Reducing Wrinkles Around the Eyes Using the Ulthera® System
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|ClinicalTrials.gov Identifier: NCT01368900|
Recruitment Status : Completed
First Posted : June 8, 2011
Results First Posted : July 31, 2013
Last Update Posted : December 13, 2017
|Study Design||Intervention Model: Single Group Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment|
Device: Ulthera® System treatment
|Recruitment Details||Sixty-eight subjects were enrolled at two aesthetic medical facilities. Study recruitment was initiated on March 3, 2011, and concluded on July 13, 2011. Forty-five subjects were enrolled at one study site; 23 subjects were enrolled at the second study site.|
|Pre-assignment Details||Subjects presenting with rhytids and skin laxity in the periorbital region, Fitzpatrick Wrinkle Classification Scale (FWCS)of 3 to 7, qualified for study participation. Note: A protocol amendment restricting enrollment to FWCS scores of 3-7 occurred after 19 subjects with FWCS = 2 had been enrolled.|
FWCS scores assessed globally, not per eye, leading to limited data for analysis.
FWCS protocol amended to 3+ after enrollment of 19 subjects with FWCS of 2.
Unacceptable lighting, focus, exposure making some photos impossible to evaluate.