COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Comparison of Outcome Parameters in Laser Rhytide Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00994474
Recruitment Status : Completed
First Posted : October 14, 2009
Last Update Posted : October 14, 2009
Information provided by:
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.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, 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
Study Start Date : August 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Quantitative measurement of wrinkle depth [ Time Frame: Before and after treatment (3 months) ]
  2. Fitzpatrick wrinkle score [ Time Frame: Before and after treatment (3 months) ]

Secondary Outcome Measures :
  1. Patient benefit index (PBI) [ Time Frame: Before and after treatment (3 months) ]
  2. Patient satisfaction [ Time Frame: 1, 3, 6 days and 3 months after treatment ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   40 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00994474

Layout table for location information
Laserklinik Karlsruhe
Karlsruhe, Germany, D-76133
Sponsors and Collaborators
Laserklinik Karlsruhe
Layout table for investigator information
Principal Investigator: Syrus Karsai, MD Laserklinik Karlsruhe
Layout table for additonal information
Responsible Party: Christian Raulin/Professor Dr., Laserklinik Karlsruhe Identifier: NCT00994474    
Other Study ID Numbers: LK_06_2009
First Posted: October 14, 2009    Key Record Dates
Last Update Posted: October 14, 2009
Last Verified: October 2009
Keywords provided by Laserklinik Karlsruhe:
Laser surgery
Fitzpatrick wrinkle score
Patient Benefit Index
Patient satisfaction