Ablative Fractional Lasers to Treat Peri-orbital Rhytides

This study has been completed.
Sponsor:
Information provided by:
Laserklinik Karlsruhe
ClinicalTrials.gov Identifier:
NCT00990431
First received: October 5, 2009
Last updated: October 13, 2009
Last verified: October 2009
  Purpose

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).


Condition Intervention Phase
Peri-orbital Rhytides
Procedure: Fractional carbon dioxide laser treatment
Procedure: Fractional erbium:YAG laser treatment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ablative Fractional Lasers (CO2 and Er:YAG): A Randomized Controlled Blinded Split-face Trial of the Treatment of Peri-orbital Rhytides

Resource links provided by NLM:


Further study details as provided by Laserklinik Karlsruhe:

Primary Outcome Measures:
  • Objective wrinkle depth [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Wrinkle severity (according to Fitzpatrick´s wrinkle score) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient satisfaction [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: August 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00990431

Locations
Germany
Laserklinik Karlsruhe
Karlsruhe, Germany, D-76133
Sponsors and Collaborators
Laserklinik Karlsruhe
Investigators
Principal Investigator: Syrus Karsai, MD Laserklinik Karlsruhe
  More Information

No publications provided

Responsible Party: Christian Raulin/Professor Dr., Laserklinik Karlsruhe
ClinicalTrials.gov Identifier: NCT00990431     History of Changes
Other Study ID Numbers: LK_05_2009
Study First Received: October 5, 2009
Last Updated: October 13, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Laserklinik Karlsruhe:
skin aging
laser surgery
fractional photothermolysis
comparative study
Ablative fractional treatment of peri-orbital rhytides

ClinicalTrials.gov processed this record on October 20, 2014