Facial Wrinkles at the Nasolabial Folds
Conditions
Keywords
nasolabial folds, facial wrinkles
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.
Interventions
DEVICEDermal Gel Extra (DGE)
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.
DEVICERestylane
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.
DRUGEMLA Cream
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.
Sponsors
Mentor Worldwide, LLC
Genzyme, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Blinded Evaluator's Assessment of Nasolabial Fold (NLF) Wrinkle Severity at Week 24 | 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
| Measure | Time frame | Description |
|---|---|---|
| Participant's Pain Assessment During the Initial Treatment Measured on a Visual Analog Scale (VAS) | Day 1 | 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). |
| Change From Baseline in the Blinded Evaluator's Assessment of Nasolabial Folds (NLF) Wrinkle Severity at Week 36 | 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. |
| 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 | 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. |
| Participant Product Preference at Week 24 | Week 24 | Participants indicated their product preference at Week 24 after Date of Optimal Correction (DOC). |
| Participant Product Preference at Week 36 | Week 36 | Participants indicated their product preference at Week 36 after Date of Optimal Correction (DOC). |
| Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | Weeks 1-36 | 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. |
| Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | weeks 36 up to 47 weeks | 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. |
Countries
United States
Participant flow
Pre-assignment details
166 subjects screened, 26 subjects were never randomized.
Participants by arm
| Arm | Count |
|---|---|
| Combined Arms Participants received DGE in one nasolabial fold (NLF) on one side of their face and Restylane in one NLF on the other side of their face (blinded, split-face study design) in the Initial Treatment. For participants who continued into the Repeat Treatment Period, they received DGE in both NLFs as an open-label treatment. | 140 |
| Total | 140 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Initial Treatment Period | Adverse Event | 1 |
| Initial Treatment Period | Lost to Follow-up | 9 |
| Initial Treatment Period | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Combined Arms |
|---|---|
| Age, Continuous | 52.7 years STANDARD_DEVIATION 9.3 |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 9 participants |
| Race/Ethnicity, Customized Asian | 1 participants |
| Race/Ethnicity, Customized Black or African American | 24 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 participants |
| Race/Ethnicity, Customized Not Available | 3 participants |
| Race/Ethnicity, Customized Other | 5 participants |
| Race/Ethnicity, Customized White | 100 participants |
| Sex: Female, Male Female | 135 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 99 / 140 | 89 / 140 | 28 / 140 | 55 / 105 | 52 / 105 | 9 / 105 |
| serious Total, serious adverse events | 0 / 140 | 0 / 140 | 1 / 140 | 0 / 105 | 0 / 105 | 1 / 105 |
Outcome results
Primary
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.
Time frame: Week 24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dermal Gel Extra (DGE) | Change From Baseline in the Blinded Evaluator's Assessment of Nasolabial Fold (NLF) Wrinkle Severity at Week 24 | 1.8 Units on a scale | Standard Deviation 1 |
| Restylane | Change From Baseline in the Blinded Evaluator's Assessment of Nasolabial Fold (NLF) Wrinkle Severity at Week 24 | 1.8 Units on a scale | Standard Deviation 1.1 |
Secondary
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.
Time frame: Week 36
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dermal Gel Extra (DGE) | Change From Baseline in the Blinded Evaluator's Assessment of Nasolabial Folds (NLF) Wrinkle Severity at Week 36 | 1.3 Units on a scale | Standard Deviation 1.2 |
| Restylane | Change From Baseline in the Blinded Evaluator's Assessment of Nasolabial Folds (NLF) Wrinkle Severity at Week 36 | 1.3 Units on a scale | Standard Deviation 1.2 |
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
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.
Time frame: Week 24
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dermal Gel Extra (DGE) | 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 Participants |
| Restylane | Number of Participants With at Least a 1 Point Improvement From Baseline in the Blinded Evaluator's Assessment of Wrinkle Severity at Week 24 | 113 Participants |
Secondary
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.
Time frame: Weeks 1-36
Population: Number of patients randomized to initial treatment phase. Safety Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Treatment - Non-drug Therapy | 32 Participants |
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Relationship - Device Related | 91 Participants |
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Severity - Mild | 47 Participants |
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | Patients with at least one Adverse Event (AE) | 99 Participants |
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Duration - less than or equal to 7 days | 70 Participants |
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | Patients with Serious AEs | 0 Participants |
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Treatment - Medication | 13 Participants |
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Duration - more than 7 days | 29 Participants |
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Severity - Severe | 15 Participants |
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Treatment - No Treatment | 54 Participants |
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | Number of Deaths | 0 Participants |
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | Patients with Baseline AEs | 0 Participants |
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Relationship - Procedure or Device | 98 Participants |
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | Patients with Study Discontinuation due to AEs | 0 Participants |
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Treatment - Hospitalization | 0 Participants |
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Relationship - Procedure Related | 69 Participants |
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Severity - Moderate | 37 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Treatment - Medication | 8 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | Patients with at least one Adverse Event (AE) | 89 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Severity - Mild | 58 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Severity - Moderate | 24 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Severity - Severe | 7 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Relationship - Procedure or Device | 87 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Relationship - Procedure Related | 61 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Relationship - Device Related | 78 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Duration - less than or equal to 7 days | 67 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Duration - more than 7 days | 22 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Treatment - No Treatment | 57 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Treatment - Non-drug Therapy | 24 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Treatment - Hospitalization | 0 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | Patients with Baseline AEs | 0 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | Patients with Serious AEs | 0 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | Patients with Study Discontinuation due to AEs | 0 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | Number of Deaths | 0 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Severity - Mild | 13 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Treatment - Non-drug Therapy | 3 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Relationship - Procedure or Device | 5 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | Number of Deaths | 0 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Treatment - Hospitalization | 1 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Severity - Severe | 5 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | Patients with Study Discontinuation due to AEs | 1 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | Patients with Baseline AEs | 0 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Severity - Moderate | 10 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | Patients with at least one Adverse Event (AE) | 28 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Duration - more than 7 days | 23 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | Patients with Serious AEs | 1 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Treatment - No Treatment | 6 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Duration - less than or equal to 7 days | 5 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Relationship - Device Related | 2 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Treatment - Medication | 18 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period | AEs by Relationship - Procedure Related | 3 Participants |
Secondary
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.
Time frame: weeks 36 up to 47 weeks
Population: Safety Population for repeat treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Relationship - Procedure or Device (DGE) | 54 Participants |
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Severity - Mild | 32 Participants |
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Severity - Moderate | 19 Participants |
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Severity - Severe | 4 Participants |
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | Patients with at least one Adverse Event (AE) | 55 Participants |
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Relationship - Procedure Related | 50 Participants |
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Relationship - Device (DGE) Related | 51 Participants |
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Duration - less than or equal to 7 days | 44 Participants |
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Duration - more than 7 days | 11 Participants |
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Treatment - No Treatment | 41 Participants |
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Treatment - Medication | 7 Participants |
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Treatment - Non-drug Therapy | 7 Participants |
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Treatment - Hospitalization | 0 Participants |
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | Patients with a Serious AEs | 0 Participants |
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | Patients with Study Discontinuation due to AEs | 0 Participants |
| Dermal Gel Extra (DGE) | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | Number of Deaths | 0 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Relationship - Procedure Related | 46 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Relationship - Device (DGE) Related | 47 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Duration - less than or equal to 7 days | 44 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | Patients with a Serious AEs | 0 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Duration - more than 7 days | 8 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Treatment - No Treatment | 40 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | Number of Deaths | 0 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Treatment - Medication | 5 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | Patients with at least one Adverse Event (AE) | 52 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | Patients with Study Discontinuation due to AEs | 0 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Severity - Mild | 34 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Treatment - Non-drug Therapy | 7 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Severity - Moderate | 15 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Severity - Severe | 3 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Relationship - Procedure or Device (DGE) | 50 Participants |
| Restylane | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Treatment - Hospitalization | 0 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Treatment - Medication | 6 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Relationship - Procedure Related | 2 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Treatment - Hospitalization | 0 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Severity - Moderate | 2 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Relationship - Device (DGE) Related | 2 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | Number of Deaths | 0 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | Patients with at least one Adverse Event (AE) | 9 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Duration - less than or equal to 7 days | 7 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Treatment - Non-drug Therapy | 0 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Relationship - Procedure or Device (DGE) | 2 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Duration - more than 7 days | 2 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | Patients with a Serious AEs | 1 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Severity - Mild | 5 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Treatment - No Treatment | 3 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | AEs by Severity - Severe | 2 Participants |
| Non-NLF | Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period | Patients with Study Discontinuation due to AEs | 0 Participants |
Secondary
Participant Product Preference at Week 24
Participants indicated their product preference at Week 24 after Date of Optimal Correction (DOC).
Time frame: Week 24
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dermal Gel Extra (DGE) | Participant Product Preference at Week 24 | 56 Participants |
| Restylane | Participant Product Preference at Week 24 | 68 Participants |
Secondary
Participant Product Preference at Week 36
Participants indicated their product preference at Week 36 after Date of Optimal Correction (DOC).
Time frame: Week 36
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dermal Gel Extra (DGE) | Participant Product Preference at Week 36 | 62 Participants |
| Restylane | Participant Product Preference at Week 36 | 55 Participants |
Secondary
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).
Time frame: Day 1
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dermal Gel Extra (DGE) | Participant's Pain Assessment During the Initial Treatment Measured on a Visual Analog Scale (VAS) | 0 time after injection | 23.2 Units on a scale | Standard Deviation 20.3 |
| Dermal Gel Extra (DGE) | Participant's Pain Assessment During the Initial Treatment Measured on a Visual Analog Scale (VAS) | 15 minutes after injection | 6.1 Units on a scale | Standard Deviation 10.1 |
| Dermal Gel Extra (DGE) | Participant's Pain Assessment During the Initial Treatment Measured on a Visual Analog Scale (VAS) | 30 minutes after injection | 3.3 Units on a scale | Standard Deviation 7 |
| Restylane | Participant's Pain Assessment During the Initial Treatment Measured on a Visual Analog Scale (VAS) | 0 time after injection | 48.9 Units on a scale | Standard Deviation 26 |
| Restylane | Participant's Pain Assessment During the Initial Treatment Measured on a Visual Analog Scale (VAS) | 15 minutes after injection | 16.3 Units on a scale | Standard Deviation 18 |
| Restylane | Participant's Pain Assessment During the Initial Treatment Measured on a Visual Analog Scale (VAS) | 30 minutes after injection | 7.9 Units on a scale | Standard Deviation 13 |