A Study to Compare the Safety and Effectiveness of a Non-FDA Approved Device Dermal Gel Extra (DGE) and an FDA Approved Device for the Correction of Nasolabial Folds (NLFs)
Condition: Facial Wrinkles at the Nasolabial Folds
Intervention: Dermal Gel Extra (DGE); Restylane; EMLA Cream
Intervention description: Dermal Gel Extra (DGE) Injectable Gel contains hyaluronic acid with lidocaine. DGE was administered to nasolabial folds via the intradermal route. The Principal Investigator was instructed to inject a sufficient amount of DGE to ensure full correction of the NLF wrinkles (i.e., to the optimal level of correction achievable). Up to 2 touch-up treatments were allowed in the Initial Treatment period.; Restylane was administered to nasolabial folds via the intradermal route. The Principal Investigator was instructed to inject a sufficient amount of Restylane to ensure full correction of the NLF wrinkles (i.e., to the optimal level of correction achievable). Up to 2 touch-up treatments were allowed in the Initial Treatment period.; EMLA Cream (Eutectic Mixture of Local Anesthetics) is an FDA-approved topical anesthetic comprised of 2.5% each of lidocaine/prilocaine. EMLA Cream was applied in approximately equal amounts prior to all injections of DGE and Restylane.
Intervention MeSH terms: Lidocaine; Prilocaine; Lidocaine, Prilocaine Drug Combination; Hyaluronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: nasolabial folds; facial wrinkles

Summary:

      The purpose of this research study is to evaluate the safety and effectiveness of injection
      with DGE Injectable Gel (hyaluronic acid with lidocaine manufactured by Genzyme Biosurgery)
      as compared to injection with Restylane (a Food and Drug Administration (FDA) approved dermal
      filler) in patients undergoing cutaneous correction of the nasolabial folds (NLFs).
    

Eligibility criteria:

        Inclusion Criteria (abbreviated list):

          -  Bilateral nasolabial folds (NLF) with severity score of 3 or 4 on the 6 point scale.

        Exclusion Criteria (abbreviated list):

          -  Pregnant/lactating women.

          -  Subjects who have an allergy to lidocaine, prilocaine or other amide-type anesthetic.

          -  Had a chemical peel at the NLF area within 4 weeks prior to study entry. In addition,
             subjects were restricted from undergoing chemical peels at the NLF area for the
             duration of the study.

          -  Had any treatment with Botox® injections in the upper 1/3 of the face within 2 weeks
             prior to entry into the study, or in the lower 2/3 of the face within 24 weeks prior
             to entry. In addition, subjects were restricted from receiving Botox injections in the
             face for the duration of the study.

          -  Received prior therapy to the face and/or neck (e.g., dermabrasion, face-lift,
             Thermage®,laser resurfacing, contour threads, non-ablative laser treatments) within 24
             weeks prior to study entry. In addition, subjects were restricted from undergoing such
             therapy for the duration of the study.

          -  Had previous tissue augmentation at the NLF area within 24 weeks prior to study entry.
             In addition, subjects were restricted from undergoing tissue augmentation at the NLF
             area for the duration of the study.

          -  Had previous treatment at the NLF area with permanent implants (e.g.,
             silicone,Softform®) or long-lasting fillers (e.g., RadiesseTM, Sculptra®, ArteFill®
             [Artecoll], or Bio-AlcamidTM). In addition, subjects were restricted from undergoing
             treatment with permanent implants or long-lasting fillers at the NLF area for the
             duration of the study.

          -  Had evidence of scar-related disease or delayed healing activity within one year prior
             to study enrollment. (Note: subjects with scars were eligible for study enrollment,
             although scars at the intended treatment sites were not treated.)

          -  Had a history of keloid formation.

          -  Had a history of hypo- or hyperpigmentation of the skin.

          -  Had any infection, unhealed wound, or active inflammatory process (e.g., skin
             eruptions such as cysts, pimples, rashes, or hives) at the injection site(s).

          -  Immunocompromised/immunosuppressed (e.g., HIV-positive, transplant recipient, or
             presently receiving chemotherapy).