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

October 27, 2025 updated by: Kachiu Lee, MD, Main Line Center for Laser Surgery

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Ardmore, Pennsylvania, United States, 19107
        • Main Line Center for Laser Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective change in Periocular Fine Lines and Wrinkles by Canfield Visia Imaging Analysis
Time Frame: From baseline (Week 0) to final follow-up visit (Week 8 ± 7 days after initial Tixel treatment).
Objective change in periocular fine lines and wrinkles will be measured using the Canfield Visia skin photography analysis system.
From baseline (Week 0) to final follow-up visit (Week 8 ± 7 days after initial Tixel treatment).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective change in Periocular Wrinkles and Texture by Dermatologist Assessment
Time Frame: From baseline (Week 0) to final follow-up visit (Week 8 ± 7 days after initial Tixel treatment).
A blinded, board-certified dermatologist will evaluate pre- and post-treatment photographs using a periocular wrinkle severity scale.
From baseline (Week 0) to final follow-up visit (Week 8 ± 7 days after initial Tixel treatment).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Main Line Center for Laser Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

June 13, 2025

First Submitted That Met QC Criteria

October 27, 2025

First Posted (Estimated)

October 29, 2025

Study Record Updates

Last Update Posted (Estimated)

October 29, 2025

Last Update Submitted That Met QC Criteria

October 27, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PTIOXTIXEL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Available upon request

IPD Sharing Time Frame

Data will be available for 7 years after the conclusion of the study.

IPD Sharing Access Criteria

Data will be available upon request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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