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.

NCT05282979 | Unknown DMC FDA Device

• 1 other identifier: PLDI101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. Follow-up will occur 1 month and 3 months following last treatment.

Conditions

Wrinkle

Keywords

Periorbital

Outcome Measures

Primary Outcomes (2)

• Safety Adverse Events report

  Evaluation of related adverse events up to the 3-month after last treatment visit

  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.

  Up to 12 months

Secondary Outcomes (5)

• Effectiveness using Fitzpatrick Wrinkle Classification Scale (FWCS)- Unblinded

  Up to 12 months

• Effectiveness using GAIS-Global Aesthetic Improvement Scale Assessment-Unblinded

  Up to 12 months

• Evaluation of the pain and discomfort

  Up to 12 months

• Subject Subjective Downtime Assessment

  Up to 12 months

• Patients' Reported Outcomes

  Up to 12 months

Study Arms (1)

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.

Device: Tixel 2

Interventions

Tixel 2 DEVICE

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.

Tixel 2

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Physicians Laser and Dermatology Institute: lead

Study Sites (1)

Physicians Laser & Dermatology Institute, LLC

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (10)

• 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.

  PMID: 27746652 BACKGROUND

• Manriquez JJ, Majerson Gringberg D, Nicklas Diaz C. Wrinkles. BMJ Clin Evid. 2008 Dec 16;2008:1711.

  PMID: 19445782 BACKGROUND

• Gupta MA, Gupta AK. Photodamaged skin and quality of life; reasons for therapy. J Dermatol Treat 1996; 7:261-264

  BACKGROUND

• 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.

  PMID: 23467476 BACKGROUND

• Hruza 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.

  PMID: 19271373 BACKGROUND

• Mulholland 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

• 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.

  PMID: 25620090 BACKGROUND

• Fitzpatrick 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.

  PMID: 8629842 BACKGROUND

• Gold 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.

  PMID: 27474769 BACKGROUND

• Kim 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.

  PMID: 23252484 BACKGROUND

Related Links

• Causes of wrinkles and wrinkle prevention

Study Officials

• Jerome Garden, M.D.

  Physician Laser & Dermatology Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Calderon

CONTACT

3122800890; megan@pldilaser.com

Jerome Garden, M.D.

CONTACT

3122800890; j-garden@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Blinded assessed of the improvement would be done between Last FU images and baseline, following randomization of the images.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participates will undergo treatment with the Tixel 2 Device up to 4 treatments, 4 weeks apart and 2 Follow Up Visits

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 16, 2022
• Study Start: August 20, 2021
• Primary Completion: August 20, 2022
• Study Completion: August 20, 2022
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)