Ablative Fractional Lasers to Treat Peri-orbital Rhytides

NCT ID: NCT00990431

Last Updated: 2009-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-02-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Carbon dioxide laser treatment

Group Type: ACTIVE_COMPARATOR

Fractional carbon dioxide laser treatment

Intervention Type: 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 %.

Erbium:YAG laser treatment

Group Type: ACTIVE_COMPARATOR

Fractional erbium:YAG laser treatment

Intervention Type: 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.

Interventions

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 %.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Laserklinik Karlsruhe

OTHER

Sponsor Role: lead

Responsible Party

Laserklinik Karlsruhe

Principal Investigators

Syrus Karsai, MD

Role: PRINCIPAL_INVESTIGATOR

Laserklinik Karlsruhe

Locations

Laserklinik Karlsruhe

Karlsruhe, , Germany

Countries

Germany

Other Identifiers

LK_05_2009

Identifier Type: -

Identifier Source: org_study_id