Ablative Fractional Lasers to Treat Peri-orbital Rhytides

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

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).

Study Overview

• Status: Completed
• Conditions: Peri-orbital Rhytides
• Intervention / Treatment: Procedure: Fractional carbon dioxide laser treatment; Procedure: Fractional erbium:YAG laser treatment

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Karlsruhe, Germany, D-76133
    • Laserklinik Karlsruhe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Carbon dioxide laser treatment	Procedure: Fractional carbon dioxide laser treatment; 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 %.
Active Comparator: Erbium:YAG laser treatment	Procedure: Fractional erbium:YAG laser treatment; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient satisfaction	3 months

Collaborators and Investigators

• Sponsor: Laserklinik Karlsruhe

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: October 5, 2009
• First Submitted That Met QC Criteria: October 5, 2009
• First Posted (Estimate): October 6, 2009

Study Record Updates

• Last Update Posted (Estimate): October 14, 2009
• Last Update Submitted That Met QC Criteria: October 13, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: comparative study; skin aging; laser surgery; fractional photothermolysis; Ablative fractional treatment of peri-orbital rhytides
• Other Study ID Numbers: LK_05_2009