TEOSYAL® RHA Ultra Deep and Perlane-L® for the Correction of Nasolabial Folds

Teoxane SA140 enrolled

Overview

The purpose of this study is to compare the effectiveness and safety of TEOSYAL® RHA Ultra Deep versus Perlane-L® in the treatment of moderate to severe nasolabial folds. This is a controlled, randomized, double-blinded, within subject (split-face), multicenter, prospective clinical study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

140

Conditions

Nasolabial Folds, Wrinkles

Interventions

TEOSYAL® RHA Ultra DeepDEVICE

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 27Gauge ½" disposable sterile needles.

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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 form. Exclusion Criteria: * Female subjects that are pregnant, 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, ASA, 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). * Evidence of 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.

Locations (4)

United States

Beverly Hills, California, United States

United States

Bradenton, Florida, United States

United States

Chapel Hill, North Carolina, United States

United States

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Non-inferiority of the Delta of the WSRS Score Between W24 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe Naso-Labial Folds Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the BLE.

WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being 'absent' and 5 being 'extreme'. BLE =Blinded Live Evaluator

Time frame: Baseline and 24 weeks after last treatment

Secondary Outcomes

Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L®

The subjects received a diary booklet and instructions for recording his/her observations of the Common Treatment Responses of the study treatments for the first 14 days after each treatment (initial, touch-up). The diary was discussed during each telephone follow-up visit. Subjects should complete the diary at approximately the same time each day (i.e., am or pm). The subject diary captured the following Common Treatment Responses (CTR) that occur following the injection of a dermal filler; specifically, redness, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching, discoloration, and "other". The 14-day patient CTR diary included a detailed glossary describing all signs/symptoms listed in the diary; an option was provided to rate "other" if the subject experienced a sign/symptom that is not listed. The table presents the number of subjects experiencing at least 1 Common Treatment Response (CTR)

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

Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L®

VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain

Time frame: During Injection and 5, 15, 30 minutes post-injection

Delta of the WSRS Score Between W24,36,52 and 64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Blinded Live Evaluator (BLE)

Data from ClinicalTrials.gov

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