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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00994474 |
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Date of registration:
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13/10/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparison of Outcome Parameters in Laser Rhytide Treatment
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Scientific title:
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Comparison of Clinical Outcome Parameters, the Patient Benefit Index (PBI) and Patient Satisfaction After Ablative Fractional Laser Treatment of Peri-orbital Rhytides |
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Date of first enrolment:
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August 2008 |
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Target sample size:
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28 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00994474 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
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Phase:
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Phase 4
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Countries of recruitment
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Germany
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Contacts
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Name:
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Syrus Karsai, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Laserklinik Karlsruhe |
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Key inclusion & exclusion criteria
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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
Age minimum:
40 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Skin Aging
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Intervention(s)
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Procedure: Fractional carbon dioxide laser treatment
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Procedure: Fractional Er:YAG laser treatment
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Primary Outcome(s)
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Fitzpatrick wrinkle score
[Time Frame: Before and after treatment (3 months)]
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Quantitative measurement of wrinkle depth
[Time Frame: Before and after treatment (3 months)]
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Secondary Outcome(s)
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Patient benefit index (PBI)
[Time Frame: Before and after treatment (3 months)]
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Patient satisfaction
[Time Frame: 1, 3, 6 days and 3 months after treatment]
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Secondary ID(s)
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LK_06_2009
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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