Safety and Efficacy Evaluation of Erbium Treatment

Study Overview
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Brief Summary
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The purpose of this research study is to evaluate the safety and effectiveness of erbium lasers for dermatological cosmetic procedures.

Detailed Description
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The purpose of this investigation is to evaluate erbium laser devices for dermatological cosmetic procedures. Each subject will undergo up to 6 treatment sessions, with scheduled time-points for follow-up visits. The Investigator determines the number of treatments. Subjects may be treated on there face, neck, chest or other body areas as deemed appropriate by the Investigator. At each visit, the treated areas will be clinically evaluated for side effects and will also have photographs taken of their treated areas. Subjects will be asked to complete a self-assessment questionnaire at different time points throughout their study participation.

Official Title
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Safety and Efficacy Evaluation of Fractional Erbium Treatment

Conditions
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Skin Aging

Intervention / Treatment
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* Device: Erbium laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female Adults (18 years or older). Subjects who can read, understand, and sign the Informed Consent Form. Subjects willing and able to comply with all study requirements. Exclusion Criteria: Subjects with active localized or systemic infections. Immunocompromised subjects. Subjects with coagulation disorder. History of skin photo sensitivity disorders, or use of photosensitizing drugs (e.g., tetracycline or sulfa drugs). Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of study). In the opinion of the trained clinician, subject is unwilling or unable to adhere to all study requirements, including application and follow-up visits. Use of Accutane® within the past 6 months. Subjects with a history of radiation therapy to the treatment area. Subjects with any skin pathology or condition that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during or after treatments. Subjects have undergone dermatological procedures (e.g., laser or light treatments) for the treatment of wrinkles, skin resurfacing, or skin rejuvenation in the treatment area within 1 year of study participation.

Ages Eligible for Study
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Minimum Age: 18 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

| Intervention/Treatment |
| --- |
|Device: Erbium laser|Erbium laser treatment. Each subject will undergo up to 6 treatment sessions|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants That Scored Above a One Category (Mild) Improvement Using the Fitzpatrick Wrinkle Scale. | To assess wrinkle improvement, 3 blinded evaluators use the validated Fitzpatrick Wrinkle Scale (FWS), a 0 to 9 (0=no wrinkles, 9=severe wrinkles) point scale to score the degree of wrinkles, fine lines, and the severity of skin elastosis. Evaluators assign a FWS score to pre-treatment and post-treatment photographs. The difference between the two scores is the amount (i.e., category) of wrinkle improvement. An improvement of one category means a mild improvement in wrinkle reduction. | participants at three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants That Have Reduction in Pigmented Lesions and Dyschromia. | To assess reductions in pigmented lesions and dyschromia, blinded evaluators were asked to assess pre-treatment and post-treatment photographs. The blinded evaluators were asked to grade percent improvement for pigmentation using a 0 to 10 scale (0=none and 10=severe) and the following quartile improvement scale: 1=1-24%, 2=25-49%, 3=50-74% and 4=75-100%. The blinded-evaluator scores were tabulated and analyzed in order to assess the effects. | participants at three months |