Comparison of Outcome Parameters in Laser Rhytide Treatment

This study has been completed.
Sponsor:
Information provided by:
Laserklinik Karlsruhe
ClinicalTrials.gov Identifier:
NCT00994474
First received: October 13, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Skin Aging
Procedure: Fractional carbon dioxide laser treatment
Procedure: Fractional Er:YAG laser treatment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Comparison of Clinical Outcome Parameters, the Patient Benefit Index (PBI) and Patient Satisfaction After Ablative Fractional Laser Treatment of Peri-orbital Rhytides

Resource links provided by NLM:


Further study details as provided by Laserklinik Karlsruhe:

Primary Outcome Measures:
  • Quantitative measurement of wrinkle depth [ Time Frame: Before and after treatment (3 months) ] [ Designated as safety issue: No ]
  • Fitzpatrick wrinkle score [ Time Frame: Before and after treatment (3 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient benefit index (PBI) [ Time Frame: Before and after treatment (3 months) ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: 1, 3, 6 days and 3 months after treatment ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: August 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fractional carbon dioxide laser treatment 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.
Active Comparator: Fractional Er:YAG laser treatment 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.

  Eligibility

Ages Eligible for Study:   40 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00994474

Locations
Germany
Laserklinik Karlsruhe
Karlsruhe, Germany, D-76133
Sponsors and Collaborators
Laserklinik Karlsruhe
Investigators
Principal Investigator: Syrus Karsai, MD Laserklinik Karlsruhe
  More Information

No publications provided

Responsible Party: Christian Raulin/Professor Dr., Laserklinik Karlsruhe
ClinicalTrials.gov Identifier: NCT00994474     History of Changes
Other Study ID Numbers: LK_06_2009
Study First Received: October 13, 2009
Last Updated: October 13, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Laserklinik Karlsruhe:
Laser surgery
Profilometry
Fitzpatrick wrinkle score
Patient Benefit Index
Patient satisfaction

ClinicalTrials.gov processed this record on July 26, 2014