Ablative Fractional Lasers to Treat Peri-orbital Rhytides

Phase 4

Completed

• Conditions: Peri-orbital Rhytides
• Interventions: Procedure: Fractional carbon dioxide laser treatment

• Registration Number: NCT00990431
• Lead Sponsor: Laserklinik Karlsruhe

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2009-10
• Study First Submitted: 2009-10-05
• Study First Submitted QC: 2009-10-05
• Study First Posted: 2009-10-06
• Last Update Submitted: 2009-10-13
• Last Update Posted: 2009-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Carbon dioxide laser treatment	Fractional carbon dioxide laser treatment	-

Primary Outcome Measures

Name	Time	Method
Objective wrinkle depth	3 months
Wrinkle severity (according to Fitzpatrick´s wrinkle score)	3 months

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	3 months

Trial Locations

Locations (1)

Laserklinik Karlsruhe; 🇩🇪 Karlsruhe, Germany