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| Name | Class |
|---|---|
| Mentor Worldwide, LLC | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dermal Gel Extra (DGE) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 1 |
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Inclusion Criteria (abbreviated list):
Exclusion Criteria (abbreviated list):
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35205 | United States | |||
166 subjects screened, 26 subjects were never randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Combined Arm | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Initial Treatment Period |
|
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| Restylane | Device | 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. |
|
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| EMLA Cream | Drug | 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. |
|
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| 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. | 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. | Week 24 |
| Participant Product Preference at Week 24 | Participants indicated their product preference at Week 24 after Date of Optimal Correction (DOC). | Week 24 |
| Participant Product Preference at Week 36 | Participants indicated their product preference at Week 36 after Date of Optimal Correction (DOC). | 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. | 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. | weeks 36 up to 47 weeks |
| La Jolla |
| California |
| 92037 |
| United States |
| Miami Beach | Florida | 33140 | United States |
| Westwood | New Jersey | 07675 | United States |
| White Plains | New York | 10640 | United States |
| Nashville | Tennessee | 37215 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| Repeat Treatment Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Multiple responses were possible for race as the screening visit CRF stated "check all that apply". | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Week 24 | nasolabial folds | Participants |
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| 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). | 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. | Posted | Mean | Standard Deviation | Units on a scale | Day 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Week 36 | nasolabial folds | Participants |
| ||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | Participants | Week 24 |
| |||||||||||||||||||||||||||||||||
| Secondary | Participant Product Preference at Week 24 | Participants indicated their product preference at Week 24 after Date of Optimal Correction (DOC). | 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. | Posted | Number | Participants | Week 24 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Participant Product Preference at Week 36 | Participants indicated their product preference at Week 36 after Date of Optimal Correction (DOC). | 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. | Posted | Number | Participants | Week 36 |
|
| ||||||||||||||||||||||||||||||||
| 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. | Number of patients randomized to initial treatment phase. Safety Population. | Posted | Number | Participants | Weeks 1-36 |
| |||||||||||||||||||||||||||||||||
| 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. | Safety Population for repeat treatment. | Posted | Number | Participants | weeks 36 up to 47 weeks |
|
Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47)
Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dermal Gel Extra (DGE): Initial Treatment Period | Adverse events that occurred at the nasolabial fold treated with DGE, and occurred during the Initial Treatment Period regardless of relationship to DGE treatment. | 0 | 140 | 99 | 140 | ||
| EG001 | Restylane: Initial Treatment Period | Adverse events that occurred at the nasolabial fold treated with Restylane, and occurred during the Initial Treatment Period regardless of relationship to Restylane treatment. | 0 | 140 | 89 | 140 | ||
| EG002 | Non-NLF: Initial Treatment Period | Adverse events that did not occur at the nasolabial folds, and occurred during the Initial Treatment Period regardless to relationship to either DGE or Restylane treatment. | 1 | 140 | 28 | 140 | ||
| EG003 | Dermal Gel Extra (DGE) - Repeat Treatment Period | Adverse events that occurred at the nasolabial fold that was treated with DGE in the Initial Treatment Period, and occurred during the Repeat Treatment Period regardless of relationship to DGE treatment. | 0 | 105 | 55 | 105 | ||
| EG004 | Restylane - Dermal Gel Extra (DGE) - Repeat Treatment Period | Adverse events that occurred at the nasolabial fold that was treated with Restylane in the Initial Treatment Period, and occurred during the Repeat Treatment Period regardless of relationship to DGE treatment. | 0 | 105 | 52 | 105 | ||
| EG005 | Non-NLF: Repeat Treatment Period | Adverse events that did not occur at the nasolabial folds, and occurred during the Repeat Treatment Period regardless to relationship to DGE treatment. | 1 | 105 | 9 | 105 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment | Reported by investigator as unrelated to study device. |
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| Gastric ulcer | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | Reported by investigator as unrelated to study device. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site swelling | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Injection site bruising | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Injection site nodule | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Injection site anaesthesia | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Injection site paraesthesia | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Injection site discolouration | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Injection site discomfort | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Injection site dryness | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Injection site haemorrhage | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Injection site inflammation | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Injection site papule | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Cyst | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Onychomycosis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Injection site pustule | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Open wound | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Post procedural diarrhoea | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Post procedural swelling | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Postoperative constipation | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Procedural nausea | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Resorption bone increased | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Localised intraabdominal fluid collection | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Oral disorder | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Stomach discomfort | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Duodenitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Lip swelling | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Sinus headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Allergy to arthropod bite | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
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| Bone density decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
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| Intraocular pressure increased | Investigations | MedDRA (10.0) | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Postnasal drip | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Blister | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Vitreous floaters | Eye disorders | MedDRA (10.0) | Systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
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| Menorrhagia | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
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| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
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Principal investigators (PI) will give Genzyme a draft manuscript or draft publication 60 days before publication. Genzyme will make every reasonable attempt to review publication or manuscript and give feedback in such 60 day period. PI will not use Genzyme confidential information without prior written consent.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Genzyme Medical Information (MedInfo) | Genzyme | medinfo@genzyme.com |
| ID | Term |
|---|---|
| D000077442 | Lidocaine, Prilocaine Drug Combination |
| D008012 | Lidocaine |
| D011318 | Prilocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
|
| Other |
|
| Not Available |
|
| Units |
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| Counts |
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| Participants |
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| Units |
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| Counts |
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| Participants |
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Adverse events that did not occur at the nasolabial folds |
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| OG002 | Non-NLF | Adverse events that did not occur at the nasolabial folds |
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