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This is a prospective open-label study to evaluate safety and effectiveness of two different reconstitution volumes of poly-l-lactic acid (PLLA) for correction of wrinkles in the décolletage area.
A challenge for wrinkle correction of the decolletage/chest and other non-facial areas is that larger surface areas typically need to be treated than for facial indications, for which reason the Sponsor is investigating a larger reconstitution volume compared to the approved label. In this study, the total volume of 18mL, including 1mL of 2% lidocaine, is being explored and compared with results from the current labeled volume of 9mL, including lidocaine, to assess if the larger volume is well-tolerated for treatment for wrinkles in the decolletage area.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 8ml | Active Comparator | Device: Sculptra current label dilution for treatment of wrinkles in the decolletage area |
|
| 17ml | Active Comparator | Experimental: PLLA new dilution volume for treatment of wrinkles in the decolletage area |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| poly-l-lactic acid (Sculptra) | Device | Sculptra |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders on the Galderma Décolletage Scale (GDS), as Assessed Live by the Treating Investigator, at Month 9 | Responder was defined as participants having at least one grade improvement from baseline. GDS was a validated 5-point scale used to assess the severity of lines and wrinkles in the décolletage area: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (very severe). Higher score meant very severe lines and wrinkles in the décolletage area. | At Month 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders on the Galderma Décolletage Scale, as Assessed Live by the Treating Investigator, at Month 6 | Responder was defined as participants having at least one grade improvement from baseline. GDS was a validated 5-point scale used to assess the severity of lines and wrinkles in the décolletage area: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (very severe). Higher score meant very severe lines and wrinkles in the décolletage area. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Study Site | Encino | California | 91436 | United States | ||
| Galderma Study Site |
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A total of 30 participants were enrolled and treated in this study.
This study was conducted at the United States from 31 August 2022 to 08 August 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sculptra 8ml | Participants received first treatment injection sub-dermally with Sculptra 8 milliliters (ml; current labeled total volume: reconstituted with 8 mL sterile water for injection [SWFI] + 1 mL lidocaine hydrochloride 2 percent [%]) at Day 1. After first treatment, if needed, an additional 3 treatment sessions were performed at 1 month (+ 2 weeks) interval. Treatment was continued till optimal correction, which was defined as at least one grade improvement on Galderma Decolletage Scale (GDS) and best correction that achieved as agreed upon by the Treating Investigator and the participant. |
| FG001 | Sculptra 17ml | Participants received first treatment injection sub-dermally with Sculptra 17ml (reconstituted with 17 mL SWFI + 1 mL lidocaine hydrochloride 2%) at Day 1. After first treatment, if needed, an additional 3 treatment sessions were performed at 1 month (+ 2 weeks) interval. Treatment was continued till optimal correction, which was defined as at least one grade improvement on GDS and best correction that achieved as agreed upon by the Treating Investigator and the participant. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent to treat (ITT) population Included all participants who were randomized and analyzed according to the treatment they were randomized based on the randomization scheme.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sculptra 8ml | Participants received first treatment injection sub-dermally with Sculptra 8 milliliters (ml; current labeled total volume: reconstituted with 8 mL sterile water for injection [SWFI] + 1 mL lidocaine hydrochloride 2 percent [%]) at Day 1. After first treatment, if needed, an additional 3 treatment sessions were performed at 1 month (+ 2 weeks) interval. Treatment was continued till optimal correction, which was defined as at least one grade improvement on Galderma Decolletage Scale (GDS) and best correction that achieved as agreed upon by the Treating Investigator and the participant. |
| 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 | Percentage of Responders on the Galderma Décolletage Scale (GDS), as Assessed Live by the Treating Investigator, at Month 9 | Responder was defined as participants having at least one grade improvement from baseline. GDS was a validated 5-point scale used to assess the severity of lines and wrinkles in the décolletage area: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (very severe). Higher score meant very severe lines and wrinkles in the décolletage area. | Intent to treat (ITT) population Included all participants who were randomized and analyzed according to the treatment they were randomized based on the randomization scheme. | Posted | Number | 95% Confidence Interval | percentage of Participants | At Month 9 |
|
From Day 1 up to end of study (Up to 11 months)
Safety population Included all participants who were treated with Sculptra.
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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 | Sculptra 8ml | Participants received first treatment injection sub-dermally with Sculptra 8 milliliters (ml; current labeled total volume: reconstituted with 8 mL sterile water for injection [SWFI] + 1 mL lidocaine hydrochloride 2 percent [%]) at Day 1. After first treatment, if needed, an additional 3 treatment sessions were performed at 1 month (+ 2 weeks) interval. Treatment was continued till optimal correction, which was defined as at least one grade improvement on Galderma Decolletage Scale (GDS) and best correction that achieved as agreed upon by the Treating Investigator and the participant. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site nodule | General disorders | MedDRA (25.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Galderma Research and Development, LLC | 817-961-5000 | aestheticclinicaltrials@galderma.com |
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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 | May 31, 2022 | Jul 25, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 6, 2023 | Jul 25, 2024 | SAP_001.pdf |
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| At Month 6 |
| Percentage of Responders Who Achieved At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant at Months 6 and 9 | Responder was defined as participants achieving 'very much improved', 'much improved' or "Improved" on GAIS compared to baseline. The 7-graded GAIS was used by the participant to live assess the severity of lines and wrinkles by responding to the question: "Please choose the response below that best describes the overall change in the appearance of your upper chest area since you received the study treatment " by using the respective categorical scale as follows: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse. In this outcome measure, percentage of participants who achieved at least 'Improved' on the GAIS assessed by participant at Months 6 and 9 were reported. | At Month 6 and 9 |
| Percentage of Responders With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Treating Investigator at Months 6 and 9 | Responder was defined as participants achieving 'very much improved', 'much improved' or "Improved" on GAIS compared to baseline. The 7-graded GAIS was used by the Treating Investigator to live assess the severity of lines and wrinkles by responding to the question: "Please choose the response below that best describes the overall change in the appearance of your upper chest area since you received the study treatment " by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse. In this outcome measure, percentage of participants who achieved at least 'Improved' on the GAIS assessed by treating investigator at Months 6 and 9 were reported. | At Months 6 and 9 |
| Solana Beach |
| California |
| 92075 |
| United States |
| BG001 | Sculptra 17ml | Participants received first treatment injection sub-dermally with Sculptra 17ml (reconstituted with 17 mL SWFI + 1 mL lidocaine hydrochloride 2%) at Day 1. After first treatment, if needed, an additional 3 treatment sessions were performed at 1 month (+ 2 weeks) interval. Treatment was continued till optimal correction, which was defined as at least one grade improvement on GDS and best correction that achieved as agreed upon by the Treating Investigator and the participant. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Sculptra 17ml | Participants received first treatment injection sub-dermally with Sculptra 17ml (reconstituted with 17 mL SWFI + 1 mL lidocaine hydrochloride 2%) at Day 1. After first treatment, if needed, an additional 3 treatment sessions were performed at 1 month (+ 2 weeks) interval. Treatment was continued till optimal correction, which was defined as at least one grade improvement on GDS and best correction that achieved as agreed upon by the Treating Investigator and the participant. |
|
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| Secondary | Percentage of Responders on the Galderma Décolletage Scale, as Assessed Live by the Treating Investigator, at Month 6 | Responder was defined as participants having at least one grade improvement from baseline. GDS was a validated 5-point scale used to assess the severity of lines and wrinkles in the décolletage area: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (very severe). Higher score meant very severe lines and wrinkles in the décolletage area. | ITT population Included all participants who were randomized and analyzed according to the treatment they were randomized based on the randomization scheme. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of Participants | At Month 6 |
|
|
|
| Secondary | Percentage of Responders Who Achieved At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant at Months 6 and 9 | Responder was defined as participants achieving 'very much improved', 'much improved' or "Improved" on GAIS compared to baseline. The 7-graded GAIS was used by the participant to live assess the severity of lines and wrinkles by responding to the question: "Please choose the response below that best describes the overall change in the appearance of your upper chest area since you received the study treatment " by using the respective categorical scale as follows: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse. In this outcome measure, percentage of participants who achieved at least 'Improved' on the GAIS assessed by participant at Months 6 and 9 were reported. | ITT population Included all participants who were randomized and analyzed according to the treatment they were randomized based on the randomization scheme. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of Participants | At Month 6 and 9 |
|
|
|
| Secondary | Percentage of Responders With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Treating Investigator at Months 6 and 9 | Responder was defined as participants achieving 'very much improved', 'much improved' or "Improved" on GAIS compared to baseline. The 7-graded GAIS was used by the Treating Investigator to live assess the severity of lines and wrinkles by responding to the question: "Please choose the response below that best describes the overall change in the appearance of your upper chest area since you received the study treatment " by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse. In this outcome measure, percentage of participants who achieved at least 'Improved' on the GAIS assessed by treating investigator at Months 6 and 9 were reported. | ITT population Included all participants who were randomized and analyzed according to the treatment they were randomized based on the randomization scheme. Here, 'number analyzed, n' signifies participants evaluable for specified time points. | Posted | Number | 95% Confidence Interval | percentage of Participants | At Months 6 and 9 |
|
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| 0 |
| 16 |
| 0 |
| 16 |
| 5 |
| 16 |
| EG001 | Sculptra 17ml | Participants received first treatment injection sub-dermally with Sculptra 17ml (reconstituted with 17 mL SWFI + 1 mL lidocaine hydrochloride 2%) at Day 1. After first treatment, if needed, an additional 3 treatment sessions were performed at 1 month (+ 2 weeks) interval. Treatment was continued till optimal correction, which was defined as at least one grade improvement on GDS and best correction that achieved as agreed upon by the Treating Investigator and the participant. | 0 | 14 | 0 | 14 | 4 | 14 |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Application site dermatitis | General disorders | MedDRA (25.0) | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
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| SARS-CoV-2 test positive | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
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| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
|
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| At Month 9 |
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