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| Name | Class |
|---|---|
| Syneos Health | OTHER |
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Clinical Investigation to demonstrate the effectiveness and safety of Princess Filler Lidocaine in the correction of moderate to severe nasolabial folds
Clinical Investigation to assess the effectiveness of "Princess Filler Lidocaine" in reducing the severity of nasolabial folds compared to "Juvederm Ultra XC", based on the independent blinded evaluating investigator live assessment using the Nasolabial Folds Severity Rating Scale (NLF-SRS) at Week 24 after initial treatment and relative to Baseline assessments
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment of device 1 on left side | Other | Treatment of nasolabial folds (NLF) with both Investigational Device and Comparator; Princess Filler Lidocaine is assigned to left NLF, Comparator is assigned to right NLF |
|
| Treatment of device 1 on right side | Other | Treatment of nasolabial folds (NLF) with both Investigational Device and Comparator; Princess Filler Lidocaine is assigned to right NLF, Comparator is assigned to left NLF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Princess Filler Lidocaine | Device | correction of nasolabial folds |
|
| Measure | Description | Time Frame |
|---|---|---|
| Responder Status Based on Independent Evaluating Investigator Live Assessment at Week 24 - Full Analysis Dataset | The percentage of responders based on the independent blinded evaluating investigator live assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This primary outcome measure is assessed first in a hierarchical testing sequence. | Week 24 |
| Responder Status Based on Independent Evaluating Investigator Live Assessment at Week 24 - Per Protocol Dataset | The percentage of responders based on the independent blinded evaluating investigator live assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This is the second outcome measure in the hierarchical testing sequence. Statistical significance for this measure will only be assessed if the first outcome measure achieves statistical significance at the predefined alpha level (0.025). | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Responder Status Based on Independent Photographic Reviewers Assessment at Week 24 - Full Analysis Dataset | The percentage of responders based on the independent photographic reviewers assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC and based on photographs. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This is the third outcome measure to be analyzed in the hierarchical testing sequence. Statistical significance for this measure will only be assessed if the first and second outcome measures achieve statistical significance at the predefined alpha level (0.025). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Snellen visual acuity test worse than 20/40 (with corrective eyewear, if applicable), abnormal confrontational visual field test, or abnormal ocular motility test.
Repeat Treatment - Inclusion Criteria:
Repeat Treatment - Exclusion Criteria:
Occurrence of an SAE or adverse event of special interest (AESI; i.e., changes in vision [loss of vision, blurriness, double vision, pain in or around the eye, blindness, blind spots, problems moving the eyes, change in peripheral vision], skin changing color around the eyelids or around the site of injection) during or after the initial injection and/or touch-up injection
Subjects who experienced visual changes or other serious medical conditions during or after the initial/touch-up injection
Subjects who have one of the following assessments during the visual examinations:
Subjects who became pregnant since start of the study or are planning to become pregnant during the clinical investigation
Known human immune deficiency virus-positive individuals
Presence of infectious, inflammatory or proliferative cancerous or pre-cancerous lesions in the area to be treated
Development of recurrent herpes simplex in the treatment area since study start
Development of any autoimmune or connective tissue disease since start of participation in the study, or current treatment with immunomodulating therapy
Development of uncontrolled (or instable) diabetes mellitus or any other systemic disease since study start
Development of a bleeding disorder since study start or use of anticoagulant, antiplatelet or thrombolytic medication from ten days pre- to three days post injection
Planned dental/oral surgery or modification (bridge-work, implants) within 2 weeks prior to injection and to a minimum of four weeks post injection
Any medical condition prohibiting the inclusion for repeat treatment according to the judgement of the treating investigator
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| Name | Affiliation | Role |
|---|---|---|
| David Bank, MD | Center of Dermatology, Cosmetic and Laser Surgery | Principal Investigator |
| Joel Cohen, MD | AboutSkin research, LLC | Principal Investigator |
| John Joseph, MDE | Dr. John Joseph Facial Plastic and Reconstructive Surgery | Principal Investigator |
| Gary Monheit, MD | Total Skin and Beauty Dermatology Center | Principal Investigator |
| Ava Shamban, MD | Ava MD | Principal Investigator |
| Susan Taylor, MD | University of Pennsylvania | Principal Investigator |
| Robert Weiss, MD | Maryland Laser Skin and Vein | Principal Investigator |
| Sabrina Fabi, MD | Cosmetic, Lazer, Dermatology | Principal Investigator |
| Jeanine Downie, MD | Image Dermatology P.C. | Principal Investigator |
| Jeremy Green, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gary Monheit | Birmingham | Alabama | 35205 | United States | ||
| John Joseph |
Not provided
Not provided
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Of 295 enrolled participants, 270 met inclusion criteria and were randomized to treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment With Princess Filler Lidocaine on Left Side, Treatment With Comparator on Right Side | Treatment of nasolabial folds (NLF) with both Investigational Device and Comparator. Princess Filler Lidocaine: Injection into the nasolabial fold on the left side of the face. Comparator: Injection into the nasolabial fold on the right side of the face. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Blinded Treatment Phase |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 15, 2021 | Dec 12, 2024 |
Not provided
Not provided
Pivotal study
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subject- and evaluator-blinded
| Week 24 |
| Responder Status Based on Independent Photographic Reviewers Assessment at Week 24 - Per Protocol Dataset | The percentage of responders based on the independent photographic reviewers assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC and based on photographs. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This is the fourth outcome measure in the hierarchical testing sequence. Testing for this measure is contingent upon statistical significance being demonstrated for the first three outcome measures at the predefined alpha level (0.025). | Week 24 |
| Responder Status Based on Treating Investigator Live Assessment at Week 24 - Full Analysis Set | The percentage of responders based on the treating investigator live assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This is the fifth outcome measure to be analyzed as part of the hierarchical testing sequence. Statistical significance will be assessed only if the first four outcome measures demonstrate statistical significance at the predefined alpha level (0.025). | Week 24 |
| Responder Status Based on Treating Investigator Live Assessment at Week 24 - Per Protocol Set | The percentage of responders based on the treating investigator live assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This is the sixth outcome measure to be analyzed as part of the hierarchical testing sequence. Statistical significance will be assessed only if the first five outcome measures demonstrate statistical significance at the predefined alpha level (0.025). | Week 24 |
| Improvement Over Baseline Based on Independent Blinded Evaluating Investigator Assessment at Week 24 | The percentage of subjects with an improvement over Baseline (subjects who have been rated as "very much improved" or "much improved" or "improved"), based on the independent blinded evaluating investigator assessment at Week 24 after initial treatment and using the 5-point Global Aesthetic Improvement Scale (GAIS). GAIS grades are ranked as "very much improved", "much improved", "improved", "no change", and "worse". | Week 24 |
| Improvement Over Baseline Based on Subject Assessment at Week 24 | The percentage of subjects with an improvement over Baseline (subjects who have been rated as "very much improved" or "much improved" or "improved"), based on subject assessment at Week 24 after initial treatment and using the 5-point Global Aesthetic Improvement Scale (GAIS). GAIS grades are ranked as "very much improved", "much improved", "improved", "no change", and "worse". | Week 24 |
| Skin Research Institute |
| Principal Investigator |
| Michael Gold, MD | Tennesse Clinical Research Institute | Principal Investigator |
| Beverly Hills |
| California |
| 91436 |
| United States |
| Sabrina Fabi | San Diego | California | 92121 | United States |
| Ava Shamban | Santa Monica | California | 90404 | United States |
| Joel Cohen | Greenwood Village | Colorado | 80111 | United States |
| Jeremy Green | Coral Gables | Florida | 33146 | United States |
| Robert Weiss | Hunt Valley | Maryland | 21030 | United States |
| Jeanine Downie | Montclair | New Jersey | 07042 | United States |
| The Center for Dermatology Cosmetic and Laser Surgery | New York | New York | 10549 | United States |
| Susan Taylor | Philadelphia | Pennsylvania | 19104 | United States |
| Michael Gold | Nashville | Tennessee | 37215 | United States |
| FG001 |
| Treatment With Princess Filler Lidocaine on Right Side, Treatment With Comparator on Left Side |
Treatment of nasolabial folds (NLF) with both Investigational Device and Comparator. Princess Filler Lidocaine: Injection into the nasolabial fold on the right side of the face. Comparator: Injection into the nasolabial fold on the left side of the face. |
| FG002 | Princess Filler Lidocaine Open Label Extension | Princess Filler Lidocaine Open Label Extension where all subjects from Arm 1 and 2 can receive Experimental Treatment to both right and left nasolabial folds. Princess Filler Lidocaine: Injection into nasolabial folds on both sides of the face. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Open Label Extension Phase |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment With Princess Filler Lidocaine on Left Side, Treatment With Comparator on Right Side | Treatment of nasolabial folds (NLF) with both Investigational Device and Comparator. Princess Filler Lidocaine: Injection into the nasolabial fold on the left side of the face. Comparator: Injection into the nasolabial fold on the right side of the face. |
| BG001 | Treatment With Princess Filler Lidocaine on Right Side, Treatment With Comparator on Left Side | Treatment of nasolabial folds (NLF) with both Investigational Device and Comparator. Princess Filler Lidocaine: Injection into the nasolabial fold on the right side of the face. Comparator: Injection into the nasolabial fold on the left side of the face. |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Fitzpatrick Skin Type | The Fitzpatrick skin type is a scale that classifies skin based on its reaction to sun exposure, specifically its tendency to burn or tan. It includes six types: Type I: very pale white skin, burns without tanning; Type II: white skin, burns and does not tan easily; Type III: fair skin, burns first then tans; Type IV: light brown skin, burns a little and tans easily; Type V: brown skin, easily tans to a darker color and rarely burns; Type VI: dark brown or black skin, never burns but tans darker | Count of Participants | Participants |
| |||||||||||||||||
| Nasolabial Folds-Severity Rating Scale (NLF-SRS) | Count of Participants | 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 | Responder Status Based on Independent Evaluating Investigator Live Assessment at Week 24 - Full Analysis Dataset | The percentage of responders based on the independent blinded evaluating investigator live assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This primary outcome measure is assessed first in a hierarchical testing sequence. | The population used consists of all randomized subjects who received Princess® FILLER Lidocaine AND the control Juvéderm® Ultra XC at the same visit as initial treatment; if subjects had received only one treatment (only Princess® FILLER Lidocaine or only Juvéderm® Ultra XC) during initial treatment they would have been excluded from the analysis set. Participants were analyzed as randomized. | Posted | Count of Participants | Participants | Week 24 |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Responder Status Based on Independent Evaluating Investigator Live Assessment at Week 24 - Per Protocol Dataset | The percentage of responders based on the independent blinded evaluating investigator live assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This is the second outcome measure in the hierarchical testing sequence. Statistical significance for this measure will only be assessed if the first outcome measure achieves statistical significance at the predefined alpha level (0.025). | The population used consists of all randomized subjects who received Princess® FILLER Lidocaine AND the control Juvéderm® Ultra XC at the same visit as initial treatment and who had no major protocol deviations. Participants were analyzed as randomized. | Posted | Count of Participants | Participants | Week 24 |
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| Secondary | Responder Status Based on Independent Photographic Reviewers Assessment at Week 24 - Full Analysis Dataset | The percentage of responders based on the independent photographic reviewers assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC and based on photographs. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This is the third outcome measure to be analyzed in the hierarchical testing sequence. Statistical significance for this measure will only be assessed if the first and second outcome measures achieve statistical significance at the predefined alpha level (0.025). | The population used consists of all randomized subjects who received Princess® FILLER Lidocaine AND the control Juvéderm® Ultra XC at the same visit as initial treatment; if subjects had received only one treatment (only Princess® FILLER Lidocaine or only Juvéderm® Ultra XC) during initial treatment they would have been excluded from the analysis set. Participants were analyzed as randomized. | Posted | Count of Participants | Participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Responder Status Based on Independent Photographic Reviewers Assessment at Week 24 - Per Protocol Dataset | The percentage of responders based on the independent photographic reviewers assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC and based on photographs. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This is the fourth outcome measure in the hierarchical testing sequence. Testing for this measure is contingent upon statistical significance being demonstrated for the first three outcome measures at the predefined alpha level (0.025). | The population used consists of all randomized subjects who received Princess® FILLER Lidocaine AND the control Juvéderm® Ultra XC at the same visit as initial treatment and who had no major protocol deviations. Participants were analyzed as randomized. | Posted | Count of Participants | Participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Responder Status Based on Treating Investigator Live Assessment at Week 24 - Full Analysis Set | The percentage of responders based on the treating investigator live assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This is the fifth outcome measure to be analyzed as part of the hierarchical testing sequence. Statistical significance will be assessed only if the first four outcome measures demonstrate statistical significance at the predefined alpha level (0.025). | The population used consists of all randomized subjects who received Princess® FILLER Lidocaine AND the control Juvéderm® Ultra XC at the same visit as initial treatment; if subjects had received only one treatment (only Princess® FILLER Lidocaine or only Juvéderm® Ultra XC) during initial treatment they would have been excluded from the analysis set. Participants were analyzed as randomized. | Posted | Count of Participants | Participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Responder Status Based on Treating Investigator Live Assessment at Week 24 - Per Protocol Set | The percentage of responders based on the treating investigator live assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This is the sixth outcome measure to be analyzed as part of the hierarchical testing sequence. Statistical significance will be assessed only if the first five outcome measures demonstrate statistical significance at the predefined alpha level (0.025). | The population used consists of all randomized subjects who received Princess® FILLER Lidocaine AND the control Juvéderm® Ultra XC at the same visit as initial treatment and who had no major protocol deviations. Participants were analyzed as randomized. | Posted | Count of Participants | Participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Improvement Over Baseline Based on Independent Blinded Evaluating Investigator Assessment at Week 24 | The percentage of subjects with an improvement over Baseline (subjects who have been rated as "very much improved" or "much improved" or "improved"), based on the independent blinded evaluating investigator assessment at Week 24 after initial treatment and using the 5-point Global Aesthetic Improvement Scale (GAIS). GAIS grades are ranked as "very much improved", "much improved", "improved", "no change", and "worse". | The population used consists of all randomized subjects who received Princess® FILLER Lidocaine AND the control Juvéderm® Ultra XC at the same visit as initial treatment; if subjects had received only one treatment (only Princess® FILLER Lidocaine or only Juvéderm® Ultra XC) during initial treatment they would have been excluded from the analysis set. Participants were analyzed as randomized. Only participants with available data were included in the analysis. | Posted | Count of Participants | Participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Improvement Over Baseline Based on Subject Assessment at Week 24 | The percentage of subjects with an improvement over Baseline (subjects who have been rated as "very much improved" or "much improved" or "improved"), based on subject assessment at Week 24 after initial treatment and using the 5-point Global Aesthetic Improvement Scale (GAIS). GAIS grades are ranked as "very much improved", "much improved", "improved", "no change", and "worse". | The population used consists of all randomized subjects who received Princess® FILLER Lidocaine AND the control Juvéderm® Ultra XC at the same visit as initial treatment; if subjects had received only one treatment (only Princess® FILLER Lidocaine or only Juvéderm® Ultra XC) during initial treatment they would have been excluded from the analysis set. Participants were analyzed as randomized. Only participants with available data were included in the analysis. | Posted | Count of Participants | Participants | Week 24 |
|
Up to 60 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Blinded Period: Princess Filler Lidocaine | Treatment with Princess Filler Lidocaine: Injection into the nasolabial fold on either the left or the right side of the face. | 0 | 270 | 3 | 270 | 38 | 270 |
| EG001 | Blinded Period: Comparator | Treatment with Comparator: Injection into the nasolabial fold on either the right or the left side of the face. | 0 | 270 | 3 | 270 | 37 | 270 |
| EG002 | Open Label Extension Period: Princess Filler Lidocaine | Treatment with Princess Filler Lidocaine: Injection into the nasolabial fold on the left and the right side of the face. | 0 | 48 | 1 | 48 | 3 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal detachment | Eye disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Vascular compression | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Swelling | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Discomfort | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Eyelid margin crusting | Eye disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development - Head of Clinical Operations | Croma Pharma GmbH | +43 2262 684680 | clinical.studies@croma.at |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 29, 2022 | Dec 12, 2024 | SAP_003.pdf |
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Type II |
|
| Type III |
|
| Type IV |
|
| Type V |
|
| Type VI |
|
| Grade 1 - mild |
|
| Grade 2 - moderate |
|
| Grade 3 - severe |
|
| Grade 4 - extreme |
|
| NLF-SRS Right Side of Face |
|
|
|
|
Treatment with Comparator: Injection into the nasolabial fold on either the right or the left side of the face.
|
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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