Comparison of Outcome Parameters in Laser Rhytide Treatment

L

Laserklinik Karlsruhe

Status and phase

Completed
Phase 4

Conditions

Skin Aging

Treatments

Procedure: Fractional Er:YAG laser treatment
Procedure: Fractional carbon dioxide laser treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT00994474
LK_06_2009

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

All

Ages

40 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Triple Blind

28 participants in 2 patient groups

Fractional carbon dioxide laser treatment
Active Comparator group
Treatment:
Procedure: Fractional carbon dioxide laser treatment
Fractional Er:YAG laser treatment
Active Comparator group
Treatment:
Procedure: Fractional Er:YAG laser treatment

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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