Phase 3
N=140
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)
Facial Wrinkles at the Nasolabial Folds
Bottom Line
View on ClinicalTrials.gov: NCT00444626 ↗Enrolled (actual)
140
Serious AEs
0.3%
Results posted
Apr 2015
Primary outcome: Primary: Change From Baseline in the Blinded Evaluator's Assessment of Nasolabial Fold (NLF) Wrinkle Severity at Week 24 — 1.8; 1.8 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dermal Gel Extra (DGE) (Device); Restylane (Device); EMLA Cream (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Genzyme, a Sanofi Company
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Blinded Evaluator's Assessment of Nasolabial Fold (NLF) Wrinkle Severity at Week 24 |
1.8; 1.8 | — |
| SECONDARY Participant's Pain Assessment During the Initial Treatment Measured on a Visual Analog Scale (VAS) |
23.2; 48.9; 6.1; 16.3; 3.3; 7.9 | — |
| SECONDARY Change From Baseline in the Blinded Evaluator's Assessment of Nasolabial Folds (NLF) Wrinkle Severity at Week 36 |
1.3; 1.3 | — |
| SECONDARY Number of Participants With at Least a 1 Point Improvement From Baseline in the Blinded Evaluator's Assessment of Wrinkle Severity at Week 24 |
114; 113 | — |
| SECONDARY Participant Product Preference at Week 24 |
56; 68 | — |
| SECONDARY Participant Product Preference at Week 36 |
62; 55 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period |
99; 89; 28; 47; 58; 13 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period |
55; 52; 9; 32; 34; 5 | — |
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).
Data sourced from ClinicalTrials.gov (NCT00444626). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.