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Ablative Fractional Lasers to Treat Peri-orbital Rhytides

NCT00990431 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2009-10-14

No results posted yet for this study

Summary

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).

Conditions

  • Peri-orbital Rhytides

Interventions

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 %.

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.

Sponsors & Collaborators

  • Laserklinik Karlsruhe

    lead OTHER

Principal Investigators

  • Syrus Karsai, MD · Laserklinik Karlsruhe

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00990431 on ClinicalTrials.gov