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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

October 13, 2009
October 13, 2009
August 2008
March 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Comparison of Outcome Parameters in Laser Rhytide Treatment
Comparison of Clinical Outcome Parameters, the Patient Benefit Index (PBI) and Patient Satisfaction After Ablative Fractional Laser Treatment of Peri-orbital Rhytides

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Skin Aging
  • 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.
  • 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.
  • Active Comparator: Fractional carbon dioxide laser treatment
    Intervention: Procedure: Fractional carbon dioxide laser treatment
  • Active Comparator: Fractional Er:YAG laser treatment
    Intervention: Procedure: Fractional Er:YAG laser treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
40 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00994474
LK_06_2009
No
Christian Raulin/Professor Dr., Laserklinik Karlsruhe
Laserklinik Karlsruhe
Not Provided
Principal Investigator: Syrus Karsai, MD Laserklinik Karlsruhe
Laserklinik Karlsruhe
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP