Ablative Fractional Lasers to Treat Peri-orbital Rhytides

Study Overview
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Brief Summary
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Ablative fractional lasers were introduced for treating facial rhytides in an attempt to achieve results comparable to traditional ablative resurfacing but with fewer side effects. However, there is conflicting evidence on how well this goal has generally been achieved as well as on the comparative value of fractional CO2 and Er:YAG lasers. The present study compares these modalities in a randomized controlled blinded split-face study design: 28 patients were enrolled and completed the entire study. Patients were randomly assigned to receive a single treatment on each side of the peri-orbital region, one with a fractional CO2 and one with a fractional Er:YAG laser. The evaluation included Fitzpatrick wrinkle score, profilometric measurement of wrinkle depth (both before and 3 months after treatment) as well as assessment of side effects and patient satisfaction (1, 3, 6 days and 3 months after treatment).

Official Title
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Ablative Fractional Lasers (CO2 and Er:YAG): A Randomized Controlled Blinded Split-face Trial of the Treatment of Peri-orbital Rhytides

Conditions
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Peri-orbital Rhytides

Intervention / Treatment
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* Procedure: Fractional carbon dioxide laser treatment
* Procedure: Fractional erbium:YAG laser treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 40-55 mild to moderate peri-orbital rhytides Exclusion Criteria: unrealistic expectations inability to meet follow-up criteria Fitzpatrick skin phototype >III coagulation disorders or anti-coagulant treatment allergy to lidocaine or tetracaine oral isotretinoin within the last 6 months any active skin disease within the treatment areas (e. g., cancer, autoimmune disease) synthetic implants in the treatment area facial cosmetic procedures affecting the treatment area within the last 6 months photosensitizing medications (e. g., tetracycline, gold) history of keloid formation pregnancy

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 55 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Carbon dioxide laser treatment<br> | Procedure: Fractional carbon dioxide laser treatment<br>* The CO2 laser (Fraxel Re:pair, Solta Medical Inc., Hayward, CA) employs disposable tips with a diameter of 7 mm and 15 mm, the smaller being used for the peri-orbital region. The laser beam is delivered through multiple deflective and refractive elements and focused to a spot size of approximately 120 µm in diameter at incidence to the skin to deposit an array of laser beams across the surface. Pulse energy varies from 5 to 70 mJ and density from 5 to 70 %. The pulse duration is 10 msec. In the present study, patients received two passes at 15 mJ (1st pass) and 20 mJ (2nd pass), respectively, with a total density of 20 %.<br>|
| Active Comparator: Erbium:YAG laser treatment<br> | Procedure: Fractional erbium:YAG laser treatment<br>* The Er:YAG laser used in this study has a fractional handpiece (MCL 30 Dermablate, Asclepion Laser Technologies GmbH, Jena, Germany). By means of a microlens array the laser beam is divided into 13 x 13 small spots with 250 µm diameter each, spread over an area of 13 x 13 mm. A coverage of 5 % of the skin is achieved with a single pass. The pulse duration is 400 μsec. In this trial, we performed 4 passes (resulting in coverage of 20 % of the treated skin) with a total fluence of 60 J/cm² and pulse stacking (6 stacked pulses) to optimize thermal exposure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective wrinkle depth |  | 3 months | 
| Wrinkle severity (according to Fitzpatrick´s wrinkle score) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skin aging, laser surgery, fractional photothermolysis, comparative study, Ablative fractional treatment of peri-orbital rhytides