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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare the efficacy and side effects of Botox and Jeuveau for glabellar lines.

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.

What data supports the effectiveness of the drug Onabotulinum toxin A and PrabotulinumtoxinA for treating frown lines?

Research shows that both Onabotulinum toxin A and PrabotulinumtoxinA are effective in improving the appearance of frown lines. Onabotulinum toxin A was the first approved treatment for facial lines, and PrabotulinumtoxinA has been shown to temporarily improve moderate-to-severe frown lines. ^{1 2 3 4 5}

Is Botox or Jeuveau safe for treating frown lines?

Both Botox (onabotulinumtoxinA) and Jeuveau (prabotulinumtoxinA) have been studied for safety in treating frown lines. Research shows they are generally safe with minimal side effects, and they are well tolerated by most people. ^{1 6 7 8 9}

How does the drug PrabotulinumtoxinA (Jeuveau) differ from other treatments for frown lines?

PrabotulinumtoxinA (Jeuveau) is unique because it is specifically approved for aesthetic use to temporarily improve moderate-to-severe frown lines, and it is a newer option compared to other botulinum toxin type A treatments like onabotulinumtoxinA (Botox). ^{1 2 3 4 10}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

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

PrabotulinumtoxinA-xvfs for the Treatment of Moderate-to-Severe Glabellar Lines. [2021]

2. New Zealand 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. [2021]

3. England 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. [2022]

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

Multicenter, randomized, phase III study of a single dose of incobotulinumtoxinA, free from complexing proteins, in the treatment of glabellar frown lines. [2014]

5. England pubmed.ncbi.nlm.nih.gov

The Efficacy and Duration of Onabotulinum Toxin A in Improving Upper Facial Expression Lines With 64-Unit Dose Optimization: A Systematic Review and Meta-Analysis With Trial Sequential Analysis of the Randomized Controlled Trials. [2023]

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

Pruritus associated with onabotulinumtoxinA treatment of neuromuscular pain. [2018]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Safety, efficacy, and onset of a novel botulinum toxin type A (Nabota) for the treatment of glabellar frown lines: a single-arm, prospective, phase 4 clinical study. [2020]

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

A Phase III Study of IncobotulinumtoxinA in the Treatment of Glabellar Frown Lines. [2021]

9. United States 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. [2022]

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

Treatment of glabellar frown lines with C. botulinum-A exotoxin. [2022]