Skin Aging
Conditions
Keywords
Laser surgery, Profilometry, Fitzpatrick wrinkle score, Patient Benefit Index, Patient satisfaction
Brief summary
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.
Interventions
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.
PROCEDUREFractional 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.
Sponsors
Laserklinik Karlsruhe
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantitative measurement of wrinkle depth | Before and after treatment (3 months) |
| Fitzpatrick wrinkle score | Before and after treatment (3 months) |
Secondary
| Measure | Time frame |
|---|---|
| Patient benefit index (PBI) | Before and after treatment (3 months) |
| Patient satisfaction | 1, 3, 6 days and 3 months after treatment |
Countries
Germany
Outcome results
None listed