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

Not Applicable

Completed

Conditions: Nasolabial Folds, Wrinkles

Interventions: Device: TEOSYAL® RHA Ultra Deep

Registration Number: NCT02253147

Lead Sponsor: Teoxane SA

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 140

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Left side TEOSYAL® RHA Ultra Deep, Right side Perlane-L®	TEOSYAL® RHA Ultra Deep	Split-face injection of TEOSYAL® RHA Ultra Deep into the left Naso Labial Folds (NLFs) and Perlane-L® into the right NLF (n=120). Up to 3.0 mL injected per NLF. Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).
Left side Perlane-L®, Right side TEOSYAL® RHA Ultra Deep	TEOSYAL® RHA Ultra Deep	Split-face injection of Perlane-L® into the left Naso Labial Folds (NLFs) and TEOSYAL® RHA Ultra Deep into the right NLF (n=120). Up to 3.0 mL injected per NLF. Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).

Primary Outcome Measures

Name	Time	Method
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.	Baseline and 24 weeks after last treatment	WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being 'absent' and 5 being 'extreme'. BLE =Blinded Live Evaluator

Secondary Outcome Measures

Name	Time	Method
Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L®	During 14 days after initial treatment (D0) and touch-up (2 weeks)	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)
Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L®	During Injection and 5, 15, 30 minutes post-injection	VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain
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)	Baseline and Weeks 24, 36, 52, 64	WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being 'absent' and 5 being 'extreme'.
Delta of the WSRS Score Between W2,4,12,24,36,52,64 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 Treating Investigator (TI)	Baseline and Weeks 2, 4, 12, 24, 36, 52, 64	WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being 'absent' and 5 being 'extreme'.
Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the BLE	Baseline and Weeks 24, 36, 52, 64	A responder correspond to a subject with an intra-individual improvement of at least one grade in the WSRS compared to Baseline
Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the TI	Baseline and Weeks 2, 4, 12, 24, 36, 52, 64	A responder correspond to a subject with an intra-individual improvement of at least one grade in the WSRS compared to baseline
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) by the Blinded Live Evaluator (BLE)	Weeks 24, 36, 52, 64	Global Aesthetic Improvement (GAI) is a subjective 5-grade scale comprised of "much improved, improved, no change, worse, and much worse". GAI was assessed using the baseline photograph. Each side of the face was assessed independently.
Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either "Much Improved" or "Improved") on GAI Scale.	Weeks 4, 12, 24, 36, 52, 64	Global Aesthetic Improvement (GAI) is a subjective 5-grade scale comprised of "much improved, improved, no change, worse, and much worse". GAI was assessed using the baseline photograph. Subjects will be instructed: "Use a mirror to compare your face to the photograph provided to you and rate the degree of aesthetic improvement by using the following scale". Each side of the face was assessed independently.
Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire	Immediately post-injection, and weeks 2, 4, 12, 24, 36, 52, 64	The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective. FACE-Q questionnaire is composed of 5 questions with a score linked to answers (1 being 'Not at all' and 4 being 'Extremely'). The subject was instructed as follows: "These questions ask about how you look right now. With your nasolabial folds in mind (the deep lines that run downward from the sides of your nose), in the past week, how much have you been bothered by:", and provided response. * How deep your nasolabial fold are? * How your nasolabial folds look when your face is relaxed (still)? * How old your nasolabial folds make you look? * How your nasolabial folds look when you smile? * How your nasolabial folds look compared with other people your age? To calculate the FACE-Q, outcomes from all 5 questions were pooled and adapted to a scale to 100 units. Data were also transformed so that higher scores reflected a beneficial outcome.
Subject's Satisfaction Score	Weeks 2, 4, 12, 24, 36, 52, 64	Subjective 5-point scale with 1 being 'very satisfied' and 5 being 'very dissatisfied'
Volume to Obtain Optimal Cosmetic Result (Initial Treatment + Touch-up)	Week 2
Number of Subjects Receiving Touch-up Treatment	Week 2
Number of Subjects Receiving Re-treatment	Weeks 24, 36, 52, 64