UnknownNot Applicable

Evaluating the Safety and Effectiveness of the Tixel Fractional System in the Treatment of Photodamage at Low Settings

United States25 participantsStarted 2022-01-07

Plain-language summary

To demonstrate the safety and performance of the Tixel fractional system for treatment of photodamage using low-energy settings.

Age range25 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female 25-70 years old with clinically evident photodamage.
✓. 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 per the treating investigator and clinically noticeable wrinkles in the treating area.
✓. Skin Type I - V as per Fitzpatrick Skin Scale.

✕. 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.
✕. Subjects with significant exposure to critical amounts of ultraviolet light (Suntan).
✕. Subjects who have had the following treatments:
✕. a cosmetic procedure to improve rhytides (i.e. Carbon Dioxide/Erbium/similar laser/fractional resurfacing, radiofrequency treatment) within 3 months
✕. prior facial treatments with laser, surgical, chemical or light-based facial treatments within the previous 3 months, including botulinum toxin injections or microdermabrasion.

Blinded photo evaluation

Timeframe: 3 months post-treatment

NCT IDNCT05182502

SponsorEric Bernstein, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09

Who can participate

Age range25 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female 25-70 years old with clinically evident photodamage.
✓. 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 per the treating investigator and clinically noticeable wrinkles in the treating area.
✓. Skin Type I - V as per Fitzpatrick Skin Scale.

✕. 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.
✕. Subjects with significant exposure to critical amounts of ultraviolet light (Suntan).
✕. Subjects who have had the following treatments:
✕. a cosmetic procedure to improve rhytides (i.e. Carbon Dioxide/Erbium/similar laser/fractional resurfacing, radiofrequency treatment) within 3 months
✕. prior facial treatments with laser, surgical, chemical or light-based facial treatments within the previous 3 months, including botulinum toxin injections or microdermabrasion.