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

20 Participants Needed

Trial Summary

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.

What data supports the idea that Microtox for Skin Aging is an effective drug?

The available research shows that Microtox, specifically IncobotulinumtoxinA, is effective in treating skin aging signs like crow's feet. In a study, participants who received the drug showed a noticeable improvement in their wrinkle scores after one and three months. The scores improved by about 2 points on a scale, indicating a significant reduction in wrinkles. This suggests that Microtox is effective in reducing the appearance of wrinkles, making it a viable option for skin aging treatment. ^{1 2 3 4 5}

What safety data exists for Microtox for Skin Aging?

The provided research does not contain specific safety data for Microtox or its related names (IncobotulinumtoxinA, Xeomin, PrabotulinumtoxinA-Xvfs, Jeuveau). The studies focus on general cosmetic safety assessments, skin irritation potentials, and regulatory frameworks for cosmetics, but do not address the safety of botulinum toxin products specifically. ^{6 7 8 9 10}

Is the drug IncobotulinumtoxinA, also known as Xeomin or Jeuveau, a promising treatment for skin aging?

Yes, IncobotulinumtoxinA is a promising treatment for skin aging. It is effective and well-tolerated for reducing facial wrinkles, including glabellar frown lines and crow's feet. It has been approved for aesthetic use and has shown positive results in clinical trials. ^{1 3 4 11 12}

What is the purpose of this trial?

The goal of this split-face clinical trial is to test the efficacy of microtox in improving facial skin quality, fine wrinkles, and texture. Participants will: * be randomly assigned to Group A (which will receive 20 units of neuromodulator on the left side of the forehead and a placebo saline treatment on the right side) or Group B (which will receive 20 units of neuromodulator on the left side of the forehead and 20 units of a different neuromodulator brand on the right side as a comparator) * have one treatment session at week 0, and two live assessment visits at weeks 2 and 12 * have their pictures taken at each visit to track progress

Research Team

Kalpna K Durairaj, MD

Principal Investigator

K. Kay Durairaj, MD, A Medical Corp.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Treatment of Lateral Periorbital Lines with Different Dilutions of IncobotulinumtoxinA. [2020]

2. United States 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. [2023]

3. United States 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. [2015]

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

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

5. Austria pubmed.ncbi.nlm.nih.gov

Sustained efficacy and safety of repeated incobotulinumtoxinA (Xeomin(®)) injections in blepharospasm. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of skin irritation potentials of different cosmetic products in Turkish market by reconstructed human epidermis model. [2018]

7. Netherlands 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. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Notification of undesirable effects of cosmetics and toiletries. [2015]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Comparative analysis of toxicological evaluations for dermal exposure performed under two different EU regulatory frameworks. [2014]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Special aspects of cosmetic spray safety evaluations: principles on inhalation risk assessment. [2011]

11. United States 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. [2018]

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

IncobotulinumtoxinA in esthetics. [2014]