Comparison of Outcome Parameters in Laser Rhytide Treatment

Phase 4

Completed

• Conditions: Skin Aging
• Interventions: Procedure: Fractional carbon dioxide laser treatment

• Registration Number: NCT00994474
• Lead Sponsor: Laserklinik Karlsruhe

Brief Summary

We previously published a comparative split-face study which has shown a significant, albeit moderate, effect of ablative fractional laser treatment. While indicating that a single session with fractional ablative lasers can be effective in the treatment of peri-orbital wrinkles, the trial also revealed substantial disagreement between the different end points (profilometry, Fitzpatrick wrinkle score, patient satisfaction). Since the PBI is a patient-related index it could not be included in the aforementioned split-face trial; the present study therefore attempts to further elucidate the patient-related benefit of a single fractional ablative laser treatment session as well as carefully analyse the respective correlations between the outcome parameters employed.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2009-10
• Study First Submitted: 2009-10-13
• Study First Submitted QC: 2009-10-13
• Last Update Submitted: 2009-10-13
• Study First Posted: 2009-10-14
• Last Update Posted: 2009-10-14

Recruitment & Eligibility

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

Inclusion Criteria

• mild to moderate peri-orbital rhytides ('crow's feet') at rest (Class II according to Fitzpatrick)

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., psoriasis, cancer, or 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: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Quantitative measurement of wrinkle depth	Before and after treatment (3 months)
Fitzpatrick wrinkle score	Before and after treatment (3 months)

Secondary Outcome Measures

Name	Time	Method
Patient benefit index (PBI)	Before and after treatment (3 months)
Patient satisfaction	1, 3, 6 days and 3 months after treatment

Trial Locations

Locations (1)

Laserklinik Karlsruhe; 🇩🇪 Karlsruhe, Germany