N/A N=147 Randomized Double-blind Treatment

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

Nasolabial Folds, Wrinkles

Bottom Line

View on ClinicalTrials.gov: NCT02195427 ↗

Enrolled (actual)

147

Serious AEs

1.3%

Results posted

Mar 2018

Primary outcome: Primary: 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). — -1.16; -1.13; -1.32; -1.23 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: TEOSYAL® RHA Global Action (Device); TEOSYAL® RHA Deep Lines (Device)
Age: Adult, Older Adult · 22+ yrs
Sex: All
Sponsor: Teoxane SA
Primary completion: Mar 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY 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).	-1.16; -1.13; -1.32; -1.23	—
SECONDARY 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).	36; 41; 42; 38; 15; 13	—
SECONDARY 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).	15.0; 13.9; 16.7; 14.6; 3.8; 3.9	—
SECONDARY 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	-1.16; -1.13; -1.32; -1.23; -1.12; -1.12	—
SECONDARY 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	-1.49; -1.34; -1.45; -1.31; -1.66; -1.69	—
SECONDARY Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the WSRS Compared to Baseline Assessed by the BLE	83.6; 82.1; 91.9; 88.7; 86.2; 87.7	—
SECONDARY Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the WSRS Compared to Baseline Assessed by the TI	98.5; 91.0; 95.2; 93.6; 98.5; 98.5	—
SECONDARY Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE).	61; 59; 59; 58; 60; 61	—
SECONDARY Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either "Much Improved" or "Improved") on GAI Scale.	64; 63; 59; 59; 60; 59	—
SECONDARY Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire	24.7; 25.2; 29.1; 27.7; 70.3; 69.0	—
SECONDARY Subject's Satisfaction Score	1.58; 1.57; 1.87; 1.81; 1.29; 1.29	—
SECONDARY Volume to Obtain Optimal Cosmetic Result (Initial Treatment + Touch-up)	1.54; 1.30; 1.52; 1.30	—
SECONDARY Number of Subjects Receiving Touch-up Treatment.	43; 45; 45; 47	—
SECONDARY Number of Subjects Receiving Re-treatment	1; 1; 0; 0; 3; 3	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02195427). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.