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This is a prospective, open-label, multicentre, randomized study conducted to evaluate the effectiveness, safety and long-term safety of Saypha® FILLER Lidocaine for lip augmentation.
Following informed consent and screening, eligible subjects with moderate to severe deficiency of lip volume will be randomized to receive Saypha® FILLER Lidocaine from 1 of 2 manufacturing sites. The device will be injected into the submucosa of the lips, and subjects will return for follow-up assessments at Week 3, 6, 26, 52 and optional at Week 76 after the treatment.
A Touch-up treatment may be done at Week 3, if deemed appropriate by the investigator. The performance of the investigational device will be evaluated by the investigator by assessing severity using the LFS, Lip Fullness Scale, at Week 6, 26, 52 after the treatment and optional at Week 76 and in comparison to Day 0. The upper and lower lip will be graded separately.
Telephone visits will be performed approximately 24 hours post-administration to monitor possible adverse events. In case any adverse events are reported during the telephone visits an unscheduled visit should be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saypha® FILLER HQ | Experimental | Eligible subjects will undergo bilateral lip augmentation treatments with Saypha® FILLER Lidocaine manufactured in the Croma Pharma HQ Facility in order to correct moderate to severe deficiency of lip volume. The treatment will be administered at the Baseline visit (Day 0). |
|
| Saypha® FILLER C1 | Active Comparator | Eligible subjects will undergo bilateral lip augmentation treatments with Saypha® FILLER Lidocaine manufactured in the Croma Pharma C1 Facility in order to correct moderate to severe deficiency of lip volume. The treatment will be administered at the Baseline visit (Day 0). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saypha® FILLER Lidocaine (HQ) | Combination Product | Saypha® FILLER Lidocaine is administered by injection into the lips. The volume applied depends on the size of the area which requires correction and will be selected by the investigator. A maximum volume of 2 mL for both lips in total (i.e., for upper plus lower lip) including touch up might be needed per treatment but the treatment should not exceed 10 mL in total per treatment or 20 mL per year. |
| Measure | Description | Time Frame |
|---|---|---|
| Responder Rate in Lip Volume Improvement | The proportion of subjects ('responders') with the lip volume improved by ≥1 point versus baseline value at 6 weeks after initial treatment based on the investigator live assessment using the validated Lip Fullness Scale (LFS). Lip Fullness Scale (LFS) is a validated 5-point rating scale,that evaluates the Lip Volume Deficiency ranging from Grade 1 (minimal volume) to Grade 5 (very significant volume): In this case, the bigger the number, the better. | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders Based on the Investigator Live Assessment | The percentage of responders (with the Lip Volume Improved by >=1 Point Versus Baseline Value,) based on the investigator live assessment at 6, 12 and optional 18 months after the initial treatment using the validated LFS. Lip Fullness Scale (LFS) is a validated 5-point rating scale,that evaluates the Lip Volume Deficiency ranging from Grade 1 (minimal volume) to Grade 5 (very significant volume): In this case, the bigger the number, the better. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinisch Aesthetisches Zentrum Wien | Vienna | 1010 | Austria | |||
| YUVELL - Home of Aesthetics |
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Screened patients: N=121; Screening failures: N=7; Patients enrolled = Patients Treated with IMD: N= 114
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| ID | Title | Description |
|---|---|---|
| FG000 | Saypha® FILLER HQ | Eligible subjects will undergo bilateral lip augmentation treatments with Saypha® FILLER Lidocaine manufactured in the Croma Pharma HQ Facility in order to correct moderate to severe deficiency of lip volume. The treatment will be administered at the Baseline visit (Day 0). Saypha® FILLER Lidocaine (HQ): Saypha® FILLER Lidocaine is administered by injection into the lips. The volume applied depends on the size of the area which requires correction and will be selected by the investigator. A maximum volume of 2 mL for both lips in total (i.e., for upper plus lower lip) including touch up might be needed per treatment but the treatment should not exceed 10 mL in total per treatment or 20 mL per year. |
| FG001 | Saypha® FILLER C1 | Eligible subjects will undergo bilateral lip augmentation treatments with Saypha® FILLER Lidocaine manufactured in the Croma Pharma C1 Facility in order to correct moderate to severe deficiency of lip volume. The treatment will be administered at the Baseline visit (Day 0). Saypha® FILLER Lidocaine (C1): Saypha® FILLER Lidocaine is administered by injection into the lips. The volume applied depends on the size of the area which requires correction and will be selected by the investigator. A maximum volume of 2 mL for both lips in total (i.e., for upper plus lower lip) including touch up might be needed per treatment but the treatment should not exceed 10 mL in total per treatment or 20 mL per year. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Population considered for this analysis is the Full Analysis Set (FAS) which comprises all subjects who received at least 1 administration of the IMD and who had at least 1 post-treatment evaluation of the LFS.
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| ID | Title | Description |
|---|---|---|
| BG000 | Saypha® FILLER HQ | Eligible subjects will undergo bilateral lip augmentation treatments with Saypha® FILLER Lidocaine manufactured in the Croma Pharma HQ Facility in order to correct moderate to severe deficiency of lip volume. The treatment will be administered at the Baseline visit (Day 0). Saypha® FILLER Lidocaine (HQ): Saypha® FILLER Lidocaine is administered by injection into the lips. The volume applied depends on the size of the area which requires correction and will be selected by the investigator. A maximum volume of 2 mL for both lips in total (i.e., for upper plus lower lip) including touch up might be needed per treatment but the treatment should not exceed 10 mL in total per treatment or 20 mL per year. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Responder Rate in Lip Volume Improvement | The proportion of subjects ('responders') with the lip volume improved by ≥1 point versus baseline value at 6 weeks after initial treatment based on the investigator live assessment using the validated Lip Fullness Scale (LFS). Lip Fullness Scale (LFS) is a validated 5-point rating scale,that evaluates the Lip Volume Deficiency ranging from Grade 1 (minimal volume) to Grade 5 (very significant volume): In this case, the bigger the number, the better. | Population considered for this analysis is the Full Analysis Set (FAS) which comprises all subjects who received at least 1 administration of the IMD and who had at least 1 post-treatment evaluation of the LFS. Individual LFS grades per visit are calculated separately for the upper and the lower lip. | Posted | Count of Participants | Participants | Week 6 |
|
Adverse events (AEs) were documented from the time of first IMD application at Baseline visit (Visit 1) throughout the course of the clinical investigation, which means up to 18 months after IMD application.
AEs will be detected at each visit by observation and by asking the subject about the occurrence of AEs. Care should be taken not to introduce bias when eliciting AE information from the subject. Open-ended and non-leading verbal questioning is the preferred method. In addition, the subjects will be instructed to immediately contact the investigator/investigation site in case of occurrence of any untoward event between visits and an unscheduled visit will be performed.
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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 | Saypha® FILLER HQ | Eligible subjects will undergo bilateral lip augmentation treatments with Saypha® FILLER Lidocaine manufactured in the Croma Pharma HQ Facility in order to correct moderate to severe deficiency of lip volume. The treatment will be administered at the Baseline visit (Day 0). Saypha® FILLER Lidocaine (HQ): Saypha® FILLER Lidocaine is administered by injection into the lips. The volume applied depends on the size of the area which requires correction and will be selected by the investigator. A maximum volume of 2 mL for both lips in total (i.e., for upper plus lower lip) including touch up might be needed per treatment but the treatment should not exceed 10 mL in total per treatment or 20 mL per year. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | Non-systematic Assessment | Worsening of Depression |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pain | General disorders | Non-systematic Assessment | This event is related with the context of an injection site reaction |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Operations | CROMA - PHARMA | +43 0226268468 | clinical.studies@croma.at |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 27, 2019 | Dec 11, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 7, 2021 | Dec 11, 2024 | SAP_001.pdf |
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|
| Saypha® FILLER Lidocaine (C1) | Combination Product | Saypha® FILLER Lidocaine is administered by injection into the lips. The volume applied depends on the size of the area which requires correction and will be selected by the investigator. A maximum volume of 2 mL for both lips in total (i.e., for upper plus lower lip) including touch up might be needed per treatment but the treatment should not exceed 10 mL in total per treatment or 20 mL per year. |
|
| 6, 12 and optional 18 months |
| Percentage of Responders Based on the Independent Photographic Reviewer´s Assessments | The percentage of responders based on the independent photographic reviewer´s assessments at Week 6, Month 6, 12 and optional Month 18 after initial treatment, based on photographs and using the validated LFS (compared to Baseline). Lip Fullness Scale (LFS) is a validated 5-point rating scale,that evaluates the Lip Volume Deficiency ranging from Grade 1 (minimal), Grade 2 (slight), Grade 3 (moderately thick), Grade 4 (thick), to Grade 5 (very significant): In this case, the bigger the number, the better. | Week 6, Month 6, 12 and optional Month 18 |
| Percentage of Subjects With an Improvement Based on the Investigator Assessment Using GAIS | The percentage of subjects with an improvement relative to baseline photographs, (subjects who have been rated as "very much improved" or "much improved" or "improved"), based on the investigator assessment at Week 6, Month 6, 12 and optional Month 18 after initial treatment using the 5-point GAIS. | Week 6, Month 6, 12 and optional Month 18 |
| Percentage of Subjects With an Improvement Based on Subject Assessment Using GAIS | The percentage of subjects with an improvement relative to baseline photographs (subjects who have been rated as "very much improved" or "much improved" or "improved"), based on subject assessment at Week 6, Month 6, 12 and optional Month 18 after initial treatment, using the 5-point GAIS with results ranging from 1 to 5 with lower numbers indicating better improvement | Week 6, Month 6, 12 and optional Month 18 |
| Subject Satisfaction Using Face-Q Questionnaire | The extent of subject´s satisfaction with overall outcome of the treatment, at Week 6, Month 6, 12 and optional Month 18 after initial treatment, assessed by the subject using the Face-Q TM Questionnaire. The FACE-Q Satisfaction with Outcome scale is a patient-reported outcome measure designed to assess a patient's satisfaction with the results of a facial aesthetic procedure. This scale comprises six items, each with four response options: "definitely agree," "somewhat agree," "somewhat disagree," and "definitely disagree." The raw summed scale score is converted to a score from 0 to 100 by using the respective Conversion Tables available from Face Q authors. Higher scores reflect a better outcome (i.e., 0 (worst) to 100 (best)). | Week 6, Month 6, 12 and optional Month 18 |
| Subject Satisfaction Using Face-Q TM Questionnaire "Satisfaction With Lips" | The extent of subject's satisfaction with augmentation of lips, at Week 6, Month 6, 12 and optional Month 18 after initial treatment, assessed by the subject using the Face-Q TM Questionnaire "Satisfaction with Lips", a 6-items Aesthetic Appearance Questionnaire with 5 pre-defined answer options between "very satisfied" and "very dissatisfied". The extent of subject´s satisfaction with overall outcome of the treatment, at Week 6, Month 6, 12 and optional Month 18 after initial treatment, assessed by the subject using the Face-Q. The raw summed scale score is converted to a score from 0 to 100 by using the respective Conversion Tables available from Face Q authors. Higher scores reflect a better outcome (i.e., 0 (worst) to 100 (best)). | Week 6, Month 6, 12 and optional Month 18 |
| Subject's Perception of Pain Using the 11-point Numeric Pain Rating Scale | Subject's perception of pain after initial and touch-up treatment with Saypha® FILLER Lidocaine using the 11-point Numeric Pain Rating Scale (NPRS), where 0 is no pain and 10 is the worst pain imaginable. | Day1, Week 3 |
| Percentage of Subjects Demonstrating an Aesthetic Effect | Percentage of subjects demonstrating an aesthetic effect at Week 6, Month 6, 12 and optional Month 18 based on the investigator's life assessment. A live assessment of the treated areas was performed and the treated areas compared to the subject's photographs obtained at the Baseline Visit. The presence of the aesthetic effect was recorded as either "Yes" or "No" | Week 6, Month 6, 12 and optional Month 18 |
| Injection Volume Required | Injection volume (initial and touch-up) required for an optimal augmentation of the lips with Saypha® FILLER Lidocaine. | Day1, Week 3 |
| Vienna |
| 1010 |
| Austria |
| PW-Privatklinik Waehring GmbH | Vienna | 1180 | Austria |
| BG001 | Saypha® FILLER C1 | Eligible subjects will undergo bilateral lip augmentation treatments with Saypha® FILLER Lidocaine manufactured in the Croma Pharma C1 Facility in order to correct moderate to severe deficiency of lip volume. The treatment will be administered at the Baseline visit (Day 0). Saypha® FILLER Lidocaine (C1): Saypha® FILLER Lidocaine is administered by injection into the lips. The volume applied depends on the size of the area which requires correction and will be selected by the investigator. A maximum volume of 2 mL for both lips in total (i.e., for upper plus lower lip) including touch up might be needed per treatment but the treatment should not exceed 10 mL in total per treatment or 20 mL per year. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Smoking habit | Smoking habit: Former smoker: greater than 3 months since smoking cessation; Current smoker: less than 3 months since smoking cessation | Count of Participants | Participants |
|
Eligible subjects will undergo bilateral lip augmentation treatments with Saypha® FILLER Lidocaine manufactured in the Croma Pharma HQ Facility in order to correct moderate to severe deficiency of lip volume.
The treatment will be administered at the Baseline visit (Day 0).
Saypha® FILLER Lidocaine (HQ): Saypha® FILLER Lidocaine is administered by injection into the lips. The volume applied depends on the size of the area which requires correction and will be selected by the investigator. A maximum volume of 2 mL for both lips in total (i.e., for upper plus lower lip) including touch up might be needed per treatment but the treatment should not exceed 10 mL in total per treatment or 20 mL per year.
| OG001 | Saypha® FILLER C1 | Eligible subjects will undergo bilateral lip augmentation treatments with Saypha® FILLER Lidocaine manufactured in the Croma Pharma C1 Facility in order to correct moderate to severe deficiency of lip volume. The treatment will be administered at the Baseline visit (Day 0). Saypha® FILLER Lidocaine (C1): Saypha® FILLER Lidocaine is administered by injection into the lips. The volume applied depends on the size of the area which requires correction and will be selected by the investigator. A maximum volume of 2 mL for both lips in total (i.e., for upper plus lower lip) including touch up might be needed per treatment but the treatment should not exceed 10 mL in total per treatment or 20 mL per year. |
| OG002 | Overall Population (Saypha® FILLER HQ + Saypha® FILLER C1) | Total eligible subjects that had bilateral lip augmentation treatments with both Saypha® FILLER Lidocaine manufactured in the Croma Pharma C1 Facility and with Saypha® FILLER Lidocaine manufactured in the Croma Pharma in HQ facility. |
|
|
| Secondary | Percentage of Responders Based on the Investigator Live Assessment | The percentage of responders (with the Lip Volume Improved by >=1 Point Versus Baseline Value,) based on the investigator live assessment at 6, 12 and optional 18 months after the initial treatment using the validated LFS. Lip Fullness Scale (LFS) is a validated 5-point rating scale,that evaluates the Lip Volume Deficiency ranging from Grade 1 (minimal volume) to Grade 5 (very significant volume): In this case, the bigger the number, the better. | FAS (defined in the Analyis Population description of the primary outcome measure) was considered for the analysis of the secondary endpoints. | Posted | Count of Participants | Participants | 6, 12 and optional 18 months |
|
|
|
| Secondary | Percentage of Responders Based on the Independent Photographic Reviewer´s Assessments | The percentage of responders based on the independent photographic reviewer´s assessments at Week 6, Month 6, 12 and optional Month 18 after initial treatment, based on photographs and using the validated LFS (compared to Baseline). Lip Fullness Scale (LFS) is a validated 5-point rating scale,that evaluates the Lip Volume Deficiency ranging from Grade 1 (minimal), Grade 2 (slight), Grade 3 (moderately thick), Grade 4 (thick), to Grade 5 (very significant): In this case, the bigger the number, the better. | FAS - see primary endopoint for FAS definition | Posted | Count of Participants | Participants | Week 6, Month 6, 12 and optional Month 18 |
|
|
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| Secondary | Percentage of Subjects With an Improvement Based on the Investigator Assessment Using GAIS | The percentage of subjects with an improvement relative to baseline photographs, (subjects who have been rated as "very much improved" or "much improved" or "improved"), based on the investigator assessment at Week 6, Month 6, 12 and optional Month 18 after initial treatment using the 5-point GAIS. | FAS - Please see primary endpoint for definition | Posted | Count of Participants | Participants | Week 6, Month 6, 12 and optional Month 18 |
|
|
|
| Secondary | Percentage of Subjects With an Improvement Based on Subject Assessment Using GAIS | The percentage of subjects with an improvement relative to baseline photographs (subjects who have been rated as "very much improved" or "much improved" or "improved"), based on subject assessment at Week 6, Month 6, 12 and optional Month 18 after initial treatment, using the 5-point GAIS with results ranging from 1 to 5 with lower numbers indicating better improvement | FAS - please see primary endpoint description | Posted | Count of Participants | Participants | Week 6, Month 6, 12 and optional Month 18 |
|
|
|
| Secondary | Subject Satisfaction Using Face-Q Questionnaire | The extent of subject´s satisfaction with overall outcome of the treatment, at Week 6, Month 6, 12 and optional Month 18 after initial treatment, assessed by the subject using the Face-Q TM Questionnaire. The FACE-Q Satisfaction with Outcome scale is a patient-reported outcome measure designed to assess a patient's satisfaction with the results of a facial aesthetic procedure. This scale comprises six items, each with four response options: "definitely agree," "somewhat agree," "somewhat disagree," and "definitely disagree." The raw summed scale score is converted to a score from 0 to 100 by using the respective Conversion Tables available from Face Q authors. Higher scores reflect a better outcome (i.e., 0 (worst) to 100 (best)). | The population considered for this analysis comprises all subjects who received at least 1 administration of the Investigational Medical Device, who had at least 1 post-treatment evaluation using the Lip Fullness Scale and who have Face-Q measurements available for the respective timepoints. In the protocol and statistical analysis plan, the analysis for this outcome measure was planned only for the overall population and not for the randomized subgroups Saypha® FILLER HQ and Saypha® FILLER C1. | Posted | Mean | Standard Deviation | score on Face Q questionnaire | Week 6, Month 6, 12 and optional Month 18 |
|
|
|
| Secondary | Subject Satisfaction Using Face-Q TM Questionnaire "Satisfaction With Lips" | The extent of subject's satisfaction with augmentation of lips, at Week 6, Month 6, 12 and optional Month 18 after initial treatment, assessed by the subject using the Face-Q TM Questionnaire "Satisfaction with Lips", a 6-items Aesthetic Appearance Questionnaire with 5 pre-defined answer options between "very satisfied" and "very dissatisfied". The extent of subject´s satisfaction with overall outcome of the treatment, at Week 6, Month 6, 12 and optional Month 18 after initial treatment, assessed by the subject using the Face-Q. The raw summed scale score is converted to a score from 0 to 100 by using the respective Conversion Tables available from Face Q authors. Higher scores reflect a better outcome (i.e., 0 (worst) to 100 (best)). | The population considered for this analysis comprises all subjects who received at least 1 administration of the Investigational Medical Device, who had at least 1 post-treatment evaluation using the Lip Fullness Scale and who have Face-Q measurements available for the respective timepoints. In the protocol and statistical analysis plan, the analysis for this outcome measure was planned only for the overall population and not for the randomized subgroups Saypha® FILLER HQ and Saypha® FILLER C1. | Posted | Mean | Standard Deviation | score Face Q questionnaire | Week 6, Month 6, 12 and optional Month 18 |
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|
|
| Secondary | Subject's Perception of Pain Using the 11-point Numeric Pain Rating Scale | Subject's perception of pain after initial and touch-up treatment with Saypha® FILLER Lidocaine using the 11-point Numeric Pain Rating Scale (NPRS), where 0 is no pain and 10 is the worst pain imaginable. | FAS-please see primary endpoint population definition | Posted | Mean | Standard Deviation | score on a scale | Day1, Week 3 |
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| Secondary | Percentage of Subjects Demonstrating an Aesthetic Effect | Percentage of subjects demonstrating an aesthetic effect at Week 6, Month 6, 12 and optional Month 18 based on the investigator's life assessment. A live assessment of the treated areas was performed and the treated areas compared to the subject's photographs obtained at the Baseline Visit. The presence of the aesthetic effect was recorded as either "Yes" or "No" | The population considered for this analysis comprises all subjects who received at least 1 administration of the Investigational Medical Device and who had at least 1 post-treatment evaluation using the Lip Fullness Scale. In the protocol and statistical analysis plan, the analysis for this outcome measure was planned only for the overall population and not for the randomized subgroups Saypha® FILLER HQ and Saypha® FILLER C1. | Posted | Count of Participants | Participants | Week 6, Month 6, 12 and optional Month 18 |
|
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| Secondary | Injection Volume Required | Injection volume (initial and touch-up) required for an optimal augmentation of the lips with Saypha® FILLER Lidocaine. | The population considered for this analysis comprises all subjects who had at least 1 post-treatment evaluation using the Lip Fullness Scale and who received treatment with the Investigational Medical Device at the respective timepoints. In the protocol and statistical analysis plan, the analysis for this outcome measure was planned only for the overall population and not for the randomized subgroups Saypha® FILLER HQ and Saypha® FILLER C1. | Posted | Mean | Standard Deviation | ml | Day1, Week 3 |
|
|
|
| 0 |
| 57 |
| 0 |
| 57 |
| 35 |
| 57 |
| EG001 | Saypha® FILLER C1 | Eligible subjects will undergo bilateral lip augmentation treatments with Saypha® FILLER Lidocaine manufactured in the Croma Pharma C1 Facility in order to correct moderate to severe deficiency of lip volume. The treatment will be administered at the Baseline visit (Day 0). Saypha® FILLER Lidocaine (C1): Saypha® FILLER Lidocaine is administered by injection into the lips. The volume applied depends on the size of the area which requires correction and will be selected by the investigator. A maximum volume of 2 mL for both lips in total (i.e., for upper plus lower lip) including touch up might be needed per treatment but the treatment should not exceed 10 mL in total per treatment or 20 mL per year. | 0 | 57 | 1 | 57 | 32 | 57 |
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| Injection Site Bruising | General disorders | Non-systematic Assessment | Injection site reaction |
|
| Injection site swelling | General disorders | Non-systematic Assessment | Injection site reaction |
|
| COVID 19 | Infections and infestations | Non-systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
| Month 12 Lower Lips |
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| Month 12 Upper Lips |
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| Month 18 Lower Lips |
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| Month 18 Upper Lips |
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| Title | Measurements |
|---|---|
|
| Month 6 - Lower Lip |
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| Month 6 - Upper Lip |
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| Month 12 - Lower Lip |
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| Month 12 - Upper Lip |
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| Month 18 - Lower Lip |
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| Month 18 - Upper Lip |
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| Title | Measurements |
|---|---|
|
| Month 6 - Lower Lip |
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| Month 6 - Upper Lip |
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| Month 12- Lower Lip |
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| Month 12 - Upper Lip |
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| Month 18 - Lower Lip |
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| Month 18 -Upper Lip |
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| Month 6 - Lower Lips |
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| Month 6 - Upper Lips |
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| Month 12 - Lower Lips |
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| Month 12 - Upper Lips |
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| Month 18 - Lower Lips |
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| Month 18 - Upper Lips |
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| Month 12 |
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| Month 18 |
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| Month 12 |
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| Month 18 |
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| Initial Treatment - 15 min post treatment |
|
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| Touch up (Week 3) - Immediately after treatment |
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| Touch up (Week 3 ) - 15 min post treatment |
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| Title | Measurements |
|---|
|
| Month 18 |
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| Day 1 - initial treatment - both lips |
|
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| Week 3 - touch up treatment - lower lip |
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| Week 3 - touch up treatment - upper lip |
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| Week 3 - touch up treatment - both lips |
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