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

Teoxane

Status: Completed

Conditions: Nasolabial Folds, Wrinkles

Treatments: Device: TEOSYAL® RHA Ultra Deep

Study type: Interventional

Funder types: Industry

Identifiers

NCT02253147

TEO-RHA-1402

Details and patient eligibility

About

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.

Enrollment: 140 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups

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

Experimental group

Description:

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).

Treatment:

Device: TEOSYAL® RHA Ultra Deep

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

Experimental group

Description:

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).

Treatment:

Device: TEOSYAL® RHA Ultra Deep