Skin Aging Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | March 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 40 Years to 55 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Germany | Laserklinik Karlsruhe | Karlsruhe |
Lead Sponsor | Collaborator |
---|---|
Laserklinik Karlsruhe |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quantitative measurement of wrinkle depth | Before and after treatment (3 months) | No | |
Primary | Fitzpatrick wrinkle score | Before and after treatment (3 months) | No | |
Secondary | Patient benefit index (PBI) | Before and after treatment (3 months) | No | |
Secondary | Patient satisfaction | 1, 3, 6 days and 3 months after treatment | No |
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