Clinical trial NCT02253147: TEOSYAL® RHA Ultra Deep and Perlane-L® for the Correction of Nasolabial Folds
Official title: A Controlled, Randomized, Double-Blinded, Within-Subject, Multicenter, Prospective Clinical Study of TEOSYAL® RHA (Resilient Hyaluronic Acid) Ultra Deep Versus Perlane-L® in the Treatment of Moderate to Severe Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasolabial Folds, Wrinkles
Keywords: Nasolabial folds
Dermal filler
Hyaluronic acid (HA)
Wrinkles
Lead sponsor: Teoxane SA
Sponsor class: INDUSTRY
Collaborators: name: ethica Clinical Research Inc.
First posted: 2014-10-01
Enrollment: 140
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 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.

Primary outcomes:
measure: 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.
timeFrame: Baseline and 24 weeks after last treatment
Secondary outcomes:
measure: Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
timeFrame: During 14 days after initial treatment (D0) and touch-up (2 weeks)
measure: Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
timeFrame: During Injection and 5, 15, 30 minutes post-injection
measure: 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)
timeFrame: Baseline and Weeks 24, 36, 52, 64
measure: 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)
timeFrame: Baseline and Weeks 2, 4, 12, 24, 36, 52, 64
measure: 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
timeFrame: Baseline and Weeks 24, 36, 52, 64
measure: 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
timeFrame: Baseline and Weeks 2, 4, 12, 24, 36, 52, 64
measure: Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) by the Blinded Live Evaluator (BLE)
timeFrame: Weeks 24, 36, 52, 64
measure: Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either "Much Improved" or "Improved") on GAI Scale.
timeFrame: Weeks 4, 12, 24, 36, 52, 64
measure: Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire
timeFrame: Immediately post-injection, and weeks 2, 4, 12, 24, 36, 52, 64
measure: Subject's Satisfaction Score
timeFrame: Weeks 2, 4, 12, 24, 36, 52, 64
measure: Volume to Obtain Optimal Cosmetic Result (Initial Treatment + Touch-up)
timeFrame: Week 2
measure: Number of Subjects Receiving Touch-up Treatment
timeFrame: Week 2
measure: Number of Subjects Receiving Re-treatment
timeFrame: Weeks 24, 36, 52, 64
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: United States
state: California
city: Bradenton
country: United States
facility: United States
state: Florida
city: Chapel Hill
country: United States
facility: United States
state: North Carolina
city: Philadelphia
country: United States
facility: United States
state: Pennsylvania
Study officials:
References: