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| Name | Class |
|---|---|
| Novoxel Ltd. | INDUSTRY |
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To demonstrate the safety and performance of the Tixel fractional system for treatment of photodamage using low-energy settings.
A Prospective, single-center, single-arm clinical study of subjects who are seeking a procedure to reduce the appearance of photodamage, and meet study eligibility criteria, and have provided informed consent will be enrolled in the study. One investigational center will participate in the recruitment. Each study subject will receive 3 treatments with Tixel at 4-6 week intervals. Final follow-up will occur 3 months following the last treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tixel treatment arm | Experimental | subjects will receive 3 monthly treatments with the Tixel device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tixel | Device | Subjects will receive 3 monthly treatments with the Tixel device to treat the signs of photodamage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blinded photo evaluation | blinded observer rating of photos for photo damage using the Fitzpatrick Wrinkle Classification Scale: Class Description Score Description I Fine wrinkles 1-3 Mild: Fine texture changes with subtly accentuated skin lines. II Fine to moderate depth wrinkles, Moderate number of lines 4-6 Moderate: Distinct papular elastosis (individual papules with yellow translucency under direct lighting) and dyschromia III Fine to deep wrinkles, numerous lines, with or without redundant skin folds 7-9 Severe: Multipapular and confluent elastosis (thickened, yellow, and pallid) approaching or consistent with cutis rhomboidalis. | 3 months post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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:
Any subject who has 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, premalignant or malignant lesion 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 face):
Subjects who have used, within 30 days, any medication 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, such as amiodarone, clofazimine, or chloroquine.
Subjects currently taking or have taken an oral retinoid in the past six months; Subjects currently taking long-term oral corticosteroid 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.
Any other cause per the principal investigator's discretion.
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| Name | Affiliation | Role |
|---|---|---|
| Eric F. Bernstein, MD | Main Line Center for Laser Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Main Line Center for Laser Surgery | Ardmore | Pennsylvania | 19003 | United States |
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Treatment of subjects with a device for facial rejuvenation and blinded comparison of pre- and post-treatment photos.
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Photos will be evaluated in randomized blinded pairs pre- and post-treatment
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