Comparison of Outcome Parameters in Laser Rhytide Treatment

NCT ID: NCT00994474

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: 2009-03-31

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.

Conditions

Skin Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

Fractional carbon dioxide laser treatment

Group Type: ACTIVE_COMPARATOR

Fractional carbon dioxide laser treatment

Intervention Type: PROCEDURE

With the CO2 laser (Fraxel Re:pair, Solta Medical Inc., Hayward, CA), patients received two passes at 15 mJ (1st pass) and 20 mJ (2nd pass), respectively, with a total density of 20 %. We employed 'pin-point bleeding' and serosanguinous exudate as a clinical end point. The pulse duration was 10 msec.

Fractional Er:YAG laser treatment

Group Type: ACTIVE_COMPARATOR

Fractional Er:YAG laser treatment

Intervention Type: PROCEDURE

The Er:YAG laser (MCL 30 Dermablate, Asclepion Laser Technologies GmbH, Jena, Germany) was used in 4 passes with a total fluence of 60 J/cm² and pulse stacking (6 stacked pulses); the pulse duration was 400 μsec.

Interventions

Fractional carbon dioxide laser treatment

With the CO2 laser (Fraxel Re:pair, Solta Medical Inc., Hayward, CA), patients received two passes at 15 mJ (1st pass) and 20 mJ (2nd pass), respectively, with a total density of 20 %. We employed 'pin-point bleeding' and serosanguinous exudate as a clinical end point. The pulse duration was 10 msec.

Intervention Type: PROCEDURE

Fractional Er:YAG laser treatment

The Er:YAG laser (MCL 30 Dermablate, Asclepion Laser Technologies GmbH, Jena, Germany) was used in 4 passes with a total fluence of 60 J/cm² and pulse stacking (6 stacked pulses); the pulse duration was 400 μsec.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• 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_06_2009

Identifier Type: -

Identifier Source: org_study_id