NCT00994474

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2009

Completed
Last Updated

October 14, 2009

Status Verified

October 1, 2009

Enrollment Period

7 months

First QC Date

October 13, 2009

Last Update Submit

October 13, 2009

Conditions

Skin Aging

Keywords

Laser surgeryProfilometryFitzpatrick wrinkle scorePatient Benefit IndexPatient satisfaction

Outcome Measures

Primary Outcomes (2)

  • Quantitative measurement of wrinkle depth

    Before and after treatment (3 months)

  • Fitzpatrick wrinkle score

    Before and after treatment (3 months)

Secondary Outcomes (2)

  • Patient benefit index (PBI)

    Before and after treatment (3 months)

  • Patient satisfaction

    1, 3, 6 days and 3 months after treatment

Study Arms (2)

Fractional carbon dioxide laser treatment

ACTIVE COMPARATOR
Procedure: Fractional carbon dioxide laser treatment

Fractional Er:YAG laser treatment

ACTIVE COMPARATOR
Procedure: Fractional Er:YAG laser treatment

Interventions

Fractional carbon dioxide laser treatmentPROCEDURE

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 carbon dioxide laser treatment
Fractional Er:YAG laser treatmentPROCEDURE

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.

Fractional Er:YAG laser treatment

Eligibility Criteria

Age40 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • mild to moderate peri-orbital rhytides ('crow's feet') at rest (Class II according to Fitzpatrick)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laserklinik Karlsruhe

Karlsruhe, D-76133, Germany

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Syrus Karsai, MD

    Laserklinik Karlsruhe

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 13, 2009

First Posted

October 14, 2009

Study Start

August 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

October 14, 2009

Record last verified: 2009-10

Locations

DE(1)