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| Name | Class |
|---|---|
| FGK Clinical Research GmbH | INDUSTRY |
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The aim of this clinical trial is to evaluate the efficacy and safety of Princess® VOLUME for the correction of nasolabial folds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Princess® VOLUME | Experimental | Injection of Princess® VOLUME into the deep dermis or subcutis of both nasolabial folds. A touch-up treatment may be performed at Day 14 if correction is not complete after the first injection. The injected volumes will be estimated by the investigator and depend on the depth of the nasolabial folds |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Princess® VOLUME | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Modified Fitzpatrick Wrinkle Scale (MFWS) From Day 0 to Day 180 | The primary efficacy endpoint was the absolute change in MFWS from Day 0 to Day 180 The Modified Fitzpatrick Wrinkle Scale (MFWS), an established objective and validated measurement for nasolabial wrinkle severity assessments. The MFWS is a 7-point rating scale ranging from 0 = no wrinkle to 3 = deep wrinkle where grades are defined as follow: Grade Definition 0 No wrinkle: no visible wrinkle, continuous skin line 0.5 Very shallow yet visible wrinkle
| From Day 0 to Day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Modified Fitzpatrick Wrinkle Scale (MFWS) From Day 0 to Days 30, 90, and 270 | The change in absolute Modified Fitzpatrick Wrinkle Scale (MFWS) from Day 0 was additionally assessed at Days 30, 90, and 270 The Modified Fitzpatrick Wrinkle Scale (MFWS), an established objective and validated measurement for nasolabial wrinkle severity assessments The MFWS is a 7-point rating scale ranging from 0 = no wrinkle to 3 = deep wrinkle where grades are defined as follow: Grade Definition 0 No wrinkle: no visible wrinkle, continuous skin line 0.5 Very shallow yet visible wrinkle
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Percentage of subjects with an improvement of at least 0.5 on the Modified Fitzpatrick Wrinkle Scale (MFWS) at Days 14, 30, 90, 180, and 270 The Modified Fitzpatrick Wrinkle Scale (MFWS), an established objective and validated measurement for nasolabial wrinkle severity assessments The MFWS is a 7-point rating scale ranging from 0 = no wrinkle to 3 = deep wrinkle where grades are defined as follow: Grade Definition 0 No wrinkle: no visible wrinkle, continuous skin line 0.5 Very shallow yet visible wrinkle
|
Major Inclusion Criteria:
Major Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daisy Kopera, Prof. Dr. | Department of Dermatology and Gerontology, Medical University Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Graz | Graz | Austria | ||||
| Ordination 1 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Princess® VOLUME | Subjects received one injection of the investigational device to both nasolabial folds on Day 0. After the initial treatment, a touch-up treatment was permitted on Day 14, if full correction of the wrinkle had not been achieved with the baseline treatment. The volume of application depended on the depth of wrinkle to be corrected and was chosen by the investigator. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
1 Subject was lost to follow up after Day 14
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| ID | Title | Description |
|---|---|---|
| BG000 | Princess® VOLUME | Subjects received one injection of the investigational device to both nasolabial folds on Day 0. After the initial treatment, a touch-up treatment was permitted on Day 14, if full correction of the wrinkle had not been achieved with the baseline treatment. The volume of application depended on the depth of wrinkle to be corrected and was chosen by the investigator. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 in Modified Fitzpatrick Wrinkle Scale (MFWS) From Day 0 to Day 180 | The primary efficacy endpoint was the absolute change in MFWS from Day 0 to Day 180 The Modified Fitzpatrick Wrinkle Scale (MFWS), an established objective and validated measurement for nasolabial wrinkle severity assessments. The MFWS is a 7-point rating scale ranging from 0 = no wrinkle to 3 = deep wrinkle where grades are defined as follow: Grade Definition 0 No wrinkle: no visible wrinkle, continuous skin line 0.5 Very shallow yet visible wrinkle
| safety analysis set (SAF) - The SAF included all subjects who received the investigational device at least once. The mean of both measurements (right/left nasolabial fold) is used. | Posted | Mean | Standard Deviation | score on a scale | From Day 0 to Day 180 |
|
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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 | Princess® VOLUME | Subjects received one injection of the investigational device to both nasolabial folds on Day 0. After the initial treatment, a touch-up treatment was permitted on Day 14, if full correction of the wrinkle had not been achieved with the baseline treatment. The volume of application depended on the depth of wrinkle to be corrected and was chosen by the investigator. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Uterin Polyp | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Operations | Croma Pharma | +43 2262 68468 | clinical.studies@croma.at |
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| Day 0 to Days 30, 90, and 270 |
| Percentage of Subjects With an Improvement of at Least 0.5 on the Modified Fitzpatrick Wrinkle Scale (MFWS) | Percentage of subjects with an improvement of at least 0.5 on the Modified Fitzpatrick Wrinkle Scale (MFWS) at Days 30, 90, 180, and 270 The Modified Fitzpatrick Wrinkle Scale (MFWS), an established objective and validated measurement for nasolabial wrinkle severity assessments The MFWS is a 7-point rating scale ranging from 0 = no wrinkle to 3 = deep wrinkle where grades are defined as follow: Grade Definition 0 No wrinkle: no visible wrinkle, continuous skin line 0.5 Very shallow yet visible wrinkle
| Days 30, 90, 180, and 270 |
| Subject Satisfaction | Subject satisfaction at Days 30, 90, 180, and 270 To assess subject's satisfaction, subjects were asked to indicate their level of satisfaction on 3- or 5-point scales as follows:
| Days 30, 90, 180, and 270 |
| Global Aesthetic Improvement Scale (GAIS) | Investigator rating of aesthetic improvement based on GAIS The GAIS is a 5-point scale that rates global aesthetic improvement in appearance, compared to pre-treatment, as judged by the investigator. The rating categories were 'worse', 'no change', 'improved', 'much improved', and 'very much improved'. | Days 14, 30, 90, 180, 270 |
| Day 0 to Day 14, 30, 90, 180, and 270 |
| Improvement in MFWS in One or Both Nasolabial Folds Over Time | Percentage of subjects with an improvement of at least 0.5 on the Modified Fitzpatrick Wrinkle Scale (MFWS) from Day 0 to Days 30, 90, 180, and 270 The Modified Fitzpatrick Wrinkle Scale (MFWS), an established objective and validated measurement for nasolabial wrinkle severity assessments. The MFWS is a 7-point rating scale ranging from 0 = no wrinkle to 3 = deep wrinkle where grades are defined as follow: Grade Definition 0 No wrinkle: no visible wrinkle, continuous skin line 0.5 Very shallow yet visible wrinkle
| Day 0 to Day 30, 90, 180, and 270 |
| Vienna |
| Austria |
| Ordination 2 | Vienna | Austria |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG000 | Princess® VOLUME | Subjects received one injection of the investigational device to both nasolabial folds on Day 0. After the initial treatment, a touch-up treatment was permitted on Day 14, if full correction of the wrinkle had not been achieved with the baseline treatment. The volume of application depended on the depth of wrinkle to be corrected and was chosen by the investigator. |
|
|
| Secondary | Change in the Modified Fitzpatrick Wrinkle Scale (MFWS) From Day 0 to Days 30, 90, and 270 | The change in absolute Modified Fitzpatrick Wrinkle Scale (MFWS) from Day 0 was additionally assessed at Days 30, 90, and 270 The Modified Fitzpatrick Wrinkle Scale (MFWS), an established objective and validated measurement for nasolabial wrinkle severity assessments The MFWS is a 7-point rating scale ranging from 0 = no wrinkle to 3 = deep wrinkle where grades are defined as follow: Grade Definition 0 No wrinkle: no visible wrinkle, continuous skin line 0.5 Very shallow yet visible wrinkle
| safety analysis set (SAF) - The SAF included all subjects who received the investigational device at least once. The mean of both measurements (right/left nasolabial fold) is used. | Posted | Mean | Standard Deviation | score on a scale | Day 0 to Days 30, 90, and 270 |
|
|
|
| Secondary | Percentage of Subjects With an Improvement of at Least 0.5 on the Modified Fitzpatrick Wrinkle Scale (MFWS) | Percentage of subjects with an improvement of at least 0.5 on the Modified Fitzpatrick Wrinkle Scale (MFWS) at Days 30, 90, 180, and 270 The Modified Fitzpatrick Wrinkle Scale (MFWS), an established objective and validated measurement for nasolabial wrinkle severity assessments The MFWS is a 7-point rating scale ranging from 0 = no wrinkle to 3 = deep wrinkle where grades are defined as follow: Grade Definition 0 No wrinkle: no visible wrinkle, continuous skin line 0.5 Very shallow yet visible wrinkle
| safety analysis set (SAF) - The SAF included all subjects who received the investigational device at least once. The mean of both measurements (right/left nasolabial fold) is used. | Posted | Count of Participants | Participants | Days 30, 90, 180, and 270 |
|
|
|
| Secondary | Subject Satisfaction | Subject satisfaction at Days 30, 90, 180, and 270 To assess subject's satisfaction, subjects were asked to indicate their level of satisfaction on 3- or 5-point scales as follows:
| safety analysis set (SAF) - The SAF included all subjects who received the investigational device at least once. The mean of both measurements (right/left nasolabial fold) is used. | Posted | Count of Participants | Participants | Days 30, 90, 180, and 270 |
|
|
|
| Secondary | Global Aesthetic Improvement Scale (GAIS) | Investigator rating of aesthetic improvement based on GAIS The GAIS is a 5-point scale that rates global aesthetic improvement in appearance, compared to pre-treatment, as judged by the investigator. The rating categories were 'worse', 'no change', 'improved', 'much improved', and 'very much improved'. | safety analysis set (SAF) - The SAF included all subjects who received the investigational device at least once.The mean of both measurements (right/left nasolabial fold) is used. | Posted | Count of Participants | Participants | Days 14, 30, 90, 180, 270 |
|
|
|
| Other Pre-specified | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Percentage of subjects with an improvement of at least 0.5 on the Modified Fitzpatrick Wrinkle Scale (MFWS) at Days 14, 30, 90, 180, and 270 The Modified Fitzpatrick Wrinkle Scale (MFWS), an established objective and validated measurement for nasolabial wrinkle severity assessments The MFWS is a 7-point rating scale ranging from 0 = no wrinkle to 3 = deep wrinkle where grades are defined as follow: Grade Definition 0 No wrinkle: no visible wrinkle, continuous skin line 0.5 Very shallow yet visible wrinkle
| Safety Analysis Set | Posted | Count of Participants | Participants | Day 0 to Day 14, 30, 90, 180, and 270 |
|
|
|
| Other Pre-specified | Improvement in MFWS in One or Both Nasolabial Folds Over Time | Percentage of subjects with an improvement of at least 0.5 on the Modified Fitzpatrick Wrinkle Scale (MFWS) from Day 0 to Days 30, 90, 180, and 270 The Modified Fitzpatrick Wrinkle Scale (MFWS), an established objective and validated measurement for nasolabial wrinkle severity assessments. The MFWS is a 7-point rating scale ranging from 0 = no wrinkle to 3 = deep wrinkle where grades are defined as follow: Grade Definition 0 No wrinkle: no visible wrinkle, continuous skin line 0.5 Very shallow yet visible wrinkle
| safety analysis set (SAF) - The SAF included all subjects who received the investigational device at least once.The mean of both measurements (right/left nasolabial fold) is used. | Posted | Count of Participants | Participants | Day 0 to Day 30, 90, 180, and 270 |
|
|
|
| 1 |
| 48 |
| 12 |
| 48 |
| bruising | General disorders | Non-systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
|
| Improvement of at least 0.5 Scores on the MFWS - day 270 |
|
|
| Day 30 : Q1 - Appearance after treatment - sligthly improved |
|
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| Day 30 : Q1 - Appearance after treatment - no change |
|
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| Day 30 : Q1 - Appearance after treatment - worsened |
|
|
| Day 30 : Q2 - Satisfaction with treatment - very satisfied |
|
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| Day 30 : Q2 - Satisfaction with treatment - satisfied |
|
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| Day 30 : Q2 - Satisfaction with treatment - not satisfied |
|
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| Day 30 : Q3 - Recommendation of treatment - yes |
|
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| Day 30 : Q3 - Recommendation of treatment - perhaps |
|
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| Day 30 : Q3 - Recommendation of treatment - no |
|
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| Day 90 : Q1 - Appearance after treatment - very much improved |
|
|
| Day 90 : Q1 - Appearance after treatment - much improved |
|
|
| Day 90 : Q1 - Appearance after treatment - sligthly improved |
|
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| Day 90 : Q1 - Appearance after treatment - no change |
|
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| Day 90 : Q1 - Appearance after treatment - worsened |
|
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| Day 90 : Q2 - Satisfaction with treatment - very satisfied |
|
| Day 90 : Q2 - Satisfaction with treatment - satisfied |
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| Day 90 : Q2 - Satisfaction with treatment - not satisfied |
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| Day 90 : Q3 - Recommendation of treatment - yes |
|
| Day 90 : Q3 - Recommendation of treatment - perhaps |
|
| Day 90 : Q3 - Recommendation of treatment - no |
|
| Day 180 : Q1 - Appearance after treatment - very much improved |
|
|
| Day 180 : Q1 - Appearance after treatment - much improved |
|
|
| Day 180 : Q1 - Appearance after treatment - sligthly improved |
|
|
| Day 180 : Q1 - Appearance after treatment - no change |
|
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| Day 180 : Q1 - Appearance after treatment - worsened |
|
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| Day 180 : Q2 - Satisfaction with treatment - very satisfied |
|
| Day 180 : Q2 - Satisfaction with treatment - satisfied |
|
| Day 180 : Q2 - Satisfaction with treatment - not satisfied |
|
| Day 180 : Q3 - Recommendation of treatment - yes |
|
| Day 180 : Q3 - Recommendation of treatment - perhaps |
|
| Day 180 : Q3 - Recommendation of treatment - no |
|
| Day 270 : Q1 - Appearance after treatment - very much improved |
|
|
| Day 270 : Q1 - Appearance after treatment - much improved |
|
|
| Day 270 : Q1 - Appearance after treatment - sligthly improved |
|
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| Day 270 : Q1 - Appearance after treatment - no change |
|
|
| Day 270 : Q1 - Appearance after treatment - worsened |
|
|
| Day 270 : Q2 - Satisfaction with treatment - very satisfied |
|
|
| Day 270 : Q2 - Satisfaction with treatment - satisfied |
|
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| Day 270 : Q2 - Satisfaction with treatment - not satisfied |
|
|
| Day 270 : Q3 - Recommendation of treatment - yes |
|
|
| Day 270 : Q3 - Recommendation of treatment - perhaps |
|
|
| Day 270 : Q3 - Recommendation of treatment - no |
|
|
| improved |
|
| no change |
|
| worse |
|
| Day 14 - left NLF |
|
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| Day 30 - right NLF |
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| Day 30 - left NLF |
|
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| Day 90 - right NLF |
|
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| Day 90 - left NLF |
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| Day 180 - right NLF |
|
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| Day 180 - left NLF |
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| Day 270 - right NLF |
|
|
| Day 270 - left NLF |
|
|
| Grade 1 |
|
| Grade 1.5 |
|
| Grade 2 |
|
| Grade 2.5 |
|
| Grade 3 |
|
| Day 0 - left NLF |
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| Day 14 - right NLF |
|
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| Day 14 - left NLF |
|
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| Day 30 - right NLF |
|
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| Day 30 - left NLF |
|
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| Day 90 - right NLF |
|
|
| Day 90 - left NLF |
|
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| Day 180 - right NLF |
|
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| Day 180 - left NLF |
|
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| Day 270 - right NLF |
|
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| Day 270 - left NLF |
|
|
| Title | Measurements |
|---|---|
|
| Day 30 : 1.5 one NLF |
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| Day 30 : 1.5 both NLFs |
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| Day 30 : 2.0 one NLF |
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| Day 30 : 2.0 both NLFs |
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| Day 90 : 0.5 both NLFs |
|
| Day 90 : 1.0 one NLF |
|
| Day 90 : 1.0 both NLFs |
|
| Day 90 : 1.5 one NLF |
|
| Day 90 : 1.5 both NLFs |
|
| Day 90 : 2.0 one NLF |
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| Day 90 : 2.0 both NLFs |
|
| Day 180 : 0.5 both NLFs |
|
| Day 180 : 1.0 one NLF |
|
| Day 180 : 1.0 both NLFs |
|
| Day 180 : 1.5 one NLF |
|
| Day 180 : 1.5 both NLFs |
|
| Day 180 : 2.0 one NLF |
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| Day 180 : 2.0 both NLFs |
|
| Day 270 : 0.5 both NLFs |
|
| Day 270 : 1.0 one NLF |
|
| Day 270 : 1.0 both NLFs |
|
| Day 270 : 1.5 one NLF |
|
| Day 270 : 1.5 both NLFs |
|
| Day 270 : 2.0 one NLF |
|
| Day 270 : 2.0 both NLFs |
|