Tixel for Wrinkles

Overseen By Jerome Garden, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Physicians Laser and Dermatology Institute

Must not be taking: Oral retinoids, Oral steroids

Disqualifiers: Pregnancy, Skin malignancy, Diabetes, others

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

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Tixel 2 can reduce the appearance of fine to moderate wrinkles around the eyes. Participants will receive up to four treatments, spaced four weeks apart, with follow-ups at one and three months after the final treatment. The trial seeks men and women aged 35 to 75 with noticeable wrinkles around their eyes who haven't recently undergone certain cosmetic treatments in that area. This opportunity is ideal for those wishing to enhance the appearance of their eye area without previous similar treatments. As an unphased trial, it offers a unique chance to explore innovative treatment options for improving the eye area.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using medications that affect the skin in the treatment area or have taken certain medications like oral retinoids or long-term oral steroids recently, you may need to stop or avoid them. It's best to discuss your specific medications with the trial team.

What prior data suggests that the Tixel 2 treatment is safe for reducing peri-orbital wrinkles?

Research has shown that Tixel 2 is generally safe for use. In earlier studies, participants reported only mild side effects, such as redness and swelling, which typically disappear within two days. Some experienced a dry or tight sensation, a normal part of the healing process.

No serious side effects were observed. Most participants expressed satisfaction with the treatment. The device's design ensures cleanliness and safety, reducing the risk of infection. Overall, Tixel 2 is well-tolerated and considered a safe option for reducing wrinkles around the eyes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for peri-orbital wrinkles, like Botox injections or laser therapy, Tixel 2 is unique because it uses a novel thermo-mechanical system to rejuvenate the skin. This method delivers controlled heat directly to the skin, promoting collagen production without the need for needles or intense laser beams. Researchers are excited about Tixel 2 because it offers a potentially more comfortable experience with minimal pain and downtime, making it an appealing option for those looking for effective wrinkle reduction with fewer side effects.

What evidence suggests that the Tixel 2 treatment is effective for reducing peri-orbital wrinkles?

Research has shown that Tixel 2, the treatment under study in this trial, effectively improves skin texture and reduces wrinkles. Studies have found it promising for rejuvenating facial skin, particularly for treating fine lines around the eyes. Tixel uses heat to target skin layers, refreshing and tightening the skin. Patients have reported significant improvements in wrinkles and overall skin texture. The treatment also addresses other skin issues like rosacea and acne. Overall, Tixel 2 has proven effective in various clinical settings for enhancing skin appearance. ^{1 3 6 7 8}

Who Is on the Research Team?

Jerome Garden, M.D.

Principal Investigator

Physician Laser & Dermatology Institute

Are You a Good Fit for This Trial?

Inclusion Criteria

Fitzpatrick wrinkle score of 3-7 in the peri-orbital areas per the treating investigator.

Stable body weight during the study period.

Skin Type I - V as per Fitzpatrick Skin Scale

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Treatment

Participants receive up to four treatments with Tixel every 4 weeks

12 weeks

4 visits (in-person), 1 phone-call visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Tixel 2

How Is the Trial Designed?

Group I: Tixel 2 Experimental Treatment 1 Intervention

Tixel 2 Treatment, 4 treatment sessions, followed by 2 Follow up sessions, 1 and 3 months after last treatment visit. Subject would be questioned about pain level, subjective downtime assessment and subjective response assessment. Images would be taken at the baseline and in Follow up visits.

Who Is Running the Clinical Trial?

Physicians Laser and Dermatology Institute

Lead Sponsor

Trials

1

Recruited

20+

Citations

1. 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10911265/

Comprehensive Review of Thermomechanical Fractional ... Tixel is a novel energy-based device with promising results for a variety of dermatologic conditions as demonstrated by the studies included in this review.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04639713

Clinical Study Evaluating the Safety and Effectiveness of ... Clinical Study Evaluating the Safety and Effectiveness of The Tixel Fractional System in The Treatment of Periorbital Wrinkles · Study Overview · Contacts and ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1367048422002946

The effect of non-ablative thermomechanical skin treatment ... In conclusion, Tixel treatment offered significant improvement in DED symptomatology, tear break up time, and most importantly improved tear homeostasis in this ...

5. novoxel.com novoxel.com/files/12-%20Fractional%20Treatment%20of%20Aging%20Skin%20with%20Tixel,%20a%20Clinical%20and%20Histological%20Evaluation-.pdf

Fractional treatment of aging skin with Tixel, a clinical and ... They are widely utilized in skin fractional skin resurfacing (2,3) for improved skin texture and fine wrinkles. Treatment is painful, requiring pre-application ...

6. consultingroom.com consultingroom.com/products/tixel/tixel-side-effects-what-you-need-to-know

Tixel Side Effects: What to Expect & How to Minimise Risks Expect mild, temporary side effects like redness, swelling, and a dry, tight feeling. These are normal and part of the healing process.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35412157/

Efficacy and safety of a thermal fractional skin rejuvenation ... No adverse effects were noted during treatment and follow-up. Most patients reported being "very satisfied" or "satisfied" with the treatment ...

8. novoxel.com novoxel.com/index.php?todo=treatment

what is the tixel® treatment? A safe, effective and non-invasive treatment with minimal side effects. There is no smoke, bleeding, fumes or carbonization.