Nasolabial Fold, Safety
Conditions
Keywords
Hyaluronic Acid, Lidocaine
Brief summary
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.
Interventions
DEVICEGP0045
Hyaluronic acid gel
DEVICEComparator
Hyaluronic acid gel
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Ability to adequately understand the verbal explanations and the written subject information provided in local language and ability to give consent to participate in the study * Signed and dated informed consent to participate in the study, including photo consent * Subjects with intent to undergo correction of both nasolabial folds
Exclusion criteria
* Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel * Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics * Any condition (medical or other) that, in the opinion of the Investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study) * Participation in any other clinical study with an investigational product within 30 days before treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale | 2 weeks, 3, 9, 12, 15 and 18 months | 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. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| 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 | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | GP0045 in Right NLF and Comparator in Left NLF | Comparator in Right NLF and GP0045 in Left NLF | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 8 Participants | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 10 Participants | 20 Participants |
| Region of Enrollment Sweden | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 8 / 10 | 10 / 10 |
| serious Total, serious adverse events | 1 / 10 | 0 / 10 |
Outcome results
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.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP0045 | Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale | 63.2 percentage of participants |
| Comparator | Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale | 68.4 percentage of 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.
Time frame: 2 weeks, 3, 9, 12, 15 and 18 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GP0045 | Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale | 2 weeks | 100 percentage of participants |
| GP0045 | Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale | 3 months | 89.5 percentage of participants |
| GP0045 | Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale | 9 months | 36.8 percentage of participants |
| GP0045 | Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale | 12 months | 15.8 percentage of participants |
| GP0045 | Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale | 15 months | 10.5 percentage of participants |
| GP0045 | Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale | 18 months | 0 percentage of participants |
| Comparator | Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale | 15 months | 5.3 percentage of participants |
| Comparator | Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale | 2 weeks | 100 percentage of participants |
| Comparator | Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale | 12 months | 21.1 percentage of participants |
| Comparator | Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale | 3 months | 89.5 percentage of participants |
| Comparator | Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale | 18 months | 0 percentage of participants |
| Comparator | Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale | 9 months | 26.3 percentage of participants |