NCT07222176

Effects of P-TIOX and Tixel Combined on Reducing Eye Wrinkles

Synergistic Effects of P-TIOX and Tixel: A Split-Face, Prospective Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Main Line Center for Laser Surgery · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Accepted

Summary

This study looks at whether using a cosmeceutical called P-TIOX together with a treatment called Tixel can reduce fine lines and wrinkles around the eyes better than Tixel treatment alone. Tixel is an FDA-approved device that uses heat to improve skin texture and firmness. P-TIOX is a topical product with ingredients that may help improve the skin's appearance and elasticity. One side of the face will be treated with both P-TIOX and Tixel, while the other side will receive Tixel only. The study will last about 9 weeks and will include several treatments and evaluations using photos and expert assessments. Participants may notice improvement in the skin around their eyes. The results will help doctors understand if this combination treatment is more effective.

Detailed description

This clinical trial is designed to evaluate the combined effect of a topical cosmeceutical, P-TIOX, with fractional thermal treatment using the Tixel device, on improving fine lines and wrinkles around the eyes (periocular region). The study will compare the outcomes of this combination therapy to Tixel treatment alone using a split-face design, where one side of each participant's face receives both treatments and the other side receives only Tixel. Tixel is an FDA-cleared, fractional thermal-mechanical device that delivers controlled heat energy to the skin to stimulate collagen production and improve skin texture and elasticity. P-TIOX is an over-the-counter topical product containing a blend of peptides, acids, vitamins, and extracts that have been clinically shown to improve skin texture, elasticity, and the appearance of wrinkles. The study will enroll 20 adult participants aged 30 years or older who have mild to moderate periocular wrinkles. Participants will be randomized to apply P-TIOX daily on one side of the face starting one week before the first Tixel treatment and continuing for the duration of the 9-week study period. Both sides will receive three standardized Tixel treatments spaced over four weeks. Clinical outcomes will be assessed objectively by standardized photography using the Canfield Visia imaging system and analyzed by a blinded board-certified dermatologist using validated wrinkle severity scales. Subjective outcomes will be measured through patient self-assessment questionnaires. Safety will be monitored through adverse event reporting throughout the study. This study aims to determine if combining P-TIOX with Tixel treatment provides superior improvement in periocular fine lines and wrinkles compared to Tixel alone, offering a potentially enhanced minimally invasive treatment option for facial rejuvenation.

Conditions

• Periocular Fine Wrinkles

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Split-Face Tixel Treatment With and Without Topical Peptide-Based Cosmeceutical (P-TIOX)	This intervention involves applying a topical peptide-based cosmeceutical (P-TIOX) daily to one periocular area, combined with fractional thermal-mechanical treatment using the Tixel device on both sides of the face. The Tixel treatment delivers controlled heat energy to stimulate collagen remodeling and improve skin texture. One side of the face receives both P-TIOX and Tixel treatment, while the opposite side receives Tixel treatment alone, allowing comparison of the synergistic effects of the combination versus Tixel monotherapy.

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2025-10-29
• Last updated: 2025-10-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study