Periocular Fine WrinklesNCT07222176
Effects of P-TIOX and Tixel Combined on Reducing Eye Wrinkles
A study testing Split-Face Tixel Treatment With and Without Topical Peptide-Based Cosmeceutical (P-TIOX) in people with Periocular Fine Wrinkles, run by Main Line Center for Laser Surgery at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periocular Fine Wrinkles
- What is being tested?
- Split-Face Tixel Treatment With and Without Topical Peptide-Based Cosmeceutical (P-TIOX)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Main Line Center for Laser Surgery
Ardmore, Pennsylvania, 19107
About this study
Official title: 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.
Read the 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
- Being tested
- Split-Face Tixel Treatment With and Without Topical Peptide-Based Cosmeceutical (P-TIOX)
- Keywords
- Periocular fine wrinkles, periocular rhytides, periocular rejuventation, tixel, skinceuticals, P-TIOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: Split-Face Tixel Treatment With and Without Topical Peptide-Based Cosmeceutical (P-TIOX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
A blinded, board-certified dermatologist will evaluate pre- and post-treatment photographs using a periocular wrinkle severity scale.
Measured: From baseline (Week 0) to final follow-up visit (Week 8 ± 7 days after initial Tixel treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2025
- Study start1 Jun 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Periocular Fine WrinklesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Main Line Center for Laser Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kachiu Lee, MD, Main Line Center for Laser Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222176
- Sponsor's protocol ID
- PTIOXTIXEL
- Status last verified
- Oct 2025
- First submitted
- 13 Jun 2025
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Available upon request
Publications
Bollela VR. Mind the gap! Med Educ. 2008 May;42(5):519. doi: 10.1111/j.1365-2923.2008.03073.x. No abstract available.
PubMed 18412894Sajwan 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.
PubMed 36870212Chou 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.
PubMed 33134896Roy 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.
PubMed 37428009
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synergistic Effects of P-TIOX and Tixel: A Split-Face, Prospective Study
- ClinicalTrials.gov ID
- NCT07222176
- Acronym / sponsor ID
- PTIOXTIXEL
- Conditions
- Periocular Fine Wrinkles
- Keywords
- Periocular fine wrinkles, periocular rhytides, periocular rejuventation, tixel, skinceuticals, P-TIOX
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Main Line Center for Laser SurgeryUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 29 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tixel Treatment With and Without Adjunctive P-TIOX in a Split-Face Design | Experimental | Combination Product: Split-Face Tixel Treatment With and Without Topical Peptide-Based Cosmeceutical (P-TIOX)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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Combination product | Tixel Treatment With and Without Adjunctive P-TIOX in a Split-Face Design |
Primary outcome
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.
1 secondary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Background: PubMed 18412894Bollela VR. Mind the gap! Med Educ. 2008 May;42(5):519. doi: 10.1111/j.1365-2923.2008.03073.x. No abstract available.
- Background: PubMed 36870212Sajwan 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.
- Background: PubMed 33134896Chou 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.
- Background: PubMed 37428009Roy 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.
- Individual participant dataSharing planned: Yes. Available upon request
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Split-Face Tixel Treatment With and Without Topical Peptide-Based Cosmeceutical (P-TIOX) in people with Periocular Fine Wrinkles, run by Main Line Center for Laser Surgery at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07222176, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.