Safety and Effectiveness of the CLEAR + BRILLIANT TOUCH(R) Diode Laser 1440-nm and 1927-nm Combination Wavelength Treatment

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Study Evaluating the Safety and Effectiveness of the CLEAR + BRILLIANT TOUCH(R) Diode Laser 1440-nm and 1927-nm Combination Wavelength Treatment.

Conditions
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Photoaging

Intervention / Treatment
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* Device: CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female. 18 to 65 years of age. Written and oral informed consent must be obtained. No more than Mild (I) to Moderate (II) classification on Glogau Photodamage Scale. Fitzpatrick skin types I-VI. Fitzpatrick wrinkle & elastosis scale class I-II, score 1-6 (fine wrinkles and mild elastosis). Ability to read, understand and sign the informed consent form. Agree not to take any new medications (unless prescribed by the study investigator) or undergo any other procedures that may potentially treat photodamaged skin (any other aesthetic treatments) during the study. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces<br> | Device: CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces.<br>* CLEAR + BRILLIANT TOUCH(R) diode laser 1440-nm and 1927-nm Combination Wavelength Treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 1 month post treatment, up to 5 months |