Treatment of Periorbital and Perioral Wrinkles With the Applications of the Iluminage Diode Laser

Study Overview
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Brief Summary
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The Diode laser system is being used in this marketing study for the treatment of wrinkles around the eyes and mouth.

Conditions
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Peri-orbital Wrinkles, Peri-oral Wrinkles

Intervention / Treatment
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* Device: Illuiminage ® Diode Laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who are healthy females between 35 and 60 years of age. Subjects who have Fitzpatrick skin type I-VI Subjects who have provided written and verbal informed consent Subjects who are willing and able to comply with study instructions and to return to the clinic for required visits and have photographs of their face taken Subjects who have perioral and periorbital wrinkles, as deemed appropriate by the Investigator or his designees Exclusion Criteria: Subjects who currently use or have used in the prior 30 days any skin products that contain alpha hydroxy acids (AHA) e.g. glycolic, lactic, citric, or mendelic acid containing products or retinol/tretinoin containing products or exfoliating washes, masks or scrubs or other micro-dermabrasion skin care products. on the laser application areas Subjects who are unwilling to maintain their daily skin care regimen for the duration of the study, Subjects who have any skin pathology or condition that could interfere with the evaluation i.e. personal or family history of skin cancer, rosacea and/or requires the use of interfering topical or systemic therapies. Subjects with synthetic or metal implants or permanent cosmetic tattoos in the test areas Subjects who have a history of abnormal scarring, e.g. keloids or have significant scarring in the areas to be treated Subjects with bleeding disorders or taking anticoagulation medications, including heavy use of aspirin Subjects who have participated in any clinical investigation involving the face within the 30 days prior to the first planned laser application or subjects who plan to participate in concomitant facial studies during this trial Subjects, who are pregnant, were pregnant or gave birth in the last 3 months, are currently breast feeding, or might become pregnant during the course of the study Subjects who have a history of light triggered seizures Subjects with prior use of neurotoxins e.g. Botox®, collagen, fat injections and/or other methods of skin augmentation (enhancement with injected or implanted material) of the face or having had chemical peels within 6 months of initial laser application or planning to so during the course of the study Subject's use of oral isotretinoin (Accutane®) within 12 months of initial laser application or during the course of the study Subjects having had facial skin treatments with any professional laser, light based, radiofrequency or other devices within the last year Subjects ever having facial skin treatments with home use laser, light based or radiofrequency or other devices, i.e. PaloVia® or Tria®

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

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: Diode laser<br>Diode laser to treat peri-orbital and peri-oral wrinkles | Device: Illuiminage ® Diode Laser<br>* Diode laser for treatment of peri-orbital and peri-oral wrinkles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photographic Evaluation | Compare severity of wrinkles from baseline to 60 days post treatment based on Fitpatrick Scale. | 60 days post first treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events | Adverse events and side effects will be recorded | up to 4 months post 1st treatment | 
| Photographic Evaluation | Compare severity of wrinkles from baseline to 1,10, 20 and 40 days post treatment based on Fitzpatrick Scale. | Up to 40 days |