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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:

MedlinePlus related topics: Skin Aging
U.S. FDA Resources

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
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 June 17, 2013