CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 172 enrolled
Drug / intervention
EVOLENCE®device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00891774
NCT00891774N/ACompleted
CompareCT.gov

An Open-label, Multi-Center, Prospective, Post Market Study to Assess the Safety and Effectiveness of EVOLENCE® in Facial Augmentation of Subjects With Fitzpatrick Skin Color Types IV, V, and VI

Johnson & Johnson Consumer and Personal Products Worldwide·interventional·Posted May 1, 2009·Updated Feb 6, 2019

In Brief

A clinical study evaluating EVOLENCE® for Non Therapeutic Body Modification. Completed, enrolled 172 participants across 11 sites.

Detailed Summary

Approximately 165 subjects with Fitzpatrick Skin Color Types IV, V, and VI and a moderate to deep wrinkle between the corner of the nose and the corner of the mouth, will be treated with EVOLENCE® (an approved collagen filler) to smooth and flatten that wrinkle. They will be observed for 6 months to establish safety of the product as it relates to scarring and changes in skin pigment, and long term effectiveness.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon Therapeutic Body Modification
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 1, 2009
Enrollment StartDec 31, 2008
Primary CompletionNov 30, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 17.2 years ago

Interventions

EVOLENCE®device

Single injection of material into the mid-dermis of the wrinkle - Second 'touch-up' injection is permitted approximately 14-Days later if needed to achieve satisfactory results