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)

NCT ID: NCT00444626

Last Updated: 2015-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2008-07-31

Brief 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).

Detailed Description

This study included an Initial and a Repeat Treatment period.

The Initial Treatment period was a subject and evaluator-blinded, randomized split face study in which subjects received DGE in one nasolabial fold and Restylane in the other nasolabial fold. Both safety and efficacy were evaluated.

In the Repeat Treatment Period, participants received DGE in both NLFs. Safety was evaluated.

Conditions

Facial Wrinkles at the Nasolabial Folds

Study Design

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

Study Groups

DGE

Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment period were treated with DGE as an open-label treatment.

Group Type: EXPERIMENTAL

Dermal Gel Extra (DGE)

Intervention Type: DEVICE

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.

EMLA Cream

Intervention Type: DRUG

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.

Restylane

Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.

Group Type: ACTIVE_COMPARATOR

Restylane

Intervention Type: DEVICE

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

Intervention Type: DRUG

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.

Interventions

Dermal Gel Extra (DGE)

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.

Intervention Type: DEVICE

Restylane

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.

Intervention Type: DEVICE

EMLA Cream

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 Type: DRUG

Other Intervention Names

PREVELLE Lift; hyaluronic acid and lidocaine; dermal filler; hyaluronic acid; lidocaine; prilocaine

Eligibility Criteria

Inclusion Criteria

• Bilateral nasolabial folds (NLF) with severity score of 3 or 4 on the 6 point scale.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mentor Worldwide, LLC

INDUSTRY

Sponsor Role: collaborator

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

Locations

Birmingham, Alabama, United States

La Jolla, California, United States

Miami Beach, Florida, United States

Westwood, New Jersey, United States

White Plains, New York, United States

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

DGE00105

Identifier Type: -

Identifier Source: org_study_id