P-TIOX + Tixel for Crow's Feet

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Main Line Center for Laser Surgery

Must not be taking: Topical retinoids

Disqualifiers: Pregnant, Breastfeeding, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining a topical product called P-TIOX with a treatment called Tixel can reduce fine lines and wrinkles around the eyes more effectively than Tixel alone. Tixel uses heat to enhance the skin's appearance and texture, while P-TIOX is a cream that may increase skin elasticity and smoothness. Participants will receive treatment with both P-TIOX and Tixel on one side of their face, and only Tixel on the other side. Individuals with noticeable fine lines around their eyes who are willing to discontinue other skin treatments may be suitable candidates. The study will last about 9 weeks and includes several treatments and check-ups. As an unphased trial, this study provides a unique opportunity to explore innovative treatments for improving skin appearance.

Do I have to stop taking my current medications for the trial?

You will need to stop using other topical skincare products or retinoids around your eyes while participating in the study. The trial does not specify if you need to stop any other medications.

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

Studies have shown that Tixel is safe for treating wrinkles around the eyes. The FDA has approved it for this use, indicating its safety. Some research suggests that Tixel is well-tolerated, meaning people usually don't experience adverse reactions.

P-TIOX is a cream containing small proteins called peptides that aim to improve skin texture and reduce wrinkles. Although detailed safety information is limited, it is designed to be similar to other anti-wrinkle products generally considered safe.

Overall, both Tixel and P-TIOX appear well-tolerated based on available information. However, only a healthcare provider can offer advice tailored to individual needs. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this treatment for crow's feet because it combines the Tixel device and P-TIOX in a novel way. Tixel uses a fractional thermal-mechanical approach to stimulate collagen remodeling, which can improve skin texture and reduce wrinkles. P-TIOX adds a unique twist with its blend of peptides and active ingredients that aim to boost skin elasticity and smooth fine lines. By pairing these two, the treatment potentially offers a more effective solution for reducing crow's feet than current options like Botox or laser therapy, which primarily focus on muscle relaxation or skin resurfacing.

What evidence suggests that this trial's treatments could be effective for reducing crow's feet?

Research has shown that Tixel effectively improves skin texture and reduces wrinkles, particularly around the eyes. In one study, 95.9% of participants experienced more than a 51% improvement in their skin's appearance on the Global Aesthetic Improvement Scale. The FDA has also approved Tixel for treating wrinkles around the eyes.

In this trial, participants will receive Tixel treatment on both sides of their face, with one side also receiving the topical P-TIOX. The combination of P-TIOX and Tixel remains under study. P-TIOX is a cream containing ingredients that enhance skin elasticity and reduce fine lines. The aim is to determine if using it with Tixel yields better results. Although more research is needed, this combination might offer greater improvement than using Tixel alone. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals with crow's feet who want to reduce eye wrinkles. Participants should be willing to undergo split-face treatments over a 9-week period, where one side of the face receives Tixel and P-TIOX, while the other gets only Tixel.

Inclusion Criteria

Willingness to comply with study visits

Willingness to discontinue use of other topical cosmeceuticals/retinoids to the periocular region for the duration of the study

My eye area has moderate to severe issues.

Exclusion Criteria

Pregnant or breastfeeding

Known hypersensitivity to any component of P-TIOX

I have skin or eye problems in the area being treated.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive Tixel treatments and apply P-TIOX on one side of the face for 9 weeks

9 weeks

3 visits (in-person) at baseline, week 2, and week 4

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• P-TIOX
• Tixel

Trial Overview The study tests if combining a topical peptide-based cosmeceutical (P-TIOX) with Tixel treatment is more effective at reducing eye wrinkles than using Tixel alone. The effects will be measured through photos and expert assessments.

How Is the Trial Designed?

Group I: Tixel Treatment With and Without Adjunctive P-TIOX in a Split-Face Design Experimental Treatment 1 Intervention

This arm involves a split-face treatment design where one side of the participant's periocular area receives a combination therapy of Tixel and topical P-TIOX, while the contralateral side receives Tixel treatment alone without any topical intervention. Tixel is a fractional thermal-mechanical device used to stimulate collagen remodeling and improve skin texture. P-TIOX is a topical cosmeceutical containing peptides and other active ingredients aimed at enhancing skin elasticity and reducing fine lines. Participants apply P-TIOX once daily to the designated side starting seven days prior to the first Tixel treatment and continuing for the duration of the 9-week study. Both sides receive standardized Tixel treatments at baseline, week 2, and week 4. The objective is to evaluate whether the addition of P-TIOX provides superior improvement in periocular fine lines and wrinkles compared to Tixel alone.

Who Is Running the Clinical Trial?

Main Line Center for Laser Surgery

Lead Sponsor

Trials

4

Recruited

80+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07222176

Effects of P-TIOX and Tixel Combined on Reducing Eye ... This study aims to determine if combining P-TIOX with Tixel treatment provides superior improvement in periocular fine lines and wrinkles ...

2. withpower.com withpower.com/trial/phase-periocular-fine-wrinkles-5-2025-73c96

P-TIOX + Tixel for Crow's Feet · Info for Participants This study looks at whether using a cosmeceutical called P-TIOX together with a treatment called Tixel can reduce fine lines and wrinkles ...

3. crstodayeurope.com crstodayeurope.com/articles/2020-june/tixel-for-crows-feet-wrinkles-and-dry-eye-disease/

Tixel for Crow's Feet, Wrinkles, and Dry Eye Disease Published clinical study results show Tixel's ability to rejuvenate facial skin 1 and treat rosacea, active acne, hemangioma, hypertrophic scars, and more.

4. dermatologytimes.com dermatologytimes.com/view/newly-approved-device-improves-periorbital-wrinkles-with-minimal-down-time

Newly Approved Device Improves Periorbital Wrinkles With ... Tixel by Sentient received US Food and Drug Administration (FDA) approval for treatment of periorbital wrinkles, the company recently announced.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38170976/

Long-Term Improvement of Crow's Feet Wrinkles in ... Long-Term Improvement of Crow's Feet Wrinkles in Combination With Cervicofacial and Temporal Lifting: Review of the Literature.

6. skinceuticals.com skinceuticals.com/skincare/anti-aging-serum/p-tiox-anti-wrinkle-serum/S123.html

P-TIOX Anti-Wrinkle Serum P-TIOX is a peptide-powered serum inspired by the effects of anti-wrinkle neurotoxin injections, proven to reduce the appearance of 9 types of expression lines.

7. dermstore.com dermstore.com/p/skinceuticals-p-tiox-serum-30ml/15386550/?srsltid=AfmBOopO7zaBuJ3kQlsZQUcAGYJRsDgRvHb-A9uOvBPAhhtHYz8Br6eI

SkinCeuticals P-TIOX Anti-Wrinkle Peptide Serum (1 fl. oz.) The product appears to be an effective anti-aging serum that can improve skin texture, radiance, and the appearance of fine lines and wrinkles.

8. marmurmedical.com marmurmedical.com/wp-content/uploads/2024/10/Can-SkinCeuticals-P-Tiox-Serum-Replace-My-Botox-Treatments-Allure.pdf

Can This Smoothing Serum Replace Botox Treatments? SkinCeuticals P-Tiox is a new, peptide-based serum that's meant to reduce texture and the same pesky expression lines that Botox targets.

9. vogue.com vogue.com/article/skinceuticals-p-tiox-review

SkinCeuticals P-Tiox Serum Review SkinCeuticals P-Tiox Serum is a peptide serum that targets fine lines and wrinkles caused by facial expressions. Read one tester's review ...

10. docteurfiller.com docteurfiller.com/en/produit/skinceuticals-p-tiox-30ml-bottle/

SKINCEUTICALS P-TIOX | 30ml Bottle Reduced expression lines: Peptides in the formula help relax muscle contractions, diminishing the appearance of wrinkles on the forehead, around the eyes and ...