DaxibotulinumtoxinA for Aging

Overseen By Jessica Plugis

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Main Line Center for Laser Surgery

Disqualifiers: Pregnancy, Connective tissue disorder, Dysphagia, 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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of DaxibotulinumtoxinA, a botulinum toxin injection, for smoothing and rejuvenating the neck by targeting platysmal bands (muscle bands in the neck). Participants will receive either 15 or 20 units of this treatment and will have check-ups over several months to assess its effectiveness and duration. Ideal participants are those over 30 who notice visible neck bands and have not received similar treatments in the past 6 months. As a Phase 4 trial, this research aims to understand how this already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have used botulinum toxin in your neck in the past 6 months, you cannot participate.

What is the safety track record for DaxibotulinumtoxinA?

A previous study found that 17.8% of participants experienced mild side effects from DaxibotulinumtoxinA, with no serious side effects linked to the treatment. This suggests it is generally safe. The FDA has already approved the treatment for improving facial lines, which adds confidence about its safety. However, there is a note that the effects might spread and cause serious symptoms in rare cases. Overall, the treatment has been well-tolerated, but it's important to be aware of any possible risks. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about DaxibotulinumtoxinA for aging because it offers a potentially longer-lasting effect compared to traditional botulinum toxin treatments like Botox or Dysport. While most treatments for reducing wrinkles and fine lines work by temporarily paralyzing muscles to smooth skin, DaxibotulinumtoxinA is designed to have a longer duration of action, which means fewer treatment sessions might be needed. This could be particularly beneficial for those seeking a more convenient treatment schedule without compromising on effectiveness.

What is the effectiveness track record for DaxibotulinumtoxinA in neck rejuvenation?

Research has shown that DaxibotulinumtoxinA effectively reduces wrinkles and lines and lasts longer than other treatments. This trial will compare two dosages of DaxibotulinumtoxinA: 20 units and 15 units. Studies have found that DaxibotulinumtoxinA lasts longer than onabotulinumtoxinA, a common type of botulinum toxin. Patients often notice improvements as soon as two days after treatment, with many seeing clear results by the fourth week. Most people require fewer injection appointments because its effects last longer. Clinical data supports its safety and effectiveness, making it a reliable choice for cosmetic enhancements. ^{4 5 6 7 8}

Who Is on the Research Team?

Kachiu Lee, MD

Principal Investigator

Physician

Are You a Good Fit for This Trial?

This trial is for individuals over 30 years old who want to improve the appearance of their neck by reducing platysmal bands, which are signs of aging. Participants must have a moderate to severe rating on the Merz Neck Scale and haven't used any botulinum toxin in their neck for at least six months. Pregnant individuals or those with certain medical conditions like connective tissue disorders, neuromuscular issues, or active infections in the treatment area cannot join.

Inclusion Criteria

I haven't used botulinum toxin in my neck in the last 6 months.

Rating of 2, 3, or 4 on 5-point Merz Neck Scale

I am over 30 years old.

Exclusion Criteria

I have a connective tissue disorder.

I have a history of swallowing difficulties or muscle control disorders.

I have an infection in the area that would be treated.

Timeline for a Trial Participant

Screening/Treatment

Participants are screened for eligibility to participate in the trial and receive treatment with DaxibotulinumtoxinA

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

5 visits (in-person) at 8, 12, 16, 20, and 24 weeks

Evaluation

A blinded independent evaluator assesses baseline and post-treatment photographs on Merz Neck Scale

What Are the Treatments Tested in This Trial?

Interventions

• DaxibotulinumtoxinA

Trial Overview The study tests DaxibotulinumtoxinA's effectiveness in rejuvenating the neck by treating platysmal bands. Participants will be randomly assigned to receive either 15 or 20 units per band during one treatment visit and will return for follow-ups over a period of up to 24 weeks.

How Is the Trial Designed?

Group I: DaxibotulinumtoxinA 20 units Experimental Treatment 1 Intervention

Subjects will receive 20 units of daxibotulinumtoxinA per platysmal band, up to 2 anterior bands and 2 lateral bands.

Group II: DaxibotulinumtoxinA 15 units Experimental Treatment 1 Intervention

Subjects will receive 15 units of daxibotulinumtoxinA per platysmal band, up to 2 anterior bands and 2 lateral bands.

DaxibotulinumtoxinA is already approved in United States for the following indications:

Approved in United States as Daxxify for:

• Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
• Treatment of cervical dystonia

Who Is Running the Clinical Trial?

Main Line Center for Laser Surgery

Lead Sponsor

Trials

4

Recruited

80+

Published Research Related to This Trial

The study investigates how age-related factors influence the pharmacokinetics of lamotrigine, a medication used to treat epilepsy, which is crucial for understanding how to optimize dosing for different age groups.

Findings suggest that older patients may require dose adjustments due to changes in drug metabolism and clearance, highlighting the importance of personalized treatment plans for effective epilepsy management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correction to: Effect of Age-Related Factors on the Pharmacokinetics of Lamotrigine and Potential Implications for Maintenance Dose Optimisation in Future Clinical Trials. van Dijkman, SC., de Jager, NCB., Rauwé, WM., et al.[2020]

In aged male Fischer F-344 rats, there was a significant reduction in the binding of ligands to the GABAA receptor in the cerebral cortex, indicating potential changes in receptor function due to aging.

The study found an 86% decrease in alpha 1 mRNA levels in the cerebral cortex of aged rats, suggesting that aging leads to selective structural changes in GABAA receptors, while levels in the cerebellum remained unchanged.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aging reduces the mRNA of alpha 1 GABAA receptor subunit in rat cerebral cortex. Mhatre, MC., Fernandes, G., Ticku, MK.[2019]

In aged male Fischer F-344 rats, there was a significant reduction in the binding of ligands to picrotoxin binding sites, indicating a decrease in the density of these binding sites rather than changes in their affinity.

The study found a notable decrease (about 70%) in alpha 1 mRNA levels in the cerebral cortex of older rats, suggesting that aging selectively affects the composition of GABAA receptors, which may impact GABAergic signaling in the brain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aging related alterations in GABAA receptor subunit mRNA levels in Fischer rats. Mhatre, MC., Ticku, MK.[2019]

The study found that young rats (21-22 days old) had significantly higher peak plasma concentrations (Cmax) and area under the curve (AUC) for tityustoxin compared to adult rats (150-160 days old), indicating that age affects how the toxin is absorbed and distributed in the body.

These pharmacokinetic differences suggest that children may experience more severe symptoms from scorpion envenomation than adults, as the toxin behaves differently in younger individuals, which could help explain the higher incidence of severe cases in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Age effects on the pharmacokinetics of tityustoxin from Tityus serrulatus scorpion venom in rats. Nunan, EA., Arya, V., Hochhaus, G., et al.[2022]

C57BL/6 and autoimmune NZB mice both showed a decrease in the effective dose (ED50) for diazepam-induced ataxia as they aged, but NZB mice experienced a significantly greater decrease between 3 and 12 months, indicating increased sensitivity to benzodiazepines with age.

In contrast, both mouse strains exhibited similar increases in the duration of loss of righting reflex from barbiturates, suggesting that the age-related sensitivity changes are specific to benzodiazepines and not applicable to barbiturates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Age-dependent enhancement of diazepam sensitivity is accelerated in New Zealand Black mice. Forster, MJ., Retz, KC., Popper, MD., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7752211/

Efficacy Results From SAKURA 3, a Large, Open-Label ... DaxibotulinumtoxinA for Injection 40U demonstrated a significantly longer duration of response than onabotulinumtoxinA 20U in subjects with moderate or severe ...

2. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2022/761127Orig1s000MultidisciplineR.pdf

761127Orig1s000 - accessdata.fda.gov The efficacy and safety of DAXXIFY was established following the review of clinical data during the first review cycle. The Applicant provided ...

3. academic.oup.com academic.oup.com/asj/article/43/2/205/6695383

Efficacy and Safety of DaxibotulinumtoxinA for Injection in the ... DAXI demonstrated a high response rate and extended duration of effect across age and race subgroups that was consistent with the overall study population. As ...

4. americanboardcosmeticsurgery.org americanboardcosmeticsurgery.org/news/daxxify-new-botox-alternative/

What to Know About DAXXIFY, the New BOTOX Alternative Patients will likely enjoy the longer-lasting effects of DAXXIFY and the time savings resulting from needing fewer injection appointments to ...

5. daxxify.com daxxify.com/

Long-lasting Frown Line Treatment - DAXXIFY® *In clinical trial diaries, patients reported seeing a measurable improvement within 2 days of treatment. 74% achieved a ≥ 2-grade improvement at week 4 per ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7752221/

A Focus on Safety From the SAKURA 3 Study The study found that 17.8% of subjects had mild, treatment-related adverse events, with no serious treatment-related adverse events, confirming the safety of ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/761127s000lbl.pdf

HIGHLIGHTS OF PRESCRIBING INFORMATION These ... DAXXIFY is for temporary improvement of glabellar lines, but its effects may spread, causing life-threatening symptoms. It is not for other conditions.

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK594233/

DaxibotulinumtoxinA-Ianm - StatPearls - NCBI Bookshelf - NIH This activity reviews the adverse event profile, off-label uses, dosing, monitoring recommendations, and relevant interactions of this ...