Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study is designed to assess the long-term safety of Sculptra Aesthetic in immune-competent subjects as a single regimen for correction of nasolabial fold (NLF) contour deficiencies and other facial wrinkles.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sculptra Aesthetic | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| injectable poly-L-lactic acid Sculptra Aesthetic | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Any Injection Site Nodule and/or Papule | Nodules and/or papules are a subset of AEIs that does not include hypertrophic scarring, keloid formation, changes in skin pigmentation at the site of injection compared to adjacent skin, granuloma (confirmed by a biopsy), skin necrosis, hypersensitivity reactions, and unexpected changes in wrinkle contour. Reporting of a nodule or papule was based on size (nodule greater than or equal to [>=] 0.5 (cm); papule less than [<] 0.5 cm). Percentage of participants with any injection site nodule and/or papule were reported. | Up to 5 years |
| Percentage of Participants With Any Adverse Events of Interest (AEIs) | AEIs means: "serious or non-serious adverse event that is one of scientific and medical concern specific to the sponsor's product for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate. Examples of AEIs were hypertrophic scarring, keloid formation, hypersensitivity reactions, skin necrosis, unexpected change in wrinkle contour, granuloma, changes in the skin pigmentation at the site of injection compared to adjacent. Percentage of participants with any AEIs (other than injection site nodule and/or papule) were reported. | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Nasolabial Folds (NLF) Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | NLF severity was assessed by the evaluating investigator from WAS. WAS was based on a 6-point assessment grade where 0=no wrinkles; 1=just perceptible wrinkle; 2=shallow wrinkle; 3=moderately deep wrinkle; 4=deep wrinkle, well-defined edges; 5=very deep wrinkle, redundant fold. The calculations for average WAS was based on data corresponding to only the nasolabial folds (NLFs) treated at the initial visit, that is., only WAS scores for treated sides was considered. The average WAS was calculated from the individual left and right NLFs scores. If the WAS was only available for one side, then the average WAS was the score for the one side. |
Not provided
Inclusion Criteria:
1. Subjects seeking correction of shallow to deep NLF contour deficiencies.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Operations | Galderma R&D | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Study Site | Birmingham | Alabama | 32405 | United States | ||
| Galderma Study Site |
A total of 867 participants were enrolled and treated in this study.
The study was conducted at United States from 21 May 2015 to 28 May 2021.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Fitzpatrick Skin Types I-III | Participants with Fitzpatrick Skin Types I-III received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 milliliter (mL) deep dermal injections in a grid pattern, spaced at a distance of approximately 1 centimeter (cm) for up to 9 weeks. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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 | Apr 24, 2015 | Jul 4, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline, Months 6,13 and Years 2,3 4,5 |
| Change From Baseline in Cheek Folds Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | The WAS is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. The physician assessed the left side and the right side of the participant's face using the 5-point scale where scoring of wrinkle severity (grades 0-5, with 0 representing no wrinkles and 5 representing very deep wrinkles, redundant fold) was based on visual live assessment by the investigator at defined timepoints. Higher scores mean a worse outcome. | Baseline, Months 6,13 and Years 2,3 4,5 |
| Change From Baseline in Marionette Lines Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | Marionette Lines severity was assessed by the evaluating investigator from WAS. WAS was based on a 6-point assessment grade where 0=no wrinkles; 1=just perceptible wrinkle; 2=shallow wrinkle; 3=moderately deep wrinkle; 4=deep wrinkle, well-defined edges; 5=very deep wrinkle, redundant fold. The calculations for average WAS was based on data corresponding to only the nasolabial folds (NLFs) treated at the initial visit, that is., only WAS scores for treated sides was considered. The average WAS was calculated from the individual left and right NLFs scores. If the WAS was only available for one side, then the average WAS was the score for the one side. | Baseline, Months 6,13 and Years 2,3 4,5 |
| Change From Baseline in Chin Crease Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | Chin Crease severity was assessed by the evaluating investigator from WAS. WAS was based on a 6-point assessment grade where 0=no wrinkles; 1=just perceptible wrinkle; 2=shallow wrinkle; 3=moderately deep wrinkle; 4=deep wrinkle, well-defined edges; 5=very deep wrinkle, redundant fold. The calculations for average WAS was based on data corresponding to only the nasolabial folds (NLFs) treated at the initial visit, that is., only WAS scores for treated sides was considered. The average WAS was calculated from the individual left and right NLFs scores. If the WAS was only available for one side, then the average WAS was the score for the one side. | Baseline, Months 6,13 and Years 2,3 4,5 |
| Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale | Efficacy was assessed by overall facial improvement assessed live by the Investigator assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS). The Global Aesthetic Improvement Scale is a subjective test. The investigator independently describes the degree of improvement in facial appearance. Possible scores were + 3: Much improved, +2: Moderately improved, +1: Slightly improved, 0: No change, -1: Slightly worse, -2: Moderately worse, -3: Much worse. 'Not Improved' included participants with scores of 0, -1, -2, and -3 and 'Improved' included participants with scores of 3, 2, and 1. Higher the GAIS value, the greater the improvement. | At 6,13 months, 2, 3, 4 and 5 years |
| Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale | Efficacy was assessed by overall facial improvement assessed live by the participants assessment of facial appearance including the GAIS. The GAIS is a subjective test. The participant independently describes the degree of improvement in facial appearance. Possible scores were + 3: Much improved, +2: Moderately improved, +1: Slightly improved, 0: No change, -1: Slightly worse, -2: Moderately worse, -3: Much worse. 'Not Improved' included participants with scores of 0, -1, -2, and -3 and 'Improved' included participants with scores of 3, 2, and 1. Higher the GAIS value, the greater the improvement (Range 0 to 3). | At 6,13 months, 2, 3, 4 and 5 years |
| Encino |
| California |
| 91436 |
| United States |
| Galderma Study Site | Hermosa Beach | California | 90254 | United States |
| Galderma Study Site | San Diego | California | 92121 | United States |
| Galderma Study Site | Solana Beach | California | 92075 | United States |
| Galderma Study Site | Aventura | Florida | 33180 | United States |
| Galderma Study Site | Boca Raton | Florida | 33486 | United States |
| Galderma Study Site | Coral Gables | Florida | 33146 | United States |
| Galderma Study Site | Miami | Florida | 33137 | United States |
| Galderma Study Site | Buffalo Grove | Illinois | 60089 | United States |
| Galderma Study Site | Hackensack | New Jersey | 07601 | United States |
| Galderma Study Site | New York | New York | 10016 | United States |
| Galderma Study Site | White Plains | New York | 10604 | United States |
| Galderma Study Site | Nashville | Tennessee | 37215 | United States |
| Galderma Study Site | Austin | Texas | 78746 | United States |
| Galderma Study Site | Houston | Texas | 77056 | United States |
| Galderma Study Site | Plano | Texas | 75093 | United States |
| Galderma Study Site | Spokane | Washington | 99202 | United States |
| Fitzpatrick Skin Type IV-VI |
Participants with Fitzpatrick Skin Types IV-VI received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Fitzpatrick Skin Type I-III | Participants with Fitzpatrick Skin Type I-III received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks. |
| BG001 | Fitzpatrick Skin Type IV-VI | Participants with Fitzpatrick Skin Type IV-VI received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks. |
| 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, 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 |
| ||||||||||||||||
| Fitzpatrick Classification Skin Type | Skin Type I = White; very fair, red or blonde hair blue eyes; freckles; Always burns, never tans Skin Type II = White, fair, red or blond hair; blue, hazel or green eyes; Usually burns, tans with difficulty Skin Type III = Cream white; fair with any eye or hair color (common); Sometimes mild burn, gradually tans Skin Type IV = Brown; typical Mediterranean Caucasian skin; Rarely burns, tans with ease Skin Type V = Dark Brown; mid-eastern skin types; Very rarely burns, tans easily Skin Type VI = Black; Never burns, tans very easily | 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 | Percentage of Participants With Any Injection Site Nodule and/or Papule | Nodules and/or papules are a subset of AEIs that does not include hypertrophic scarring, keloid formation, changes in skin pigmentation at the site of injection compared to adjacent skin, granuloma (confirmed by a biopsy), skin necrosis, hypersensitivity reactions, and unexpected changes in wrinkle contour. Reporting of a nodule or papule was based on size (nodule greater than or equal to [>=] 0.5 (cm); papule less than [<] 0.5 cm). Percentage of participants with any injection site nodule and/or papule were reported. | Intent to treat (ITT) Population included all participants who received at least one injection of study drug. | Posted | Number | percentage of participants | Up to 5 years |
|
|
| |||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Any Adverse Events of Interest (AEIs) | AEIs means: "serious or non-serious adverse event that is one of scientific and medical concern specific to the sponsor's product for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate. Examples of AEIs were hypertrophic scarring, keloid formation, hypersensitivity reactions, skin necrosis, unexpected change in wrinkle contour, granuloma, changes in the skin pigmentation at the site of injection compared to adjacent. Percentage of participants with any AEIs (other than injection site nodule and/or papule) were reported. | ITT Population included all participants who receive at least one injection of study drug. | Posted | Number | Percentage of participants | Up to 5 years |
| |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Nasolabial Folds (NLF) Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | NLF severity was assessed by the evaluating investigator from WAS. WAS was based on a 6-point assessment grade where 0=no wrinkles; 1=just perceptible wrinkle; 2=shallow wrinkle; 3=moderately deep wrinkle; 4=deep wrinkle, well-defined edges; 5=very deep wrinkle, redundant fold. The calculations for average WAS was based on data corresponding to only the nasolabial folds (NLFs) treated at the initial visit, that is., only WAS scores for treated sides was considered. The average WAS was calculated from the individual left and right NLFs scores. If the WAS was only available for one side, then the average WAS was the score for the one side. | ITT Population included all participants who received at least one injection of study drug. "Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable for given time points. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Months 6,13 and Years 2,3 4,5 |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Cheek Folds Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | The WAS is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. The physician assessed the left side and the right side of the participant's face using the 5-point scale where scoring of wrinkle severity (grades 0-5, with 0 representing no wrinkles and 5 representing very deep wrinkles, redundant fold) was based on visual live assessment by the investigator at defined timepoints. Higher scores mean a worse outcome. | ITT Population included all participants who received at least one injection of study drug. "Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable for given time points. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Months 6,13 and Years 2,3 4,5 |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Marionette Lines Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | Marionette Lines severity was assessed by the evaluating investigator from WAS. WAS was based on a 6-point assessment grade where 0=no wrinkles; 1=just perceptible wrinkle; 2=shallow wrinkle; 3=moderately deep wrinkle; 4=deep wrinkle, well-defined edges; 5=very deep wrinkle, redundant fold. The calculations for average WAS was based on data corresponding to only the nasolabial folds (NLFs) treated at the initial visit, that is., only WAS scores for treated sides was considered. The average WAS was calculated from the individual left and right NLFs scores. If the WAS was only available for one side, then the average WAS was the score for the one side. | ITT Population included all participants who received at least one injection of study drug. "Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable for given time points. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Months 6,13 and Years 2,3 4,5 |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Chin Crease Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | Chin Crease severity was assessed by the evaluating investigator from WAS. WAS was based on a 6-point assessment grade where 0=no wrinkles; 1=just perceptible wrinkle; 2=shallow wrinkle; 3=moderately deep wrinkle; 4=deep wrinkle, well-defined edges; 5=very deep wrinkle, redundant fold. The calculations for average WAS was based on data corresponding to only the nasolabial folds (NLFs) treated at the initial visit, that is., only WAS scores for treated sides was considered. The average WAS was calculated from the individual left and right NLFs scores. If the WAS was only available for one side, then the average WAS was the score for the one side. | ITT Population included all participants who received at least one injection of study drug. "Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable for given time points. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Months 6,13 and Years 2,3 4,5 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale | Efficacy was assessed by overall facial improvement assessed live by the Investigator assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS). The Global Aesthetic Improvement Scale is a subjective test. The investigator independently describes the degree of improvement in facial appearance. Possible scores were + 3: Much improved, +2: Moderately improved, +1: Slightly improved, 0: No change, -1: Slightly worse, -2: Moderately worse, -3: Much worse. 'Not Improved' included participants with scores of 0, -1, -2, and -3 and 'Improved' included participants with scores of 3, 2, and 1. Higher the GAIS value, the greater the improvement. | ITT Population included all participants who receive at least one injection of study drug. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and here "number analyzed" signifies participants who were evaluable for this outcome measure for given time points. | Posted | Number | percentage of participants | At 6,13 months, 2, 3, 4 and 5 years |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale | Efficacy was assessed by overall facial improvement assessed live by the participants assessment of facial appearance including the GAIS. The GAIS is a subjective test. The participant independently describes the degree of improvement in facial appearance. Possible scores were + 3: Much improved, +2: Moderately improved, +1: Slightly improved, 0: No change, -1: Slightly worse, -2: Moderately worse, -3: Much worse. 'Not Improved' included participants with scores of 0, -1, -2, and -3 and 'Improved' included participants with scores of 3, 2, and 1. Higher the GAIS value, the greater the improvement (Range 0 to 3). | ITT Population included all participants who receive at least one injection of study drug. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and here "number analyzed" signifies participants who were evaluable for this outcome measure for given time points. | Posted | Number | percentage of participants | At 6,13 months, 2, 3, 4 and 5 years |
|
Up to 5 years
ITT Population included all participants who received at least one injection of study drug.
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 | Fitzpatrick Skin Types I-III | Participants with Fitzpatrick Skin Types I-III received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks. | 3 | 557 | 39 | 557 | 315 | 557 |
| EG001 | Fitzpatrick Skin Type IV-VI | Participants with Fitzpatrick Skin Types IV-VI received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks. | 1 | 310 | 11 | 310 | 150 | 310 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Granuloma | Congenital, familial and genetic disorders | 18.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 18.0 | Systematic Assessment |
| |
| Breast cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.0 | Systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.0 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.0 | Systematic Assessment |
| |
| Pancreatic carcinoma stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.0 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.0 | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.0 | Systematic Assessment |
| |
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA18.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA18.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA18.0 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA18.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | 18.0 | Systematic Assessment |
| |
| Slipping rib syndrome | Musculoskeletal and connective tissue disorders | MedDRA18.0 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA18.0 | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA18.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA18.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA18.0 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA18.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA18.0 | Systematic Assessment |
| |
| Corona virus infection | Infections and infestations | MedDRA18.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA18.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA18.0 | Systematic Assessment |
| |
| Death | General disorders | 18.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA18.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA18.0 | Systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA18.0 | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA18.0 | Systematic Assessment |
| |
| Nerve injury | Injury, poisoning and procedural complications | MedDRA18.0 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA18.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA18.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA18.0 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | 18.0 | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA18.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA18.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA18.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | 18.0 | Systematic Assessment |
| |
| Cerebellar haemorrhage | Nervous system disorders | 18.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA18.0 | Systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA18.0 | Systematic Assessment |
| |
| Normochromic normocytic anaemia | Blood and lymphatic system disorders | MedDRA18.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA18.0 | Systematic Assessment |
| |
| Pancreas divisum | Congenital, familial and genetic disorders | MedDRA18.0 | Systematic Assessment |
| |
| Retinal artery occlusion | Eye disorders | MedDRA18.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA18.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA18.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA18.0 | Systematic Assessment |
| |
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA18.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA18.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA18.0 | Systematic Assessment |
| |
| Granuloma skin | Skin and subcutaneous tissue disorders | 18.0 | Systematic Assessment |
| |
| Knee operation | Surgical and medical procedures | MedDRA18.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA18.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA18.0 | Systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant site nodule | General disorders | MedDRA18.0 | Systematic Assessment |
| |
| Implant site papules | General disorders | MedDRA18.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA18.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA18.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA18.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA18.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA18.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA18.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA18.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA18.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA18.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA18.0 | Systematic Assessment |
| |
| Corona virus infection | General disorders | MedDRA18.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | General disorders | MedDRA18.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA18.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA18.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA18.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA18.0 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA18.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA18.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA18.0 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA18.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA18.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA18.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA18.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA18.0 | Systematic Assessment |
| |
| Implant site pain | General disorders | MedDRA18.0 | Systematic Assessment |
| |
| Implant site discolouration | General disorders | MedDRA18.0 | Systematic Assessment |
| |
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Galderma | 817 961 5000 | 1 | Clinical.Studies@galderma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 17, 2018 | Jul 4, 2023 | SAP_001.pdf |
| 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 |
|
|
|
Participants with Fitzpatrick Skin Types IV-VI received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 milliliter (mL) deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks.
|
|
|
|
Participants with Fitzpatrick Skin Types IV-VI received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 milliliter (mL) deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks.
|
|
Participants with Fitzpatrick Skin Types IV-VI received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 milliliter (mL) deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks.
|
|
Participants with Fitzpatrick Skin Type IV-VI received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks. |
|
|
Participants with Fitzpatrick Skin Type IV-VI received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks.
|
|