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NCT02195427

A Controlled, Randomized, Double-Blinded, Within-Subject, Multicenter, Prospective Clinical Study of TEOSYAL® RHA Global Action and TEOSYAL® RHA Deep Lines Versus Juvéderm® Ultra XC in the Treatment of Moderate to Severe Nasolabial Folds

Completed NA Results posted Last updated 26 March 2018
What this trial tests

NA trial testing TEOSYAL® RHA Global Action in Nasolabial Folds, Wrinkles in 148 participants. Completed in 1 March 2016.

Timeline
1 June 2014
Primary endpoint
1 March 2015
1 March 2016

Quick facts

Lead sponsorTeoxane SA
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment148
Start date1 June 2014
Primary completion1 March 2015
Estimated completion1 March 2016
Sites5 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Teoxane SA

Who can join

22 and older, any sex, with Nasolabial Folds, Wrinkles. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

The purpose of this study is 1) to compare the effectiveness and safety of TEOSYAL® RHA Global Action versus Juvéderm® Ultra XC, and 2) to compare the effectiveness and safety of TEOSYAL® RHA Deep Lines versus Juvéderm® Ultra XC, in the treatment of moderate to severe nasolabial folds.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Effectiveness and Safety of Resilient Hyaluronic Acid (RHA) Dermal Fillers for the Correction of Moderate-to-Severe Nasolabial Folds in People of Color: Post Hoc Subgroup Analyses of US Pivotal Clinical Data.
    Taylor S, Weinkle S, Kaufman-Janette J, Gallagher CJ, et al · · 2024 · cited 1× · PMID 37556827 · DOI 10.1093/asj/sjad251

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Other recruiting trials for Nasolabial Folds, Wrinkles

Currently open trials in the same condition.

Other Teoxane SA trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02195427.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing