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The purpose of this investigation is to evaluate the safety and efficacy of the Cutera excel V Laser Genesis procedure utilizing the 1064nm laser for skin rejuvenation.
This is a single-center prospective, open-label uncontrolled study in 15 male or female subjects, age 35 to 55 years who desire non-ablative laser treatment for facial photo-rejuvenation, specifically improvement of rhytides, lentigines, erythema, telangiectasia and skin texture. Subjects will receive laser treatments and complete a follow up visit 12 weeks post-final treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Excel V laser | Other | excel V Laser Genesis procedure utilizing 1064 nm laser |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| excel V Laser | Device | excel V Laser Genesis procedure utilizing 1064 nm laser |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Improvement Rating at 12 Weeks Post-final Treatment | The degree of improvement from Baseline observed in the post-treatment photographs at 12 weeks as assessed by independent blinded Reviewers using the Physician's Global Assessment of Improvement Scale (GAIS) Higher scores indicate better outcomes
| 12 weeks post-final treatment |
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Inclusion Criteria:
Exclusion Criteria:
Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
Any type of prior cosmetic treatment to the target area within 6 months of study participation, such as laser or light-based procedures or surgery.
Prior injection to the face of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler within 6 months of study participation, as applicable.
Systemic use of retinoid, such as isotretinoin, or corticosteroid, as applicable, within 6 months of study participation.
Use of topical medications on the face, such as antibiotics, benzoyl peroxide, retinoids (isotretinoin), corticosteroids, hydroquinone, or products containing dihydroxyacetone or alpha-hydroxy with concentration > 8%, within 1 month of participation.
History of malignant tumors in the target area.
Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles.
Pregnant and/or breastfeeding.
Having an infection, dermatitis or a rash in the treatment area.
Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
Suffering from coagulation disorders, or taking prescription anticoagulation medication which might make study participation unsafe according to Investigator's discretion.
History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
History of vitiligo, eczema, or psoriasis.
History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
History of seizure disorders due to light.
Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen.
History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
Current smoker or history of smoking within 6 months of study participation.
As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin Laser and Surgery Specialists of NY and NJ | New York | New York | 10022 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Excel V Laser | Treatment with the excel V Laser Genesis procedure utilizing 1064 nm laser |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Excel V Laser | Treatment with the excel V Laser Genesis procedure utilizing 1064 nm laser |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Degree of Improvement Rating at 12 Weeks Post-final Treatment | The degree of improvement from Baseline observed in the post-treatment photographs at 12 weeks as assessed by independent blinded Reviewers using the Physician's Global Assessment of Improvement Scale (GAIS) Higher scores indicate better outcomes
| Posted | Mean | Standard Deviation | score on a scale | 12 weeks post-final treatment |
|
|
12 weeks post-final treatment, up to 9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Excel V Laser | Treatment with the excel V Laser Genesis procedure utilizing 1064 nm laser |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margot Doucette | Cutera | 415-656-9612 | mdoucette@cutera.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 22, 2016 | Aug 10, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010859 | Pigmentation Disorders |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Participants |
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 16 |
| 16 |
| Edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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