Hybrid Fractional Laser for Treatment of Off Face Body Skin Quality

Study Overview
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Brief Summary
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To demonstrate effectiveness of hybrid fractional laser for the treatment of poor skin quality on the decolletage, back of the hands and lower legs

Official Title
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Non-Randomized, Open-label, Blinded Evaluator Study Characterizing Effectiveness of Hybrid Fractional Laser for the Treatment of Off Face Body Skin Quality

Conditions
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Skin Laxity

Intervention / Treatment
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* Device: Hybrid Fractional Laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male/female subjects between 40 to 65 years of age inclusive Fitzpatrick skin type I-III Non-smokers or have not smoked (including vaping) within the past 14 days from the screening visit Has poor skin texture Has mild thin skin Has some level of dyschromia on the treatment area as assessed by the Investigator Can read, understand and sign informed consent form (English only) Has indicated willingness to participate in the study by signing an informed consent form Agrees to adhere to the treatment and follow-up schedule and post treatment care instructions Exclusion Criteria: Fitzpatrick skin type IV-VI Has tanned within the past 30 days or is unable or unlikely to refrain from tanning, including the use of tanning booths, tanning spray or cream Has tattoos, dysplastic nevi on the treatment area Is pregnant and/or lactating History or current photosensitivity History or current use of medication with photosensitizing properties within past 6 months History or current of chronic reoccurring skin disease or disorder affecting treatment area History or current cancer of any type Has signs of actinic bronzing Has open lacerations, and abrasions on the treatment area History of keloid formation, or hypertrophic scar formation, or poor wound healing History of bleeding disorder, or is currently taking anticoagulation medications Has significant concurrent illnesses (controlled or uncontrolled), such as diabetes, lupus, epilepsy, or cardiac disorders, which might be aggravated as a result of treatment Has participated in any clinical trial involving an investigational drug, device or cosmetic product or procedure within the past 30 days The investigator feels that for any reason the subject is not eligible to participate in the study

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Hybrid Fractional Laser<br>Hybrid Fractional Laser Treatment | Device: Hybrid Fractional Laser<br>* Hybrid Fractional Laser Device<br>* Other names: HALO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photography | Evaluate improvement in photography using Physicians Global Assessment Scale (0-4) where 0 is no change and 4 is very significant improvement. | 3 months |