Comparison of Outcome Parameters in Laser Rhytide Treatment

Skin Aging Clinical Trial

Official title:

Comparison of Clinical Outcome Parameters, the Patient Benefit Index (PBI) and Patient Satisfaction After Ablative Fractional Laser Treatment of Peri-orbital Rhytides

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00994474
• Other study ID #: LK_06_2009
• Status: Completed
• Phase: Phase 4
• First received: October 13, 2009
• Last updated: October 13, 2009
• Start date: August 2008
• Est. completion date: March 2009

Study information

• Verified date: October 2009
• Source: Laserklinik Karlsruhe
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Skin Aging

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Germany	Laserklinik Karlsruhe	Karlsruhe

Sponsors (1)

Lead Sponsor	Collaborator
Laserklinik Karlsruhe

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative measurement of wrinkle depth		Before and after treatment (3 months)	No
Primary	Fitzpatrick wrinkle score		Before and after treatment (3 months)	No
Secondary	Patient benefit index (PBI)		Before and after treatment (3 months)	No
Secondary	Patient satisfaction		1, 3, 6 days and 3 months after treatment	No