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

NCT ID: NCT02253147

Last Updated: 2018-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-05-31

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.

Conditions

Nasolabial Folds, Wrinkles

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Left side TEOSYAL® RHA Ultra Deep, Right side Perlane-L®

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).

Group Type: EXPERIMENTAL

TEOSYAL® RHA Ultra Deep

Intervention Type: DEVICE

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.

Left side Perlane-L®, Right side 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).

Group Type: EXPERIMENTAL

TEOSYAL® RHA Ultra Deep

Intervention Type: DEVICE

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.

Interventions

TEOSYAL® RHA Ultra Deep

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ethica Clinical Research Inc.

INDUSTRY

Sponsor Role: collaborator

Teoxane SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

Other Identifiers

TEO-RHA-1402

Identifier Type: -

Identifier Source: org_study_id