic and medical treatments, with minimal adverse events reported.

A case study is presented where a patient experienced neuropathic pruritus five days after receiving onabotulinumtoxinA for neuromuscular pain, emphasizing the need for awareness and management of this potential side effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pruritus associated with onabotulinumtoxinA treatment of neuromuscular pain. Ho, D., Jagdeo, J.[2018]

IncobotulinumtoxinA showed a faster onset of treatment effect for glabellar frown lines compared to onabotulinumtoxinA and abobotulinumtoxinA, with female subjects experiencing effects as early as 3.02 days after treatment.

The duration of the treatment effect was also longer for incobotulinumtoxinA than for the other two preparations, indicating it may provide more sustained results for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Onset and duration of effect of incobotulinumtoxinA, onabotulinumtoxinA, and abobotulinumtoxinA in the treatment of glabellar frown lines: a randomized, double-blind study. Rappl, T., Parvizi, D., Friedl, H., et al.[2021]

A study comparing incobotulinumtoxinA and a higher dose of onabotulinumtoxinA (30 U) found no significant difference in effectiveness for treating glabellar frown lines, confirming that the standard 20 U dose is sufficient.

The research involved subjects aged 18-65 with moderate-to-severe frown lines, and assessments showed that increasing the dose of onabotulinumtoxinA did not provide any additional benefits over incobotulinumtoxinA at multiple time points up to 6 months post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase IV study comparing incobotulinumtoxinA and onabotulinumtoxinA using a 1:1.5 dose-conversion ratio for the treatment of glabellar frown lines. Prager, W., Rappl, T.[2022]

Citations

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pmc.ncbi.nlm.nih.gov

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Botulinum Toxin Type A for Glabellar Frown Lines

The authors found that ABO 120 U was particularly effective at reducing the appearance of moderate (Grade 2) glabellar lines with a median ...

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healio.com

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Botulinum toxin A formulations offer varying outcomes for ...

In contrast, onabotulinum toxin A and incobotulinum toxin A caused reductions ranging from approximately 40% to 48%.

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e-aaps.org

e-aaps.org/upload/pdf/aaps-2024-01172.pdf

Comparing the efficacy, safety, and satisfaction for ...

Conclusions Overall, the abobotulinum toxin A group exhibited a higher improvement rate in the glabellar lines at the frown state. The ...

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mdpi.com

mdpi.com/2072-6651/17/4/160

Efficacy and Safety of a Newly Developed Botulinum Toxin ...

(FAS analysis) The glabellar line response rates were 87.42% (139/159) in the test group and 82.91% (131/158) in the control group (Figure 1), with no ...

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oamjms.eu

oamjms.eu/index.php/mjms/article/download/9834/7973/98966

Effectiveness and Efficiency of Prabotulinum Toxin-A ...

In 2002 the FDA approved BTX-A as a treatment for glabellar frown wrinkles [4], [5]. Prabotulinumtoxin A (PRA) is the newest Type A botulinum ...

6.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2011/103000s5236lbl.pdf

BOTOX (onabotulinumtoxinA) Label - accessdata.fda.gov

No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX/BOTOX. Cosmetic at the labeled dose of ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S2666328723001451

Safety and tolerability of onabotulinumtoxinA in the ...

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

8.

pmc.ncbi.nlm.nih.gov

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

The whole truth about botulinum toxin – a review - PMC

Treatment with botulinum toxin is widely viewed as safe, effective and largely devoid of serious side effects. There are two classes of Botox-related adverse ...

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BOTOX Cosmetic (onabotulinumtoxinA) for injection ...

The co-primary efficacy endpoints were the investigator's rating of glabellar line severity at maximum frown and the subject's global assessment of change in ...