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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
NA trial testing TEOSYAL® RHA Global Action in Nasolabial Folds, Wrinkles in 148 participants. Completed in 1 March 2016.
1 March 2015
Quick facts
| Lead sponsor | Teoxane SA |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 148 |
| Start date | 1 June 2014 |
| Primary completion | 1 March 2015 |
| Estimated completion | 1 March 2016 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- TEOSYAL® RHA Global Action
- TEOSYAL® RHA Deep Lines
Conditions studied
- Nasolabial Folds, Wrinkles — all drugs for Nasolabial Folds, Wrinkles →
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.
-
Non-inferiority of the Delta of TEOSYAL® RHA GA and TEOSYAL® RHA DL Versus Juvéderm® Ultra XC for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Blinded Live Evaluator (BLE).
Time frame: Baseline and 24 weeks after last treatment
TEOSYAL® RHA GA = TEOSYAL® RHA Global Action TEOSYAL® RHA DL = TEOSYAL® RHA Deep Lines WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale assessing wrinkle severity with 1 being 'absent' and 5 being 'extreme' BLE = Blinded Live Evaluator
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):
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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
Verify or expand the search:
- PubMed search for NCT02195427
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Nasolabial Folds, Wrinkles
Currently open trials in the same condition.
- NCT07467239 — A Prospective Clinical Investigation of DMFI300 for Treating Nasolabial Folds · NA · recruiting
Other Teoxane SA trials
Trials by the same sponsor.
- NCT06749587 — TEOSYAL RHA® 1 for the Correction of Moderate to Severe Tissue Volume Deficiency in the Infraorbital Region in Chinese A · NA · recruiting
- NCT07145905 — TCRM for Correction of Cheek Including Fine Lines · NA · active not recruiting
- NCT05986630 — Safety and Effectiveness Evaluation of TEOSYAL® TPVM Versus COMPARATOR for the Remodeling of the Lower Face · NA · active not recruiting
- NCT05133739 — RHA®4 for Midface Volume Deficiency · completed
- NCT05349799 — TEOSYAL RHA® 1 for Neck Lines, Perioral Lines and Smiling Lines · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02195427 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Teoxane SA
- Last refreshed: 26 March 2018
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