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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00994474
Other study ID # LK_06_2009
Secondary ID
Status Completed
Phase Phase 4
First received October 13, 2009
Last updated October 13, 2009
Start date August 2008
Est. completion date March 2009

Study information

Verified date October 2009
Source Laserklinik Karlsruhe
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Germany Laserklinik Karlsruhe Karlsruhe

Sponsors (1)

Lead Sponsor Collaborator
Laserklinik Karlsruhe

Country where clinical trial is conducted

Germany, 

Outcome

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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