WrinkleNCT05282979
A Prospective, Single Center, Single-Arm Clinical Study of 20 Participants to Reduce the Appearance of the Peri-orbital Wrinkles. Participants Will Receive up to Four Treatments With Tixel Every 4 Weeks. Follow-up Will Occur 1 Month and 3 Months Following Last Treatment.
A study testing Tixel 2 in people with Wrinkle, run by Physicians Laser and Dermatology Institute at 1 site in United States.
Trial summary
A Prospective, Single center, Single-Arm Clinical Study of 13-20 study participants who are seeking a procedure to reduce the appearance of the peri-orbital wrinkles. Each study participant will receive up to four (4) treatments with the Tixel in a monthly interval. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkle
- What is being tested?
- Tixel 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2021to 20 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female 35-75 years old diagnosed with clinically evident fine (mild) to moderate depth periorbital wrinkles.
- Willingness and ability to comply with all required study activities including returning for follow-up visits and protocol requirements.
- The subject is able to provide written informed consent and perform the study's activities according to HIPAA guidelines.
- Fitzpatrick wrinkle score of 3-7 in the peri-orbital areas per the treating investigator.
- Stable body weight during the study period.
- Skin Type I - V as per Fitzpatrick Skin Scale
Who cannot join
- Past treatment with Tixel device.
- The subject may not undergo treatment by the Tixel device according to the device's contra-indications for use, as defined in the User Manual and in the Instructions for Use and by any other labeling of the device.
- Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
- Female subjects who are pregnant, or planning to become pregnant, or have given birth less than 3 months ago or are lactating.
- Subjects with significant exposure to critical amounts of ultraviolet light (Suntan).
- Subjects who have had the following treatments:
Show all 28Show fewer
- a cosmetic procedure to improve periorbital rhytides within 6 months.
- Injectable filler in temples and in the upper face area to be treated within 12 months of investigation.
- Any subject who have visible scars or other visible changes over the treated areas that may affect evaluation of response and/or quality of photography.
- Subjects with any type of active cut, wound, inflammation, lesion (benign, premalignant or malignant) or active bacterial, viral, fungal, or herpetic infection on the skin on the designated treatment sites or in close proximity to it.
- Existing or history of the following (when discussing skin conditions, refers only to the periorbital sites):
- skin malignancy, or any diagnosis of suspected malignancy
- Collagen or vascular or bleeding disease
- Immunosuppression or autoimmune disease
- History of persistent beyond 2 years post inflammatory hyperpigmentation.
- Active Acne Vulgaris, HSV-1, or any existing skin condition/disease that in the investigator's opinion would interfere with the evaluation of the safety of the study treatment and evaluation.
- Any skin condition which can induce bullous lesions, urticaria, or demonstrate a Koebner phenomenon (psoriasis, lichen planus, etc.).
- Any disease that inhibits pain sensation
- History of keloid formation.
- Conditions affecting healing rate (i.e. diabetes mellitus I or II, vascular condition, etc.)
- neuromuscular disorders
- Subjects who have used, within 30 days, any medication over the periorbital area that can cause dermal hypersensitivity or affect skin characteristics over the treated area (i.e. topically applied retinoids, hydroquinone, Chemical peel of any strength: glycolic acid, lactic acid, salicylic acid)
- Subjects who have used, systemic treatment which may induce dyspigmentation within 12 months, such as amiodarone, clofazinmine, minocycline or chloroquine.
- Subjects currently taking or have taken an oral retinoid in the past 6 months;Subjects currently taking long-term oral steroid treatment.
- Concurrent therapy that, in the principal investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study treatment.
- Subjects who anticipate the need for major surgery or overnight hospitalization during the study that can affect the study schedule or treatment evaluation.
- Enrollment in any active study involving the use of investigational devices or drugs which would impact the periorbital response.
- Any other cause per the principal investigator's discretion.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Physicians Laser & Dermatology Institute, LLC
Chicago, Illinois, 60611
Megan Calderon, 312-280-0890, megan@pldilaser.com
Jerome Garden, M.D.
About this study
Official title: A Prospective, Single-arm Clinical Study Evaluating the Safety and Effectiveness of the Tixel Fractional System in the Treatment of Periorbital Wrinkles
A Prospective, Single center, Single-Arm Clinical Study of 13-20 study participants who are seeking a procedure to reduce the appearance of the peri-orbital wrinkles. Each study participant will receive up to four (4) treatments with the Tixel in a monthly interval. Follow-up will occur 1 month and 3 months following last treatment.
Read the detailed description
A Prospective, Single center, Single-Arm Clinical Study of 13-20 participants who are seeking a procedure to reduce the appearance of the peri-orbital wrinkles, and meet study eligibility criteria, and have provided informed consent will be enrolled in the study. Each study participate will receive up to 4 treatments with Tixel in monthly interval. Follow-up will occur at 1 month and 3 months following the last visit.
The clinic visits will be as follow:
- Base line (1st tx)
- Phone-call visit (3 days after the first treatment)
- 4 week (2nd tx)
- 8 week (3rd tx)
- 12 week (4th tx)
- 4 weeks after the last treatment (1st Follow-up)
- 12 weeks after the last treatment (2nd follow-up = 3 months follow-up, primary endpoint and the study completion visit)
Primary Safety Endpoint is the evaluation of related adverse events up to the 3-month visit after treatment.
- Conditions
- Wrinkle
- Being tested
- Tixel 2
- Keywords
- Periorbital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tixel 2Device
Thermo-mechanical technology for fractional treatment of human skin. Dermal heating and coagulative effect that occur during the treatment session provide dermal remodeling and collagen restructuring that promote wrinkles appearance improvement.
| Study group | Role | What they receive |
|---|---|---|
| Tixel 2 | Experimental | Tixel 2 Treatment, 4 treatment sessions, followed by 2 Follow up sessions, 1 and 3 months after last treatment visit. Subject would be questioned about pain level, subjective downtime assessment and subjective response assessment. Images would be taken at the baseline and in Follow up visits. Receives: Device: Tixel 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Adverse Events report
Evaluation of related adverse events up to the 3-month after last treatment visit
Measured: Up to 12 months
Effectiveness using Fitzpatrick Wrinkle Classification Scale (FWCS)
Comparison of the proportion of subjects with a ≥ 1-score improvement on the Fitzpatrick Wrinkle Classification Scale (FWCS) at the 3-month visit compared to baseline. The FWCS is a clinically validated assessment tool used to assess skin wrinkle severity and elastosis on a scale from 1 through 9, where the lower score is considered better.
Measured: Up to 12 months
Secondary outcomes (5)
Effectiveness using Fitzpatrick Wrinkle Classification Scale (FWCS)- Unblinded
Assessment of improvement using Fitzpatrick Wrinkle Classification Scale (FWCS) at each visit compared to baseline by the handling physician. The FWCS is a clinically validated assessment tool used to assess skin wrinkle severity and elastosis on a scale from 1 through 9, where the lower score is considered better.
Measured: Up to 12 months
Effectiveness using GAIS-Global Aesthetic Improvement Scale Assessment-Unblinded
Assessment of improvement using Global Aesthetic Improvement Scale Assessment at 1 month and 3 month follow up compared to baseline by the handling physician. Rating:
- Exceptional improvement patient; 2) Very improved patient; 3) Improved patient; 4)Unaltered patient; 5) Worsened patient
Measured: Up to 12 months
Evaluation of the pain and discomfort
Evaluation of the pain and discomfort of the treatment as reported by the subject on a visual analog scale (VAS). Scoring will consist of making a mark on a 10-point scale. Each line will be awarded a score of 0-10 according to the level of pain when 0 is no pain and 10 is maximum pain possible.
Measured: Up to 12 months
Subject Subjective Downtime Assessment
Evaluation of the period of time following the procedure during which the subject felt unable/unwilling to go out in public.
Measured: Up to 12 months
Patients' Reported Outcomes
Subject Satisfaction Questionnaire and GAIS- Global Aesthetic Improvement Scale Assessment. Rating: 1) Exceptional improvement patient; 2) Very improved patient; 3) Improved patient; 4) Unaltered patient; 5) Worsened patient
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start20 Aug 2021
- Primary completion20 Aug 2022 (estimated)
- Study completion20 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for WrinkleStudies 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
- All participates will undergo treatment with the Tixel 2 Device up to 4 treatments, 4 weeks apart and 2 Follow Up Visits
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Physicians Laser and Dermatology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jerome Garden, M.D., Principal investigator, Physician Laser & Dermatology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282979
- Sponsor's protocol ID
- PLDI101
- Status last verified
- Mar 2022
- First submitted
- 15 Feb 2022
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Undecided
Publications
Park SE, Kim SS, Kim CW, Her Y. A Prospective Split-Face Comparative Study of Periorbital Wrinkle Treatments: Fractional Erbium-Doped Yttrium Aluminum Garnet Laser, Intense Pulsed Light, and Topical 0.1% Tretinoin Cream. Ann Dermatol. 2016 Oct;28(5):650-652. doi: 10.5021/ad.2016.28.5.650. Epub 2016 Sep 30. No abstract available.
PubMed 27746652Manriquez JJ, Majerson Gringberg D, Nicklas Diaz C. Wrinkles. BMJ Clin Evid. 2008 Dec 16;2008:1711.
PubMed 19445782Gupta MA, Gupta AK. Photodamaged skin and quality of life; reasons for therapy. J Dermatol Treat 1996; 7:261-264
Ganceviciene R, Liakou AI, Theodoridis A, Makrantonaki E, Zouboulis CC. Skin anti-aging strategies. Dermatoendocrinol. 2012 Jul 1;4(3):308-19. doi: 10.4161/derm.22804.
PubMed 23467476Hruza G, Taub AF, Collier SL, Mulholland SR. Skin rejuvenation and wrinkle reduction using a fractional radiofrequency system. J Drugs Dermatol. 2009 Mar;8(3):259-65.
PubMed 19271373Mulholland RS, Ahn DH, Kreindel M, Paul M. Fractional Ablative Radio-Frequency Resurfacing in Asian and Caucasian Skin: A Novel Method for Deep Radiofrequency Fractional Skin Rejuvenation. Journal of Cosmetics, Dermatological Sciences and Applications. 2012;2(3):144-150
Michaud T, Gassia V, Belhaouari L. Facial dynamics and emotional expressions in facial aging treatments. J Cosmet Dermatol. 2015 Mar;14(1):9-21. doi: 10.1111/jocd.12128. Epub 2015 Jan 24.
PubMed 25620090Fitzpatrick RE, Goldman MP, Satur NM, Tope WD. Pulsed carbon dioxide laser resurfacing of photo-aged facial skin. Arch Dermatol. 1996 Apr;132(4):395-402.
PubMed 8629842Gold AH, Pozner J, Weiss R. A Fractional Bipolar Radiofrequency Device Combined with a Bipolar Radiofrequency and Infrared Light Treatment for Improvement in Facial Wrinkles and Overall Skin Tone and Texture. Aesthet Surg J. 2016 Oct;36(9):1058-67. doi: 10.1093/asj/sjw086. Epub 2016 Jul 29.
PubMed 27474769Kim JK, Roh MR, Park GH, Kim YJ, Jeon IK, Chang SE. Fractionated microneedle radiofrequency for the treatment of periorbital wrinkles. J Dermatol. 2013 Mar;40(3):172-6. doi: 10.1111/1346-8138.12046. Epub 2012 Dec 17.
PubMed 23252484
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm Clinical Study Evaluating the Safety and Effectiveness of the Tixel Fractional System in the Treatment of Periorbital Wrinkles
- ClinicalTrials.gov ID
- NCT05282979
- Acronym / sponsor ID
- PLDI101
- Conditions
- Wrinkle
- Keywords
- Periorbital
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Physicians Laser and Dermatology InstituteUniversity, hospital or other
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 20 Aug 2022 (estimated)
- Study completion
- 20 Aug 2022 (estimated)
- First posted
- 16 Mar 2022 (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.
A Prospective, Single center, Single-Arm Clinical Study of 13-20 study participants who are seeking a procedure to reduce the appearance of the peri-orbital wrinkles. Each study participant will receive up to four (4) treatments with the Tixel in a monthly interval. Follow-up will occur 1 month and 3 months following last treatment.
Detailed description
A Prospective, Single center, Single-Arm Clinical Study of 13-20 participants who are seeking a procedure to reduce the appearance of the peri-orbital wrinkles, and meet study eligibility criteria, and have provided informed consent will be enrolled in the study. Each study participate will receive up to 4 treatments with Tixel in monthly interval. Follow-up will occur at 1 month and 3 months following the last visit.
The clinic visits will be as follow:
- Base line (1st tx)
- Phone-call visit (3 days after the first treatment)
- 4 week (2nd tx)
- 8 week (3rd tx)
- 12 week (4th tx)
- 4 weeks after the last treatment (1st Follow-up)
- 12 weeks after the last treatment (2nd follow-up = 3 months follow-up, primary endpoint and the study completion visit)
Primary Safety Endpoint is the evaluation of related adverse events up to the 3-month visit after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participates will undergo treatment with the Tixel 2 Device up to 4 treatments, 4 weeks apart and 2 Follow Up Visits
| Arm | Type | Receives |
|---|---|---|
| Tixel 2 | Experimental | Device: Tixel 2Tixel 2 Treatment, 4 treatment sessions, followed by 2 Follow up sessions, 1 and 3 months after last treatment visit. Subject would be questioned about pain level, subjective downtime assessment and subjective response assessment. Images would be taken at the baseline and in Follow up visits. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female 35-75 years old diagnosed with clinically evident fine (mild) to moderate depth periorbital wrinkles.
- Willingness and ability to comply with all required study activities including returning for follow-up visits and protocol requirements.
- The subject is able to provide written informed consent and perform the study's activities according to HIPAA guidelines.
- Fitzpatrick wrinkle score of 3-7 in the peri-orbital areas per the treating investigator.
- Stable body weight during the study period.
Key exclusion criteria (28 listed)
- Past treatment with Tixel device.
- The subject may not undergo treatment by the Tixel device according to the device's contra-indications for use, as defined in the User Manual and in the Instructions for Use and by any other labeling of the device.
- Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
- Female subjects who are pregnant, or planning to become pregnant, or have given birth less than 3 months ago or are lactating.
- Subjects with significant exposure to critical amounts of ultraviolet light (Suntan).
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 |
|---|---|---|
| Tixel 2Thermo-mechanical technology for fractional treatment of human skin. Dermal heating and coagulative effect that occur during the treatment session provide dermal remodeling and collagen restructuring that promote wrinkles appearance improvement. | Device | Tixel 2 |
Primary outcome
Safety Adverse Events report
Time frame: Up to 12 months
Evaluation of related adverse events up to the 3-month after last treatment visit
Effectiveness using Fitzpatrick Wrinkle Classification Scale (FWCS)
Time frame: Up to 12 months
Comparison of the proportion of subjects with a ≥ 1-score improvement on the Fitzpatrick Wrinkle Classification Scale (FWCS) at the 3-month visit compared to baseline. The FWCS is a clinically validated assessment tool used to assess skin wrinkle severity and elastosis on a scale from 1 through 9, where the lower score is considered better.
5 secondary outcomes
Effectiveness using Fitzpatrick Wrinkle Classification Scale (FWCS)- Unblinded
Time frame: Up to 12 months
Effectiveness using GAIS-Global Aesthetic Improvement Scale Assessment-Unblinded
Time frame: Up to 12 months
Evaluation of the pain and discomfort
Time frame: Up to 12 months
Subject Subjective Downtime Assessment
Time frame: Up to 12 months
Patients' Reported Outcomes
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Background: PubMed 27746652Park SE, Kim SS, Kim CW, Her Y. A Prospective Split-Face Comparative Study of Periorbital Wrinkle Treatments: Fractional Erbium-Doped Yttrium Aluminum Garnet Laser, Intense Pulsed Light, and Topical 0.1% Tretinoin Cream. Ann Dermatol. 2016 Oct;28(5):650-652. doi: 10.5021/ad.2016.28.5.650. Epub 2016 Sep 30. No abstract available.
- Background: PubMed 19445782Manriquez JJ, Majerson Gringberg D, Nicklas Diaz C. Wrinkles. BMJ Clin Evid. 2008 Dec 16;2008:1711.
- BackgroundGupta MA, Gupta AK. Photodamaged skin and quality of life; reasons for therapy. J Dermatol Treat 1996; 7:261-264
- Background: PubMed 23467476Ganceviciene R, Liakou AI, Theodoridis A, Makrantonaki E, Zouboulis CC. Skin anti-aging strategies. Dermatoendocrinol. 2012 Jul 1;4(3):308-19. doi: 10.4161/derm.22804.
- Background: PubMed 19271373Hruza G, Taub AF, Collier SL, Mulholland SR. Skin rejuvenation and wrinkle reduction using a fractional radiofrequency system. J Drugs Dermatol. 2009 Mar;8(3):259-65.
- BackgroundMulholland RS, Ahn DH, Kreindel M, Paul M. Fractional Ablative Radio-Frequency Resurfacing in Asian and Caucasian Skin: A Novel Method for Deep Radiofrequency Fractional Skin Rejuvenation. Journal of Cosmetics, Dermatological Sciences and Applications. 2012;2(3):144-150
- Background: PubMed 25620090Michaud T, Gassia V, Belhaouari L. Facial dynamics and emotional expressions in facial aging treatments. J Cosmet Dermatol. 2015 Mar;14(1):9-21. doi: 10.1111/jocd.12128. Epub 2015 Jan 24.
- Background: PubMed 8629842Fitzpatrick RE, Goldman MP, Satur NM, Tope WD. Pulsed carbon dioxide laser resurfacing of photo-aged facial skin. Arch Dermatol. 1996 Apr;132(4):395-402.
- Background: PubMed 27474769Gold AH, Pozner J, Weiss R. A Fractional Bipolar Radiofrequency Device Combined with a Bipolar Radiofrequency and Infrared Light Treatment for Improvement in Facial Wrinkles and Overall Skin Tone and Texture. Aesthet Surg J. 2016 Oct;36(9):1058-67. doi: 10.1093/asj/sjw086. Epub 2016 Jul 29.
- Background: PubMed 23252484Kim JK, Roh MR, Park GH, Kim YJ, Jeon IK, Chang SE. Fractionated microneedle radiofrequency for the treatment of periorbital wrinkles. J Dermatol. 2013 Mar;40(3):172-6. doi: 10.1111/1346-8138.12046. Epub 2012 Dec 17.
- Individual participant dataSharing planned: No. Undecided
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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.
Jerome Garden, M.D. principal investigator
Physician Laser & Dermatology Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tixel 2 in people with Wrinkle, run by Physicians Laser and Dermatology Institute 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 6 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 16 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Megan Calderon (3122800890, megan@pldilaser.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Adverse Events report (time frame: Up to 12 months). The study lists 2 primary outcomes in all. 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 NCT05282979, which also lists 10 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 16 Mar 2022.