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This is a study to assess the performance and safety of GP0045 when injected in the nasolabial folds.
There is an 18 months follow up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GP0045 | Experimental | Treatment with GP0045 |
|
| Comparator | Active Comparator | Treatment with active comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GP0045 | Device | Hyaluronic acid gel |
| |
| Comparator |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale | The scale is a 5-graded NLF wrinkle severity scale ranging from absent (Grade 1) to severe (Grade 5). The response rate was defined as the percentage of subjects with at least 1 grade improvement in NLF wrinkle severity. Assessment made by blinded evaluator. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale | The scale is a 5-graded NLF wrinkle severity scale ranging from absent (Grade 1) to severe (Grade 5). The response rate was defined as the percentage of subjects with at least 1 grade improvement in NLF wrinkle severity. Assessment made by blinded evaluator. | 2 weeks, 3, 9, 12, 15 and 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Q-Med AB | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Q-Med | Uppsala | Sweden |
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| ID | Title | Description |
|---|---|---|
| FG000 | GP0045 in Right NLF and Comparator in Left NLF | Treatment with GP0045 in right NLF (nasolabial fold) and comparator in left NLF GP0045: Hyaluronic acid gel Comparator: Hyaluronic acid gel |
| FG001 | Comparator in Right NLF and GP0045 in Left NLF | Treatment with comparator in right NLF and GP0045 in left NLF GP0045: Hyaluronic acid gel Comparator: Hyaluronic acid gel |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GP0045 in Right NLF and Comparator in Left NLF | Treatment with GP0045 in right NLF and comparator in left NLF GP0045: Hyaluronic acid gel Comparator: Hyaluronic acid gel |
| BG001 | Comparator in Right NLF and GP0045 in Left NLF |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale | The scale is a 5-graded NLF wrinkle severity scale ranging from absent (Grade 1) to severe (Grade 5). The response rate was defined as the percentage of subjects with at least 1 grade improvement in NLF wrinkle severity. Assessment made by blinded evaluator. | Posted | Number | percentage of participants | 6 months |
|
18-19 months (depending on how long screening), from screening visit to final study visit.
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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 | GP0045 in Right NLF and Comparator in Left NLF | Treatment with GP0045 in right NLF (nasolabial fold) and comparator in left NLF |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment | Unrelated to study product/study product injection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oral disorder | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment | Related to study product or injection procedure. One event in right NLF (treated with comparator) and one event in left NLF (treated with GP0045). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Q-Med AB | +46184749000 | reception.seupp@galderma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 24, 2018 | Feb 11, 2020 | Prot_SAP_000.pdf |
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| Device |
Hyaluronic acid gel |
|
Treatment with comparator in right NLF and GP0045 in left NLF
GP0045: Hyaluronic acid gel Comparator: Hyaluronic acid gel
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale | The scale is a 5-graded NLF wrinkle severity scale ranging from absent (Grade 1) to severe (Grade 5). The response rate was defined as the percentage of subjects with at least 1 grade improvement in NLF wrinkle severity. Assessment made by blinded evaluator. | Posted | Number | percentage of participants | 2 weeks, 3, 9, 12, 15 and 18 months |
|
|
|
| 0 |
| 10 |
| 1 |
| 10 |
| 8 |
| 10 |
| EG001 | Comparator in Right NLF and GP0045 in Left NLF | Treatment with comparator in right NLF and GP0045 in left NLF | 0 | 10 | 0 | 10 | 10 | 10 |
|
|
| Implant site erythema | General disorders | MedDRA (20.0) | Systematic Assessment | Related to study product or injection procedure. One event in right NLF (treated with comparator) and one event in left NLF (treated with GP0045). |
|
| Implant site hypoesthesia | General disorders | MedDRA (20.0) | Systematic Assessment | Related to study product or injection procedure. In left NLF (treated with GP0045). |
|
| Implant site mass | General disorders | MedDRA (20.0) | Systematic Assessment | Related to study product or injection procedure. Both events in the NLF treated with GP0045. |
|
| Implant site pain | General disorders | MedDRA (20.0) | Systematic Assessment | Related to study product/injection. 9 events (5 participants) in the NLF treated with GP0045, 8 events (4 participants) in the NLF treated with comparator. (1 participant can report one event in left NLF and one event in right NLF at the same time.) |
|
| Implant site papules | General disorders | MedDRA (20.0) | Systematic Assessment | Related to study product or injection procedure. In the NLF treated with GP0045. |
|
| Implant site pruritus | General disorders | MedDRA (20.0) | Systematic Assessment | Related to study product or injection procedure. One event in the NLF treated with GP0045 and one event in the NLF treated with comparator. |
|
| Implant site swelling | General disorders | MedDRA (20.0) | Systematic Assessment | Related to study product/injection. 9 events (3 participants) in NLF treated with GP0045, 2 events (2 participants) in the NLF treated with comparator. (1 participant can report 1 event in the right NLF and 1 event in the left NLF at the same time). |
|
| Bradycardia | Cardiac disorders | MedDRA (20.0) | Systematic Assessment | Unrelated to study product/study product injection |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (20.0) | Systematic Assessment | Unrelated to study product/study product injection |
|
| Eye allergy | Eye disorders | MedDRA (20.0) | Systematic Assessment | Unrelated to study product/study product injection |
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| Iritis | Eye disorders | MedDRA (20.0) | Systematic Assessment | Unrelated to study product/study product injection |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment | Unrelated to study product/study product injection |
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| Gingival recession | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment | Unrelated to study product/study product injection |
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| Toothache | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment | Unrelated to study product/study product injection |
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| Nodule | General disorders | MedDRA (20.0) | Systematic Assessment | Unrelated to study product/study product injection |
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| Cholangitis | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment | Unrelated to study product/study product injection |
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| Gastroenteritis | Infections and infestations | MedDRA (20.0) | Systematic Assessment | Unrelated to study product/study product injection |
|
| Herpes zoster | Infections and infestations | MedDRA (20.0) | Systematic Assessment | Unrelated to study product/study product injection |
|
| Influenza | Infections and infestations | MedDRA (20.0) | Systematic Assessment | Unrelated to study product/study product injection |
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| Nasopharyngitis | Infections and infestations | MedDRA (20.0) | Systematic Assessment | Unrelated to study product/study product injection |
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| Oral herpes | Infections and infestations | MedDRA (20.0) | Systematic Assessment | Unrelated to study product/study product injection |
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| Pneumonia | Infections and infestations | MedDRA (20.0) | Systematic Assessment | Unrelated to study product/study product injection |
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| Tooth infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment | Unrelated to study product/study product injection |
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| Urinary tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment | Unrelated to study product/study product injection |
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| Arthropod sting | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment | Unrelated to study product/study product injection |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment | Unrelated to study product/study product injection |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment | Unrelated to study product/study product injection |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment | Unrelated to study product/study product injection |
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| Hyperlipidemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment | Unrelated to study product/study product injection |
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| Overweight | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment | Unrelated to study product/study product injection |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment | Unrelated to study product/study product injection |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment | Unrelated to study product/study product injection |
|
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment | Unrelated to study product/study product injection |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment | Unrelated to study product/study product injection |
|
| Headache | Nervous system disorders | MedDRA (20.0) | Systematic Assessment | Unrelated to study product/study product injection |
|
| Hematoma | Vascular disorders | MedDRA (20.0) | Systematic Assessment | Unrelated to study product/study product injection |
|
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| 9 months |
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| 12 months |
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| 15 months |
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| 18 months |
|