A Study to Compare the Safety and Effectiveness of a Non-FDA Approved Device (DGE) and an FDA Approved Device for the Correction of Nasolabial Folds (NLFs)
This study has been completed.
Sponsor:
Genzyme
Collaborator:
Mentor Worldwide, LLC
Information provided by:
Genzyme
ClinicalTrials.gov Identifier:
NCT00444626
First received: March 7, 2007
Last updated: May 14, 2010
Last verified: March 2007
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Purpose
The purpose of this research study is to evaluate the safety and effectiveness of injection with DGE Injectable Gel (manufactured by Genzyme Biosurgery) as compared to injection with a Food and Drug Administration (FDA) approved dermal filler in patients undergoing cutaneous correction of the nasolabial folds (NLFs).
| Condition | Intervention | Phase |
|---|---|---|
|
Facial Wrinkles at the Nasolabial Folds |
Device: Dermal Gel Extra (DGE) Device: Restylane |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Genzyme:
Primary Outcome Measures:
- Mean Change from Baseline in the Blinded Evaluator's Assessment of Nasolabial Fold (NLF) Wrinkle Severity at Week 24 [ Time Frame: week 24 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Participant's Pain Assessment During the Initial Treatment Measured on a Visual Analog Scale (VAS) [ Time Frame: day 1 ] [ Designated as safety issue: No ]
- Change from Baseline in the Blinded Evaluator's Assessment of NLF Wrinkle Severity at Week 36 [ Time Frame: week 36 ] [ Designated as safety issue: No ]
- Number of Participants with at least a 1 point Improvement from Baseline in the Blinded Evaluator's Assessment of Wrinkle Severity at Week 24 [ Time Frame: week 24 ] [ Designated as safety issue: No ]
- Participant Product Preference at Week 24 [ Time Frame: week 24 ] [ Designated as safety issue: No ]
- Participant Product Preference at Week 36 [ Time Frame: week 36 ] [ Designated as safety issue: No ]
- Summary of Safety during the Initial Treatment Period [ Time Frame: weeks 0-36 ] [ Designated as safety issue: No ]
- Summary of Safety during the Repeat Treatment Period [ Time Frame: weeks 36-47 ] [ Designated as safety issue: No ]
| Enrollment: | 140 |
| Study Start Date: | May 2007 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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. For those that continued into the Repeat Treatment Period, they received DGE in all NLFs as an open-label treatment.
|
Device: Dermal Gel Extra (DGE)
Dermal Gel Extra (DGE) Injectable Gel was administered only to the 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).
Other Names:
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Active Comparator: 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.
|
Device: Restylane
Restylane was administered only to the 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).
Other Names:
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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.
In the Repeat Treatment Period, participants received DGE in both NLFs.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria (abbreviated list):
- Bilateral nasolabial folds 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 1 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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00444626
Locations
| United States, Alabama | |
| Birmingham, Alabama, United States, 35205 | |
| United States, California | |
| La Jolla, California, United States, 92037 | |
| United States, Florida | |
| Miami Beach, Florida, United States, 33140 | |
| United States, New Jersey | |
| Westwood, New Jersey, United States, 07675 | |
| United States, New York | |
| White Plains, New York, United States, 10640 | |
| United States, Tennessee | |
| Nashville, Tennessee, United States, 37215 | |
Sponsors and Collaborators
Genzyme
Mentor Worldwide, LLC
Investigators
| Study Director: | Medical Monitor | Genzyme |
More Information
No publications provided
| Responsible Party: | Medical Monitor, Genzyme Corporation |
| ClinicalTrials.gov Identifier: | NCT00444626 History of Changes |
| Other Study ID Numbers: | DGE00105 |
| Study First Received: | March 7, 2007 |
| Last Updated: | May 14, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hyaluronic Acid Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013