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
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Genzyme, a Sanofi Company
- Enrollment
- 140
- Primary Endpoint
- Change From Baseline in the Blinded Evaluator's Assessment of Nasolabial Fold (NLF) Wrinkle Severity at Week 24
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Dermal Gel Extra (DGE) (Device)
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.
Intervention: EMLA Cream (Drug)
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.
Intervention: Restylane (Device)
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.
Intervention: EMLA Cream (Drug)
Outcomes
Primary Outcomes
Change From Baseline in the Blinded Evaluator's Assessment of Nasolabial Fold (NLF) Wrinkle Severity at Week 24
Time Frame: Week 24
This was a comparison of the mean change between Baseline and the Week 24 score (baseline minus week 24 scores) in the blinded evaluators' assessments of NLF wrinkle severity. A positive value for the mean change indicates an improvement. Genzyme 6-Point Grading Scale (GGS) for NLF was used for the assessment. A GGS score of zero indicates no wrinkles and a score of 5 indicates very deep wrinkles with redundant folds.
Secondary Outcomes
- Change From Baseline in the Blinded Evaluator's Assessment of Nasolabial Folds (NLF) Wrinkle Severity at Week 36(Week 36)
- Participant's Pain Assessment During the Initial Treatment Measured on a Visual Analog Scale (VAS)(Day 1)
- Participant Product Preference at Week 24(Week 24)
- Number of Participants With at Least a 1 Point Improvement From Baseline in the Blinded Evaluator's Assessment of Wrinkle Severity at Week 24(Week 24)
- Participant Product Preference at Week 36(Week 36)
- Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period(Weeks 1-36)
- Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period(weeks 36 up to 47 weeks)