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

20 Participants Needed

Trial Summary

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 makes the drug DaxibotulinumtoxinA unique for aging treatment?

DaxibotulinumtoxinA, also known as Daxxify, is unique because it is a long-lasting botulinum toxin treatment, which means it may require fewer injections over time compared to other similar treatments. This can be more convenient for patients seeking to reduce signs of aging. ^{1 2 3 4 5}

What is the purpose of this trial?

This study seeks to evaluate the effectiveness and duration of action of DaxibotulinumtoxinA for neck rejuvenation through treatment of platysmal bands. This study will consist of one treatment visit with subjects being randomized to receiving 15 or 20 units of DaxibotulinumtoxinA per platysmal band. Subjects will return for 5 follow-up visits at 8, 12, 16, 20, and 24 weeks for evaluation.

Research Team

Kachiu Lee, MD

Principal Investigator

Physician

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Age-dependent enhancement of diazepam sensitivity is accelerated in New Zealand Black mice. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Aging reduces the mRNA of alpha 1 GABAA receptor subunit in rat cerebral cortex. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Aging related alterations in GABAA receptor subunit mRNA levels in Fischer rats. [2019]

4. Brazil pubmed.ncbi.nlm.nih.gov

Age effects on the pharmacokinetics of tityustoxin from Tityus serrulatus scorpion venom in rats. [2022]

5. Switzerland 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. [2020]