NCT00990431

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2009

Completed
Last Updated

October 14, 2009

Status Verified

October 1, 2009

Enrollment Period

6 months

First QC Date

October 5, 2009

Last Update Submit

October 13, 2009

Conditions

Peri-orbital Rhytides

Keywords

skin aginglaser surgeryfractional photothermolysiscomparative studyAblative fractional treatment of peri-orbital rhytides

Outcome Measures

Primary Outcomes (2)

  • Objective wrinkle depth

    3 months

  • Wrinkle severity (according to Fitzpatrick´s wrinkle score)

    3 months

Secondary Outcomes (1)

  • Patient satisfaction

    3 months

Study Arms (2)

Carbon dioxide laser treatment

ACTIVE COMPARATOR
Procedure: Fractional carbon dioxide laser treatment

Erbium:YAG laser treatment

ACTIVE COMPARATOR
Procedure: Fractional erbium:YAG laser treatment

Interventions

Fractional carbon dioxide laser treatmentPROCEDURE

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 %.

Carbon dioxide laser treatment
Fractional erbium:YAG laser treatmentPROCEDURE

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.

Erbium:YAG laser treatment

Eligibility Criteria

Age40 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 40-55
  • mild to moderate peri-orbital rhytides

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laserklinik Karlsruhe

Karlsruhe, D-76133, Germany

Location

Study Officials

  • Syrus Karsai, MD

    Laserklinik Karlsruhe

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 5, 2009

First Posted

October 6, 2009

Study Start

August 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

October 14, 2009

Record last verified: 2009-10

Locations

DE(1)