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Completed

NCT Number: NCT00990431

Ablative Fractional Lasers to Treat 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).

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Key information

Conditions

Peri-orbital Rhytides

Age range

40 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Laserklinik Karlsruhe

Karlsruhe, D-76133, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fractional carbon dioxide laser treatment

Procedure

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 %.

Fractional erbium:YAG laser treatment

Procedure

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.

Primary outcomes

  1. Objective wrinkle depth

    Time frame: 3 months

  2. Wrinkle severity (according to Fitzpatrick´s wrinkle score)

    Time frame: 3 months

Secondary outcomes

  1. Patient satisfaction

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Laserklinik Karlsruhe

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 6, 2009
Registry last updated
Oct 14, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.