Clinical trial NCT00444626: 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)
Official title: A Subject- and Evaluator-Blinded, Randomized, Multi-Center Study to Evaluate the Safety and Effectiveness of Injection With DGE Injectable Gel as Compared to an FDA-Approved Dermal Filler in Subjects Undergoing Cutaneous Correction of Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Facial Wrinkles at the Nasolabial Folds
Keywords: nasolabial folds
facial wrinkles
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Mentor Worldwide, LLC
First posted: 2007-03-08
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Change From Baseline in the Blinded Evaluator's Assessment of Nasolabial Fold (NLF) Wrinkle Severity at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Participant's Pain Assessment During the Initial Treatment Measured on a Visual Analog Scale (VAS)
timeFrame: Day 1
measure: Change From Baseline in the Blinded Evaluator's Assessment of Nasolabial Folds (NLF) Wrinkle Severity at Week 36
timeFrame: Week 36
measure: Number of Participants With at Least a 1 Point Improvement From Baseline in the Blinded Evaluator's Assessment of Wrinkle Severity at Week 24
timeFrame: Week 24
measure: Participant Product Preference at Week 24
timeFrame: Week 24
measure: Participant Product Preference at Week 36
timeFrame: Week 36
measure: Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period
timeFrame: Weeks 1-36
measure: Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period
timeFrame: weeks 36 up to 47 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: La Jolla
country: United States
state: California
city: Miami Beach
country: United States
state: Florida
city: Westwood
country: United States
state: New Jersey
city: White Plains
country: United States
state: New York
city: Nashville
country: United States
state: Tennessee
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References: