Microtox for Skin Aging

Overseen By Kalpna K Durairaj, MD

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Kalpna Kay Durairaj, MD, FACS

Must not be taking: NSAIDs, Neuromuscular drugs

Disqualifiers: Pregnancy, Autoimmune, Neuromuscular, others

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 explores a new treatment called microtox to determine its effects on facial skin quality, fine wrinkles, and texture. Participants will receive treatments on their foreheads, allowing researchers to compare the effects of two different neuromodulators: IncobotulinumtoxinA (Xeomin) and PrabotulinumtoxinA-Xvfs (Jeuveau). The study involves taking progress photos at three different times. This trial may suit biological females aged 18 to 65 with mild to moderate facial wrinkles who have not recently undergone cosmetic procedures. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Do I need to stop my current medications to join the trial?

The trial requires you to stop using medications that affect neuromuscular function or skin healing at least 2 weeks before starting. Other medications are not specified, so check with the trial team.

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

Research has shown that prabotulinumtoxinA-xvfs is generally safe for treating frown lines between the eyebrows. One study found that a single dose of 20 units was both safe and effective. However, some individuals reported dry eyes and less frequent blinking. Other possible side effects include muscle weakness and vision problems.

For incobotulinumtoxinA, studies indicate it is also safe for treating frown lines and has been well-tolerated over long-term use. Some participants experienced mild side effects, but these were uncommon.

Both treatments have been tested in many individuals, and serious side effects are rare. If there are any concerns, discussing them with the trial staff can provide more information about these treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for skin aging because they involve the use of botulinum toxins, which are well-known for their ability to smooth out wrinkles. Unlike other treatments that might require multiple sessions, prabotulinumtoxinA-xvfs and incobotulinumtoxinA offer the potential for noticeable results with just one treatment session. Also, the study explores how different toxins can be used on opposite sides of the face, providing insights into their effectiveness and potential side effects. This dual approach might help personalize treatments, making them more effective and tailored to individual needs.

What evidence suggests that this trial's treatments could be effective for skin aging?

Research has shown that prabotulinumtoxinA-xvfs holds promise for improving facial lines. In U.S. studies, 68% to 70% of patients noticed significant improvement in frown lines after 30 days. Another study suggested it can work as well as Botox for moderate-to-severe facial lines. In this trial, one group will receive prabotulinumtoxinA-xvfs and a placebo, while another group will receive prabotulinumtoxinA-xvfs and incobotulinumtoxinA. Similarly, incobotulinumtoxinA has proven very effective. Almost all patients in studies saw improved facial lines within 30 days, with results lasting up to 180 days. Both treatments have consistently reduced facial wrinkles and enhanced skin appearance. ^{6 7 8 9 10}

Who Is on the Research Team?

Kalpna K Durairaj, MD

Principal Investigator

K. Kay Durairaj, MD, A Medical Corp.

Are You a Good Fit for This Trial?

This trial is for individuals with facial wrinkles and signs of skin aging. Participants will be treated on one side of their forehead with a neuromodulator and the other side with either saline solution or a different brand of neuromodulator.

Inclusion Criteria

All skin types (Fitzpatrick I-VI)

Individuals with mild to moderate facial wrinkles

Willingness to participate and provide written informed consent

Exclusion Criteria

Known neuromuscular disorders or a hypersensitivity to botulinum toxin

Subject has a condition or is in a situation which, in the opinion of the Investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with participation in the study

I have serious skin conditions affecting my face.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one treatment session with prabotulinumtoxinA-xvfs and either placebo or incobotulinumtoxinA

1 day

1 visit (in-person)

Assessment

Participants have live assessment visits to evaluate treatment efficacy and satisfaction

12 weeks

2 visits (in-person) at weeks 2 and 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• IncobotulinumtoxinA
• PrabotulinumtoxinA-Xvfs

Trial Overview

The study tests microtox's effectiveness in improving facial skin quality, fine wrinkles, and texture by comparing two groups: one receiving a placebo on one forehead side and the other receiving two different neuromodulators on each side.

How Is the Trial Designed?

Group I: Treated with prabotulinumtoxinA-xvfs and incobotulinumtoxinA Active Control 2 Interventions

Subjects will have one treatment session at week 0 and two live assessment visits at weeks 2 and 12. Approximately 20 units of prabotulinumtoxinA-xvfs will be injected into the left side of the subject's glabellar lines and forehead region, and approximately 20 units of incobotulinumtoxinA will be injected into the right side of the subject's glabellar lines and forehead region.

Group II: Treated with prabotulinumtoxinA-xvfs and placebo Placebo Group 2 Interventions

Subjects will have one treatment session at week 0 and two live assessment visits at weeks 2 and 12. Approximately 20 units of prabotulinumtoxinA-xvfs will be injected into the left side of the subject's glabellar lines and forehead region, and a placebo saline treatment will be injected into the right side of the subject's glabellar lines and forehead region.

IncobotulinumtoxinA is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Xeomin for:

• Blepharospasm
• Cervical dystonia
• Facial wrinkles

Approved in United States as Xeomin for:

• Blepharospasm
• Cervical dystonia
• Facial wrinkles
• Upper limb spasticity

Approved in Canada as Xeomin for:

• Blepharospasm
• Cervical dystonia
• Facial wrinkles

Approved in Japan as Xeomin for:

• Blepharospasm
• Cervical dystonia

Who Is Running the Clinical Trial?

Kalpna Kay Durairaj, MD, FACS

Lead Sponsor

Trials

2

Recruited

50+

Evolus, Inc.

Industry Sponsor

Trials

9

Recruited

2,500+

Published Research Related to This Trial

The development of an internal Threshold of Toxicological Concern (iTTC) aims to provide safer exposure limits for chemicals based on their plasma concentration, enhancing risk assessments for human safety.

A collaborative workshop involving stakeholders from various sectors evaluated the current science and strategies needed to establish iTTCs, addressing challenges and outlining next steps for this ambitious project.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges in working towards an internal threshold of toxicological concern (iTTC) for use in the safety assessment of cosmetics: Discussions from the Cosmetics Europe iTTC Working Group workshop. Ellison, CA., Blackburn, KL., Carmichael, PL., et al.[2023]

The study found significant inconsistencies in the toxicological evaluations of dermal exposure to five chemicals used in cosmetics, indicating a need for improved regulatory assessments.

No systematic differences were observed in the hazard assessments for these substances, suggesting that current frameworks may not adequately address the safety of dermal exposure in consumers and workers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative analysis of toxicological evaluations for dermal exposure performed under two different EU regulatory frameworks. Westerholm, E., Schenk, L.[2014]

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]

The review emphasizes the importance of assessing inhalation exposure to cosmetic spray products, as traditional safety assessments primarily focus on dermal contact, which may overlook potential inhalation risks.

It proposes a standardized approach for risk assessment of cosmetic sprays, aiming to unify safety evaluation methodologies across the industry while allowing flexibility for individual assessors, which can benefit both large companies and small to medium enterprises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Special aspects of cosmetic spray safety evaluations: principles on inhalation risk assessment. Rothe, H., Fautz, R., Gerber, E., et al.[2011]

In a study involving 102 subjects with blepharospasm, repeated injections of incobotulinumtoxinA demonstrated sustained efficacy, significantly improving symptoms over a period of up to 69 weeks with flexible dosing and injection intervals.

The treatment was generally safe, with common side effects being eyelid ptosis (31.4%) and dry eye symptoms (17.6%), but no new safety risks were identified, and no subjects developed neutralizing antibodies during the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained efficacy and safety of repeated incobotulinumtoxinA (Xeomin(®)) injections in blepharospasm. Truong, DD., Gollomp, SM., Jankovic, J., et al.[2021]

IncobotulinumtoxinA is a unique botulinum toxin type A that is free from complexing proteins, which may contribute to its safety and efficacy in various therapeutic applications.

Clinical trials have demonstrated that incobotulinumtoxinA is effective and safe for treating glabellar frown lines, leading to its widespread approval in aesthetic medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IncobotulinumtoxinA in esthetics. Kerscher, M., Yutskovskaya, Y., Flynn, TC.[2014]

In a study of 25 women aged 35-65, incobotulinumtoxinA was found to be highly effective for treating platysmal bands, achieving a 100% response rate at Day 14 and maintaining a 96% response rate at Day 84.

The treatment was well-tolerated with mild and reversible side effects, and a significant majority of participants reported high satisfaction with the results, indicating that the effects persisted for up to 3 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of IncobotulinumtoxinA for the treatment of platysmal bands of the aging neck: an open-label, prospective pilot study. Gubanova, EI., Panova, OS., Sanchez, EA., et al.[2015]

A study involving 15 patients compared the effects of onabotulinumtoxinA and prabotulinumtoxinA-xvfs on forehead and glabella wrinkles, finding no significant differences in onset of action or patient satisfaction between the two treatments.

Both formulations of botulinum toxin A were equally effective in reducing dynamic wrinkles, although there was a slight trend suggesting that patients may prefer onabotulinumtoxinA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OnabotulinumtoxinA versus PrabotulinumtoxinA-xvfs: A Randomized, Triple-blind, Split-face Study on the Time to Onset, Rhytid Appearance, and Patient Satisfaction in Forehead and Glabellar Lines. Vasile, G., Green, C., Bhatti, H., et al.[2023]

A study evaluated the skin irritation potential of 60 cosmetic products marketed in Turkey from 2015-2017 using the EpiDerm in vitro 3D human skin model, revealing that most hair care products were either moderate or mild irritants, with only one shampoo classified as a strong irritant.

The findings support the ongoing use of alternative in vitro tests for assessing the safety of both cosmetic ingredients and final products, especially since animal testing for cosmetics has been prohibited since 2013.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of skin irritation potentials of different cosmetic products in Turkish market by reconstructed human epidermis model. Kose, O., Erkekoglu, P., Sabuncuoglu, S., et al.[2018]

IncobotulinumtoxinA effectively reduces lateral periorbital lines in women aged 40 to 50, with significant improvements observed at one and three months after treatment, regardless of the dilution used.

Both dilutions of incobotulinumtoxinA showed similar efficacy and tolerability, indicating that the choice of dilution does not impact the treatment's effectiveness for reducing wrinkles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Lateral Periorbital Lines with Different Dilutions of IncobotulinumtoxinA. Muti, GF., Basso, M.[2020]

Incobotulinumtoxin-A is a cost-effective treatment for blepharospasm and cervical dystonia compared to onabotulinumtoxin-A, with incremental costs per quality-adjusted life-year of A$ 25,588 and A$ 23,794, respectively, based on a 5-year Markov model analysis.

The flexible treatment intervals for incobotulinumtoxin-A allow for better symptom management, resulting in patients experiencing fewer weeks of symptoms compared to the fixed 12-week intervals required for onabotulinumtoxin-A.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness of Incobotulinumtoxin-A with Flexible Treatment Intervals Compared to Onabotulinumtoxin-A in the Management of Blepharospasm and Cervical Dystonia. Tilden, D., Guarnieri, C.[2018]

A pilot project to collect reports of undesirable effects (UEs) from cosmetic products revealed that dermatologists were the primary reporters, submitting 47 out of 76 total reports, highlighting the need for better reporting systems in cosmetovigilance.

The majority of reported UEs were cutaneous reactions, with allergic contact dermatitis and irritant contact dermatitis being the most common diagnoses, indicating that facial and body care products are significant contributors to these adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Notification of undesirable effects of cosmetics and toiletries. Sportiello, L., Cammarota, S., de Portu, S., et al.[2015]

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