NCT03454672TerminatedNot Applicable
A Prospective, Randomized, Double Arm, Controlled Study With Blinded Assessment to Evaluate the Safety and Effectiveness of the Tixel Fractional System in the Treatment of Periorbital Wrinkles in Comparison With Fractional Laser
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Novoxel Ltd.
- Enrollment
- 68
- Locations
- 3
- Primary Endpoint
- Mean Change by Blinded Assessor Evaluation by Fitzpatrick Classification of Facial Wrinkling (FWCS) Scale
Study Overview
Brief Summary
This study is designed to explore the safety and the effectiveness of the Tixel device. This device performs fractional treatment of the skin by applying thermal (heat) energy to the skin. The study shall compare the safety and the effectiveness of the Tixel with the safety and the effectiveness of a laser device which is currently cleared for marketing in the US.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The assessor shall be blinded to the type of intervention when assessing the outcome of the treatment.
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male or female 40-70 years old diagnosed with clinically evident fine (mild) to moderate depth periorbital wrinkling
- •Willingness and ability to comply with all required study activities and protocol requirements.
- •The subject is able to provide written informed consent and perform the study's activities according to HIPAA guidelines and/or Israeli law, depending on each specific study site.
- •___________________________________________________________
Exclusion Criteria
- •The subject may not undergo treatment by the Tixel or comparator 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.
- •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 (Sun tan).
- •Subjects who have had the following treatments:
- •a prior cosmetic procedure to improve facial rhytides (i.e., rhytidectomy, periorbital or eyelid/eyebrow surgery, brow lift, CO2/Erbium/similar laser/fractional resurfacing, radiofrequency treatment) within 12 months
- •prior facial treatments with laser, surgical, chemical or light based facial treatments within the previous 6 months, such as for botulinum toxin injections, retinoid, microdermabrasion or prescription level glycolic acid treatments
- •Injectable filler in area to be treated within 9 months of investigation.
- •permanent facial implant
- •Any subject who have visible scars 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
- •Erythema with or without blistering
- •History of post inflammatory hyperpigmentation.
- •Active Acne Vulgaris, Herpes Simplex Virus (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.
- •Any skin pathology 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, or hypertrophic scarring
- •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 that can cause dermal hypersensitivity or affect skin characteristics (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, clofazinmine, minocycline or chloroquine.
- •Subjects currently taking or have taken an oral retinoid in the past six months (risk of scarring with therapy); Subjects currently taking long-term oral steroid treatment (causing fragility of the skin, risk of hematoma and bullae formation); Subjects taking Isotretinoin (Accutane or Roaccutan) within past 12 months.
- •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 surgery or overnight hospitalization during the study.
- •Enrollment in any active study involving the use of investigational devices or drugs.
- •Any other cause per the principal investigator's discretion.
Outcomes
Primary Outcomes
Mean Change by Blinded Assessor Evaluation by Fitzpatrick Classification of Facial Wrinkling (FWCS) Scale
Time Frame: baseline, 42 Weeks
The FWCS shall be assessed and quantified by 3 blinded assessors comparing baseline visit to +42 weeks visit.
Secondary Outcomes
- Mean Change of Subject Experience as Measured by Subject's Subjective Satisfaction Score(Treatment 1 (Baseline), Treatment 4 (Week 12), Treatment 5 (Week 16), Follow-up Visit 1 (Week 20), Follow-up Visit 3 (Week 42))
- Pain Level as Measured by the Visual Analog Scale (VAS) Scale(treatment 1 - treatment 5)
- Mean Score Performance as Measured by the Fitzpatrick Classification of Facial Wrinkling (FWCS)(baseline, 42 Weeks)
- Mean Score of Performance as Measured by 5-point Wrinkle Assessment Scale (WAS)(42 Weeks)
- Number of Days Reported by Subject Using Subjective Subject Downtime Assessment(visit 1 - visit 5)
- Number on End-User Experience Scale(After performing 5 treatments with each device. After performing between 20 or 30 treatments with each device. After completing all the required treatments in the investigator's study site with both devices.)
- Mean Improvement Performance as Measured by Improvement Global Assessment(visit 2, 3, 4, follow up 1, 2, 3)
Investigators
Study Sites (3)
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