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NCT Number: NCT00994474

Comparison of Outcome Parameters in Laser Rhytide Treatment

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.

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Key information

Conditions

Skin Aging Behavior Health Behavior Patient Satisfaction Treatment Adherence and Compliance

Age range

40 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Laserklinik Karlsruhe

Karlsruhe, D-76133, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fractional carbon dioxide laser treatment

Procedure

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.

Fractional Er:YAG laser treatment

Procedure

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Laserklinik Karlsruhe

Other

Registry information

Official study title

Comparison of Clinical Outcome Parameters, the Patient Benefit Index (PBI) and Patient Satisfaction After Ablative Fractional Laser Treatment of Peri-orbital Rhytides

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 14, 2009
Registry last updated
Oct 14, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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