The Efficacy of the Alma Hybrid System for a New Approach of Facial Skin Treatment

Study Overview
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Brief Summary
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The study is aimed to evaluate the efficacy of the Alma Hybrid system for a new approach of facial skin treatment, using both ablative and non-ablative wavelengths. The study will include 20 subjects with mild-moderate photodamaged skin, that will undergo 2 facial skin treatments. Follow up visit to evaluate the efficacy of the treatments will take place 1 and 3 months after the last treatment.

Official Title
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Prospective, Single-Center, Open-Label Study to Evaluate the Efficacy of the Alma Hybrid System for New Approach of Facial Skin Treatment With Minimal Downtime

Conditions
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Rejuvenation

Intervention / Treatment
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* Device: Facial skin treatment


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Male or Female, 35 to 60 years of age, at the time of enrollment Fitzpatrick skin type I-IV Mild-moderate photo damages and wrinkles, with Fitzpatrick-Goldman Wrinkle and Elastosis Score of 3-6 Main Exclusion Criteria: Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding Heavy smoker (>1 pack of cigarettes a day) Unable or unlikely to refrain from tanning, including the use of tanning booths, during the course of the study Previous rejuvenation treatments on the same area, such as chemical peel, dermabrasion, non-ablative or ablative resurfacing procedure, or face-lift with laser or other devices, up to 3 months prior to the enrollment Prior use of collagen, fat injections, or other methods of skin augmentation within the past 12 months. Prior use of Botox in the treatment area within 5 months Infection, dermatitis, rash, or other skin abnormality in the target area History of any disease or condition that could impair wound healing History of keloid formation, hypertrophic scarring, or abnormal/delayed wound healing

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 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: Facial skin treatment<br>Facial skin treatment using the Alma Hybrid system. | Device: Facial skin treatment<br>* Facial skin treatment using the Alma Hybrid system with a unique pattern that includes both ablative and non-ablative wavelengths<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator assessment | Investigator assessment of the overall facial skin aesthetic appearance using a 5 point Likert scale (when 1 indicate not at all improved and 5 indicates  very much improved | 3 month after last treatment |