Facial Wrinkles at the Nasolabial FoldsPhase 3NCT00444626

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)

A Phase 3 study testing Dermal Gel Extra (DGE), Restylane and EMLA Cream in people with Facial Wrinkles at the Nasolabial Folds, run by Genzyme, a Sanofi Company at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Facial Wrinkles at the Nasolabial Folds
What is being tested?: Dermal Gel Extra (DGE), Restylane and EMLA Cream
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: 6 sitesUnited States
Study dates: May 2007to Jul 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

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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).

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Study site
Birmingham, Alabama, 35205
Study site
La Jolla, California, 92037
Study site
Miami Beach, Florida, 33140
Study site
Nashville, Tennessee, 37215
Study site
Westwood, New Jersey, 07675
Study site
White Plains, New York, 10640

Other trials in United States

About this study

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

Read the 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
Being tested: Dermal Gel Extra (DGE), Restylane, EMLA Cream
Keywords: nasolabial folds, facial wrinkles

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dermal Gel Extra (DGE)Device
Also called PREVELLE Lift, hyaluronic acid and lidocaine
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.
RestylaneDevice
Also called dermal filler, hyaluronic acid
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 CreamDrug
Also called lidocaine, prilocaine
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.

Study groups in NCT00444626
Study group	Role	What they receive
DGE	Experimental	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. Receives: Device: Dermal Gel Extra (DGE); Drug: EMLA Cream
Restylane	Active comparator	Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Receives: Device: Restylane; Drug: EMLA Cream

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in the Blinded Evaluator's Assessment of Nasolabial Fold (NLF) Wrinkle Severity at 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.
Measured: Week 24

Secondary outcomes (7)

Participant's Pain Assessment During the Initial Treatment Measured on a Visual Analog Scale (VAS)
The pain experienced by each participant at the time of injection (time 0) and at 15 and 30 minutes after injection during the initial treatment visit was evaluated. Pain was measured using a VAS of 0 mm (no pain) to 100 mm (extreme pain).
Measured: Day 1
Change From Baseline in the Blinded Evaluator's Assessment of Nasolabial Folds (NLF) Wrinkle Severity at Week 36
Mean change between Baseline and the Week 36 score (Baseline minus week 36 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.
Measured: Week 36
Number of Participants With at Least a 1 Point Improvement From Baseline in the Blinded Evaluator's Assessment of Wrinkle Severity at Week 24
Count of participants with at least a 1-point improvement from Baseline in the Genzyme 6-Point Grading Scale (GGS) at Week 24. A GGS score of zero indicates no wrinkles and a score of 5 indicates very deep wrinkles with redundant folds.
Measured: Week 24
Participant Product Preference at Week 24
Participants indicated their product preference at Week 24 after Date of Optimal Correction (DOC).
Measured: Week 24
Participant Product Preference at Week 36
Participants indicated their product preference at Week 36 after Date of Optimal Correction (DOC).
Measured: Week 36
Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period
Counts of participants with treatment-emergent adverse events (AEs) from the time of injection up to Week 36. AEs are presented regardless of relationship to study device and/or procedure.
If a participant had more than one occurrence of the same AE, he/she was counted only once. The most severe occurrence of an AE, as well as the most extreme relationship of the AE to the device, was indicated in cases of multiple occurrences of the same AE. For AEs by relationship, procedure-related and device-related AEs are not mutually exclusive and therefore are not additive.
Measured: Weeks 1-36
Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period
Count of participants with treatment-emergent adverse events (AEs) from the time of injection for the repeat treatment period up to week 47. AEs are presented regardless of relationship to study device and/or procedure.
If a participant had more than one occurrence of the same AE, he/she was counted only once. The most severe occurrence of an AE, as well as most extreme relationship of the AE to the device, was indicated in cases of multiple occurrences of the same AE. For AEs by relationship, procedure-related and device-related AEs are not mutually exclusive and therefore are not additive.
Measured: weeks 36 up to 47 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2007Jul 2008

First posted8 Mar 2007 (estimated)
Study startMay 2007
Primary completionFeb 2008
Study completionJul 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Facial Wrinkles at the Nasolabial FoldsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00444626
Sponsor's protocol ID: DGE00105
Status last verified: Apr 2015
First submitted: 7 Mar 2007
Last updated: 22 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00444626
Acronym / sponsor ID: DGE00105
Conditions: Facial Wrinkles at the Nasolabial Folds
Keywords: nasolabial folds, facial wrinkles
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
Collaborators: Mentor Worldwide, LLC
Study start: May 2007
Primary completion: Feb 2008 (actual)
Study completion: Jul 2008 (actual)
First posted: 8 Mar 2007 (estimated)
Results: Posted 22 Apr 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study included an Initial and a Repeat Treatment period.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
DGE	Experimental	Device: Dermal Gel Extra (DGE), Drug: EMLA CreamParticipants 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.
Restylane	Active comparator	Device: Restylane, Drug: EMLA CreamParticipants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dermal Gel Extra (DGE)Also: PREVELLE Lift, hyaluronic acid and lidocaineDermal 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.	Device	DGE
RestylaneAlso: dermal filler, hyaluronic acidRestylane 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.	Device	Restylane
EMLA CreamAlso: lidocaine, prilocaineEMLA 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.	Drug	DGE, Restylane

Primary outcome

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.

7 secondary outcomes

Participant's Pain Assessment During the Initial Treatment Measured on a Visual Analog Scale (VAS)
Time frame: Day 1
Change From Baseline in the Blinded Evaluator's Assessment of Nasolabial Folds (NLF) Wrinkle Severity at Week 36
Time frame: Week 36
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
Participant Product Preference at Week 24
Time frame: Week 24
Participant Product Preference at Week 36
Time frame: Week 36
Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period
Time frame: Weeks 1-36
Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period
Time frame: weeks 36 up to 47 weeks

Results and safety

Results posted to the registry on 22 Apr 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Combined Arm	140	128

Primary outcome: Change From Baseline in the Blinded Evaluator's Assessment of Nasolabial Fold (NLF) Wrinkle Severity at Week 24

Time frame: Week 24. Mean (Standard Deviation). Unit: Units on a scale

Measure	Dermal Gel Extra (DGE) n = 129	Restylane n = 129
Value	1.8 (1.0)	1.8 (1.1)

Population analysed: The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dermal Gel Extra (DGE): Initial Treatment Period	0 of 140 (0%)	99 of 140 (70.7%)	Not reported
Restylane: Initial Treatment Period	0 of 140 (0%)	89 of 140 (63.6%)	Not reported
Non-NLF: Initial Treatment Period	1 of 140 (0.7%)	28 of 140 (20%)	Not reported
Dermal Gel Extra (DGE) - Repeat Treatment Period	0 of 105 (0%)	55 of 105 (52.4%)	Not reported
Restylane - Dermal Gel Extra (DGE) - Repeat Treatment Period	0 of 105 (0%)	52 of 105 (49.5%)	Not reported
Non-NLF: Repeat Treatment Period	1 of 105 (1%)	9 of 105 (8.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Genzyme, a Sanofi Company

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dermal Gel Extra (DGE), Restylane and EMLA Cream in people with Facial Wrinkles at the Nasolabial Folds, run by Genzyme, a Sanofi Company at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Blinded Evaluator's Assessment of Nasolabial Fold (NLF) Wrinkle Severity at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00444626.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2015.