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

NCT ID: NCT07222176

Last Updated: 2025-10-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2027-06-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tixel Treatment With and Without Adjunctive P-TIOX in a Split-Face Design

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.

Group Type: EXPERIMENTAL

Split-Face Tixel Treatment With and Without Topical Peptide-Based Cosmeceutical (P-TIOX)

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• Severity of 2, 3, or 4 based on the 5-point severity scale of both periocular areas
• 30 years of age or older
• 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

Exclusion Criteria

• Pregnant or breastfeeding
• Prior treatment with periocular laser, energy-based devices, neuromodulators, or dermal fillers within the past six months
• Prior surgical intervention in the periocular region within the past twelve months
• Use of topical retinoids in the periocular area within the past four weeks
• Known hypersensitivity to any component of P-TIOX
• Presence of active dermatologic or ocular disease in the treatment area
• Active systemic infection
• Active cold sore/herpes labialis infection

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Main Line Center for Laser Surgery

OTHER

Sponsor Role: lead

Responsible Party

Kachiu Lee, MD

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Main Line Center for Laser Surgery

Ardmore, Pennsylvania, United States

Countries

United States

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Other Identifiers

PTIOXTIXEL

Identifier Type: -

Identifier Source: org_study_id