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Ablative Fractional Lasers to Treat Peri-orbital Rhytides

L

Laserklinik Karlsruhe

Status and phase

Completed
Phase 4

Conditions

Peri-orbital Rhytides

Treatments

Procedure: Fractional carbon dioxide laser treatment
Procedure: Fractional erbium:YAG laser treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT00990431
LK_05_2009

Details and patient eligibility

About

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).

Enrollment

28 patients

Sex

All

Ages

40 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

28 participants in 2 patient groups

Carbon dioxide laser treatment
Active Comparator group
Treatment:
Procedure: Fractional carbon dioxide laser treatment
Erbium:YAG laser treatment
Active Comparator group
Treatment:
Procedure: Fractional erbium:YAG laser treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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