Comparison of Outcome Parameters in Laser Rhytide Treatment

Study Overview
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Brief Summary
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We previously published a comparative split-face study which has shown a significant, albeit moderate, effect of ablative fractional laser treatment. While indicating that a single session with fractional ablative lasers can be effective in the treatment of peri-orbital wrinkles, the trial also revealed substantial disagreement between the different end points (profilometry, Fitzpatrick wrinkle score, patient satisfaction). Since the PBI is a patient-related index it could not be included in the aforementioned split-face trial; the present study therefore attempts to further elucidate the patient-related benefit of a single fractional ablative laser treatment session as well as carefully analyse the respective correlations between the outcome parameters employed.

Official Title
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Comparison of Clinical Outcome Parameters, the Patient Benefit Index (PBI) and Patient Satisfaction After Ablative Fractional Laser Treatment of Peri-orbital Rhytides

Conditions
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Skin Aging

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: mild to moderate peri-orbital rhytides ('crow's feet') at rest (Class II according to Fitzpatrick) 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., psoriasis, cancer, or 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: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fractional carbon dioxide laser treatment<br> | Procedure: Fractional carbon dioxide laser treatment<br>* With the CO2 laser (Fraxel Re:pair, Solta Medical Inc., Hayward, CA), patients received two passes at 15 mJ (1st pass) and 20 mJ (2nd pass), respectively, with a total density of 20 %. We employed 'pin-point bleeding' and serosanguinous exudate as a clinical end point. The pulse duration was 10 msec.<br>|
| Active Comparator: Fractional Er:YAG laser treatment<br> | Procedure: Fractional Er:YAG laser treatment<br>* The Er:YAG laser (MCL 30 Dermablate, Asclepion Laser Technologies GmbH, Jena, Germany) was used in 4 passes with a total fluence of 60 J/cm² and pulse stacking (6 stacked pulses); the pulse duration was 400 μsec.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative measurement of wrinkle depth |  | Before and after treatment (3 months) | 
| Fitzpatrick wrinkle score |  | Before and after treatment (3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient benefit index (PBI) |  | Before and after treatment (3 months) | 
| Patient satisfaction |  | 1, 3, 6 days and 3 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laser surgery, Profilometry, Fitzpatrick wrinkle score, Patient Benefit Index, Patient satisfaction