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

NCT07222176 | Active Not Recruiting FDA Device

• 1 other identifier: PTIOXTIXEL
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Periocular Fine Wrinkles

Keywords

Periocular fine wrinkles; periocular rhytides; periocular rejuventation; tixel; skinceuticals; P-TIOX

Outcome Measures

Primary Outcomes (1)

• Objective change in Periocular Fine Lines and Wrinkles by Canfield Visia Imaging Analysis

  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 Outcomes (1)

• Subjective change in Periocular Wrinkles and Texture by Dermatologist Assessment

  From baseline (Week 0) to final follow-up visit (Week 8 ± 7 days after initial Tixel treatment).

Study Arms (1)

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

EXPERIMENTAL

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)

Interventions

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

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

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Main Line Center for Laser Surgery: lead

Study Sites (1)

Main Line Center for Laser Surgery

Ardmore, Pennsylvania, 19107, United States

Location

Related Publications (4)

• Bollela VR. Mind the gap! Med Educ. 2008 May;42(5):519. doi: 10.1111/j.1365-2923.2008.03073.x. No abstract available.

  PMID: 18412894 BACKGROUND

• Sajwan RK, Solanki PR. Gold@Carbon Quantum Dots Nanocomposites Based Two-In-One Sensor: A Novel Approach for Sensitive Detection of Aminoglycosides Antibiotics in Food Samples. Food Chem. 2023 Jul 30;415:135590. doi: 10.1016/j.foodchem.2023.135590. Epub 2023 Feb 3.

  PMID: 36870212 BACKGROUND

• Chou P, Wang GH, Hsueh SW, Yang YC, Kuo CC. Delta-Frequency Augmentation and Synchronization in Seizure Discharges and Telencephalic Transmission. iScience. 2020 Oct 9;23(11):101666. doi: 10.1016/j.isci.2020.101666. eCollection 2020 Nov 20.

  PMID: 33134896 BACKGROUND

• Roy JM, Kazim SF, Rumalla K, Schmidt MH, Bowers CA. Geographic trends in the utilization of frailty as a preoperative decision-making tool in neurosurgery. J Neurosurg Sci. 2023 Dec;67(6):774-775. doi: 10.23736/S0390-5616.23.06104-0. Epub 2023 Jul 10. No abstract available.

  PMID: 37428009 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: This study utilizes a split-face, prospective, within-subject controlled design to evaluate the synergistic effects of P-TIOX combined with Tixel treatment on periocular fine lines and wrinkles. Each participant serves as their own control. One side of the face is randomly assigned to receive daily topical application of P-TIOX in addition to standardized Tixel treatments, while the contralateral side receives Tixel treatment alone without any topical intervention. This paired design allows direct comparison of treatment efficacy within the same individual, minimizing variability due to intrinsic patient factors such as skin type, lifestyle, and genetic background. Objective assessments using standardized imaging and blinded evaluator grading, as well as subjective patient self-assessments, are performed to evaluate differences in wrinkle severity and skin texture improvements between the two treatment sides over a 9-week study period.

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: October 29, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available for 7 years after the conclusion of the study.
• Access Criteria: Data will be available upon request.

Locations

US (1)