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Comparison of Outcome Parameters in Laser Rhytide Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00994474
First Posted: October 14, 2009
Last Update Posted: October 14, 2009
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.
Information provided by:
Laserklinik Karlsruhe
  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
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

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) ]
  • Fitzpatrick wrinkle score [ Time Frame: Before and after treatment (3 months) ]

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

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

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Ages Eligible for Study:   40 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00994474


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

Responsible Party: Christian Raulin/Professor Dr., Laserklinik Karlsruhe
ClinicalTrials.gov Identifier: NCT00994474     History of Changes
Other Study ID Numbers: LK_06_2009
First Submitted: October 13, 2009
First Posted: October 14, 2009
Last Update Posted: October 14, 2009
Last Verified: October 2009

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