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This is a prospective study of up to 30 subjects designed to assess the safety and effectiveness of a non-ablative fractional laser combination wavelength treatment for general resurfacing of photoaged skin. All study subjects will be treated on the whole face with the CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces. Subjects will be treated with a consecutive series of four (4) treatments spaced 1 month apart, along with follow-up study visits at one (1) and three (3) months after final treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces. | Device | CLEAR + BRILLIANT TOUCH(R) diode laser 1440-nm and 1927-nm Combination Wavelength Treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Improvement in Photoaging Damage Appearance at 3 Months Post Treatment | Improvement in the appearance of at least one measurement of photoaging damage (fine wrinkles, skin texture, dyschromia/pigment, skin radiance, pore size or overall appearance), each assessed by the investigator using the quartile improvement score comparing standard 2D baseline photograph captured via Canfield VISIA CA system. The Quartile Improvement Score ranges from 0 to 4, with 0 = 0%, 1 = 1% to 25%, 2 = 26% to 50%, 3 = 51% to 75%, and 4 = 76% to 100% improvement. Higher scores indicated greater improvement. | 3 months post treatment, up to 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Improvement in Photoaging Damage Appearance at 1 Month Post Treatment | Improvement in the appearance of at least one measurement of photoaging damage (fine wrinkles, skin texture, dyschromia/pigment, skin radiance, pore size or overall appearance), each assessed by the investigator using the quartile improvement score comparing standard 2D baseline photograph captured via Canfield VISIA CA system. The Quartile Improvement Score ranges from 0 to 4, with 0 = 0%, 1 = 1% to 25%, 2 = 26% to 50%, 3 = 51% to 75%, and 4 = 76% to 100% improvement. Higher scores indicated greater improvement. |
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Inclusion Criteria:
Exclusion Criteria:
1. Pregnant, breastfeeding, or planning to become pregnant during the study. 2 History of any type of allergic reaction to lidocaine. 3. Recent and/or active localized or systemic infections. 4. Diagnosis/possibility of actinic keratosis, melasma, rosacea, or other significant skin conditions (e.g. skin cancer, active infections, cold sores, open wounds, rashes, burns, inflammation eczema, psoriasis).
5. Predisposition to keloid formation or excessive scarring. 6. Diagnosis of a condition that may compromise the immune system, such as: HIV, lupus, scleroderma, and/or systemic infections.
7. Known sensitivity to light or photosensitizing agents/medications are being taken.
8. Systemic steroids (e.g. prednisone, dexamethasone), which should be rigorously avoided prior to and throughout course of the treatment.
9. Use of retinoids less than 2 weeks prior to or during the study to completion.
10. Individuals undergoing Accutane™ treatment or drugs in a similar class. 11. Having skin that is still recovering from a cosmetic procedure: such as a chemical peel, or mechanical peel, or laser resurfacing within the previous 6 months.
12. Having had Botox injections, neurotoxin injections, or dermal fillers (such as collagen) within the past four months.
13. Sunburn and/or recent sun exposure on the treatment area in the last 2 weeks.
14. Subjects must agree to seek the advice of their medical doctor regarding any known or suspicious skin condition before laser treatment.
15. Any condition or situation that would prevent the subject from safely completing all protocol requirements for participation.
16. Subjects who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
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| Name | Affiliation | Role |
|---|---|---|
| Varsha Bhatt | Bausch Health Americas, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch Site 001 | Dallas | Texas | 75225 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm Handpieces | CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces.: CLEAR + BRILLIANT TOUCH(R) diode laser 1440-nm and 1927-nm Combination Wavelength Treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm Handpieces | CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces.: CLEAR + BRILLIANT TOUCH(R) diode laser 1440-nm and 1927-nm Combination Wavelength Treatment. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Mean Improvement in Photoaging Damage Appearance at 3 Months Post Treatment | Improvement in the appearance of at least one measurement of photoaging damage (fine wrinkles, skin texture, dyschromia/pigment, skin radiance, pore size or overall appearance), each assessed by the investigator using the quartile improvement score comparing standard 2D baseline photograph captured via Canfield VISIA CA system. The Quartile Improvement Score ranges from 0 to 4, with 0 = 0%, 1 = 1% to 25%, 2 = 26% to 50%, 3 = 51% to 75%, and 4 = 76% to 100% improvement. Higher scores indicated greater improvement. | Participants with 3 months of follow up were included | Posted | Mean | Standard Deviation | units on a scale | 3 months post treatment, up to 7 months |
|
7 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 | CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm Handpieces | CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces.: CLEAR + BRILLIANT TOUCH(R) diode laser 1440-nm and 1927-nm Combination Wavelength Treatment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health Americas, Inc | 19083009920 | susan.harris@bauschhealth.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 | Sep 13, 2021 | Nov 1, 2023 | Prot_SAP_000.pdf |
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| 1 month post treatment, up to 5 months |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Secondary | Mean Improvement in Photoaging Damage Appearance at 1 Month Post Treatment | Improvement in the appearance of at least one measurement of photoaging damage (fine wrinkles, skin texture, dyschromia/pigment, skin radiance, pore size or overall appearance), each assessed by the investigator using the quartile improvement score comparing standard 2D baseline photograph captured via Canfield VISIA CA system. The Quartile Improvement Score ranges from 0 to 4, with 0 = 0%, 1 = 1% to 25%, 2 = 26% to 50%, 3 = 51% to 75%, and 4 = 76% to 100% improvement. Higher scores indicated greater improvement. | Participants with 1 month of follow up were included. | Posted | Mean | Standard Deviation | units on a scale | 1 month post treatment, up to 5 months |
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| 28 |
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| 28 |
Contact sponsor for details.