TEOSYAL® RHA Global Action, TEOSYAL® RHA Deep Lines, and Juvéderm® Ultra XC for the Correction of Nasolabial Folds

NCT02195427 | Completed Results

• 1 other identifier: TEO-RHA-1302
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Nasolabial Folds, Wrinkles

Keywords

Nasolabial folds; Dermal filler; Hyaluronic acid (HA); Wrinkles

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  Baseline and 24 weeks after last treatment

Secondary Outcomes (13)

• Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).

  During 14 days after initial treatment (D0) and touch-up (2 weeks)

• Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).

  During Injection and 5, 15, 30 minutes post-injection

• Delta of the WSRS Score Between W24,36,52 and Baseline for TEOSYAL® RHA GA Versus Juvéderm® Ultra XC and TEOSYAL® RHA DL Versus Juvéderm® Ultra XC for the Correction of Moderate to Severe NLFs Based on the WSRS Score Assessed by the BLE

  Baseline and Weeks 24, 36, 52, 64

• Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA GA Versus Juvéderm® Ultra XC and TEOSYAL® RHA Deep Lines Versus Juvéderm® Ultra XC for the Correction of Moderate to Severe NLFs Based on the WSRS Score Assessed by the TI

  Baseline and Weeks 2, 4, 12, 24, 36, 52, 64

• Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the WSRS Compared to Baseline Assessed by the BLE

  Baseline and Weeks 24, 36, 52, 64

Study Arms (2)

TEOSYAL RHA Global Action/Juvederm Ultra XC

EXPERIMENTAL

Split-face injection of TEOSYAL® RHA Global Action into one NLF and Juvederm® Ultra XC into the contralateral NLF (n=75). Up to 3.0 mL injected per NLF (mid-dermis to deep-dermis). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).

Device: TEOSYAL® RHA Global Action

TEOSYAL RHA Deep Lines/Juvederm Ultra XC

EXPERIMENTAL

Split-face injection of TEOSYAL® RHA Deep Lines into one NLF and Juvederm® Ultra XC into the contralateral NLF (n=75). Up to 3.0 mL injected per NLF (mid-dermis to deep-dermis). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).

Device: TEOSYAL® RHA Deep Lines

Interventions

TEOSYAL® RHA Global Action DEVICE

A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 30G1/2" disposable sterile needles.

TEOSYAL RHA Global Action/Juvederm Ultra XC

TEOSYAL® RHA Deep Lines DEVICE

A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 27G1/2" disposable sterile needles.

TEOSYAL RHA Deep Lines/Juvederm Ultra XC

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatient, male or female of any race, 22 years of age or older; female subjects of childbearing potential must have a negative urine pregnancy test and practice a reliable method of contraception
• NLFs classified as WSRS grade 3 or 4 (same score for each side)
• Willing to abstain from facial aesthetic procedures/therapies that could interfere with study evaluations
• Able to follow study instructions and likely to complete all required visits;
• Signed informed consent and HIPAA (Health Insurance Portability and Accountability Act) form

You may not qualify if:

• Female subjects that are pregnant or breast-feeding, or of childbearing potential and not practicing reliable birth control
• Known hypersensitivity/allergy to any component of the study devices
• Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, history of anaphylactic shock
• Known susceptibility to keloid formation, hypertrophic scarring or clinically significant skin pigmentation disorders
• Clinically significant active skin disease within 6 months
• History of active chronic debilitating systemic disease
• History of connective tissue disease
• History of malignancy (excl. non-melanoma skin cancer) within past 5 years
• History of bleeding disorders
• Need for clinically significant and continuous medical treatment within 2 weeks prior to first visit
• Received/used a prohibited treatment/procedure within certain time periods (e.g., bioresorbable fillers, NSAIDS, acetylsalicylic acid, high dose vitamin E, corticosteroids, interferon, anti-coagulation therapies, laser/light therapies, botulinum toxin injections (frontalis and glabella complex treatment permitted), prescription strength topical retinoids, facial peels, excisional facial surgery, clinically significant oral or maxillofacial surgery)
• Clinically significant alcohol or drug abuse, or history of poor cooperation, non-compliance with medical treatment, or unreliability
• Exhibit a physical attribute(s) that may prevent assessment or treatment of NLFs such as excessive facial hair, traumatic or surgical facial scars, and/or excessive hyperpigmentation in the treatment areas
• A condition or situation that may put the subject at significant risk, confound the study results, or significantly interfere with the subject participation

Sponsors & Collaborators

• Teoxane SA: lead
• ethica Clinical Research Inc.: collaborator

Study Sites (5)

United States, Alabama

Birmingham, Alabama, United States

Location

United States, California

Beverly Hills, California, United States

Location

United States, Santa Monica

Santa Monica, California, United States

Location

United States, Florida

Coral Gables, Florida, United States

Location

United States, Massachusetts

Chestnut Hill, Massachusetts, United States

Location

Results Point of Contact

• Title: Clinical Project Manager
• Organization: Teoxane

m.chenet@teoxane.com

+41 (0) 22 344 96 36

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: July 21, 2014
• Study Start: June 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2016
• Last Updated: April 25, 2018
• Results First Posted: March 26, 2018

Record last verified: 2018-03

Locations

US (5)