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

Teoxane

Status: Completed

Conditions: Nasolabial Folds, Wrinkles

Treatments: Device: TEOSYAL® RHA Global Action; Device: TEOSYAL® RHA Deep Lines

Study type: Interventional

Funder types: Industry

Identifiers

NCT02195427

TEO-RHA-1302

Details and patient eligibility

About

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.

Enrollment: 148 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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148 participants in 2 patient groups

TEOSYAL RHA Global Action/Juvederm Ultra XC

Experimental group

Description:

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).

Treatment:

Device: TEOSYAL® RHA Global Action

TEOSYAL RHA Deep Lines/Juvederm Ultra XC

Experimental group

Description:

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).

Treatment:

Device: TEOSYAL® RHA Deep Lines