Safety and Efficacy Study for Various Skin Conditions

Study Overview
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Brief Summary
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Characterizing safety and efficacy of Halo Laser Treatment for Various Skin Conditions.

Detailed Description
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The purpose of this study is to demonstrate safety and efficacy of Halo treatment as measured by changes in skin tone, texture and pigment.

Official Title
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Characterizing Safety and Efficacy of Halo Hybrid Fractional Laser Treatments for Various Skin Conditions

Conditions
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Dyschromia, Photodamaged Skin

Intervention / Treatment
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* Device: HALO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fitzpatrick Skin types I to IV Desires improvement of significant skin conditions on the face and/or neck Willingness to participate in the study by signing an informed consent form Will have limited sun exposure for at least two weeks prior to study screening and during the study, including the follow-up period Able to adhere to the treatment and follow-up schedule and post-treatment care instructions Post-menopausal or surgically sterilized female subjects. Exclusion Criteria: History of Halo or resurfacing procedures in the treatment area within past six months Has tanned within the past thirty days or unable or unlikely to refrain from tanning, including the use of tanning booths, tanning spray, or cream Has tattoos, dysplastic nevi in the treatment area Pregnant and/or lactating Is planning to get pregnant within the study period Has a known history of photosensitivity Has used medication with photosensitizing properties within the past six months, e.g. isotretinoin History or evidence of chronic or recurring skin disease or disorder (e.g. psoriasis, --Netherton syndrome, etc.) affecting the treatment area Has open lacerations, abrasions, active cold sores, or herpes sores Has hormonal disorders History of keloid or hypertrophic scar formation or poor wound healing History of immunosuppression or immune deficiency disorder (including HIV infection or AIDS) or use of immunosuppressive medications History of bleeding disorder or taking anticoagulation medications History of skin cancer or any other cancer in the treatment area Has significant concurrent illnesses, 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 or cosmetic product or procedure within the past thirty 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: 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hybrid Fractional Laser Treatment<br>Halo (1470nm and 2940 nm) laser | Device: HALO<br>* Laser Treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in skin conditions assessed by photographs | Assessment of photographs by blinded evaluators | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject satisfaction post final treatment | Assessment of subject satisfaction with treatment result using survey/questionnaire | 3 months |