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This pilot study has been designed to evaluate the safety and effectiveness of PLLA as a single regimen for the improvement in appearance of cellulite after changes in reconstitution procedure.
Cellulite is a topographic and localized skin condition that is commonly found on the posterolateral thighs, buttocks, and abdomen. It is often identified by a dimpled or orange-peel appearance of the skin's surface. The presence of visible cellulite is associated with histologic changes in the dermis, adipose tissue, and septae.
Based on the theory that a stronger skin structure, with a decrease in skin laxity and increase in dermal thickness, could reduce the appearance of cellulite, the Sponsor intends to investigate the safety and effectiveness of PLLA for the improvement in appearance of cellulite in the posterior thighs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | PLLA new dilution for treatment to improve appearance of cellulite. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sculptra new dilution | Device | Treatment to improve appearance of cellulite. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 9 | Aesthetic improvement was assessed by comparing a photograph taken before the first treatment at the baseline visit to current visit. On a 7-graded GAIS from "very much worse" to "very much improved" as follows; very much improved, much improved, improved, no change, worse, much worse and very much worse. Responder was defined as a participant with a rating of at least improved as assessed by the treating investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of aesthetic improved thighs of responders based on treating investigator assessment using GAIS at Month 9 were reported. | At Month 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12 | Aesthetic improvement was assessed by comparing a photograph taken before the first treatment at the baseline visit to a photograph from the current visit. on a 7-graded GAIS from "very much worse" to "very much improved" as follows; very much improved, much improved, improved, no change, worse, much worse and very much worse. Responder was defined as a participant with a rating of at least improved as assessed by the treating investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of aesthetic improved thighs of responders based on treating investigator assessment using GAIS at Month 1,2,6 and 12 were reported. |
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Inclusion Criteria:
Exclusion Criteria:
Known/previous allergy or hypersensitivity to any of the Sculptra constituents.
Known/previous allergy or hypersensitivity to lidocaine and other local anesthetics, e.g. amide-type anesthetics, or topical anesthetics or nerve blocking agents.
Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions.
Previous treatment/procedure in or near the treatment area:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Research Site | Vancouver | British Columbia | V5Z4E1 | Canada |
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A total of 29 participants were enrolled in the study. All enrolled participants were treated and completed the study.
This study was conducted at Canada from 19 November 2021 to 27 February 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group (Sculptra) | Participants with intent to undergo treatment to improve appearance of cellulite were enrolled and treated with Sculptra in three sessions spaced one month (+2 weeks) apart. Participants were treated at baseline, Month 1 and Month 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group (Sculptra) | Participants with intent to undergo treatment to improve appearance of cellulite were enrolled and treated with Sculptra in three sessions spaced one month (+2 weeks) apart. Participants were treated at baseline, Month 1 and Month 2. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 9 | Aesthetic improvement was assessed by comparing a photograph taken before the first treatment at the baseline visit to current visit. On a 7-graded GAIS from "very much worse" to "very much improved" as follows; very much improved, much improved, improved, no change, worse, much worse and very much worse. Responder was defined as a participant with a rating of at least improved as assessed by the treating investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of aesthetic improved thighs of responders based on treating investigator assessment using GAIS at Month 9 were reported. | Full Analysis Set (FAS) Included all participants who were injected in both thighs. | Posted | Count of Units | Thighs | At Month 9 | Thighs | Thighs |
|
Up to 12 months
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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 | Treatment Group (Sculptra) | Participants with intent to undergo treatment to improve appearance of cellulite were enrolled and treated with Sculptra in three sessions spaced one month (+2 weeks) apart. Participants were treated at baseline, Month 1 and Month 2. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Galderma Research and Development, LLC (GLLC) | +1 817-961-5000 | 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 | Jun 21, 2021 | Jun 10, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 29, 2022 | Jun 14, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000071697 | Cellulite |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| At month 1, 2, 6 and 12 |
| Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12 | Aesthetic improvement was assessed by comparing a photograph taken before the first treatment at the baseline visit to a photograph from the current visit. on a 7-graded GAIS from "very much worse" to "very much improved" as follows; very much improved, much improved, improved, no change, worse, much worse and very much worse. Responder was defined as a participant with a rating of at least improved as assessed by themselves (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of aesthetic improved thighs of responders based on participant photography assessment using GAIS at Month 1,2,6 and 12 were reported. | At Months 1, 2, 6, 9 and 12 |
| 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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Participants with intent to undergo treatment to improve appearance of cellulite were enrolled and treated with Sculptra in three sessions spaced one month (+2 weeks) apart. Participants were treated at baseline, Month 1 and Month 2. |
|
|
| Secondary | Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12 | Aesthetic improvement was assessed by comparing a photograph taken before the first treatment at the baseline visit to a photograph from the current visit. on a 7-graded GAIS from "very much worse" to "very much improved" as follows; very much improved, much improved, improved, no change, worse, much worse and very much worse. Responder was defined as a participant with a rating of at least improved as assessed by the treating investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of aesthetic improved thighs of responders based on treating investigator assessment using GAIS at Month 1,2,6 and 12 were reported. | Full Analysis Set (FAS) Included all participants who were injected in both thighs. | Posted | Count of Units | Thighs | At month 1, 2, 6 and 12 | Thighs | Thighs |
|
|
|
| Secondary | Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12 | Aesthetic improvement was assessed by comparing a photograph taken before the first treatment at the baseline visit to a photograph from the current visit. on a 7-graded GAIS from "very much worse" to "very much improved" as follows; very much improved, much improved, improved, no change, worse, much worse and very much worse. Responder was defined as a participant with a rating of at least improved as assessed by themselves (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of aesthetic improved thighs of responders based on participant photography assessment using GAIS at Month 1,2,6 and 12 were reported. | Full Analysis Set (FAS) Included all participants who were injected in both thighs. Here, "Number analyzed" signifies those units (thighs) which were evaluable at the specified timeframe. | Posted | Count of Units | Thighs | At Months 1, 2, 6, 9 and 12 | Thighs | Thighs |
|
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| 0 |
| 29 |
| 0 |
| 29 |
| 10 |
| 29 |
| COVID-19 | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
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| Urethral prolapse | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
|
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| Improved |
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| No change |
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| Much improved |
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| Improved |
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| No change |
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| Month 1, Right thigh |
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| Month 2, Left thigh |
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| Month 2, Right thigh |
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| Month 6, Left thigh |
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| Month 6, Right thigh |
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| Month 12, Left thigh |
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| Month 12, Right thigh |
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| Much improved |
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| Improved |
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| No change |
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| Month 1, Right thigh |
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| Month 2, Left thigh |
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| Month 2, Right thigh |
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| Month 6, Left thigh |
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| Month 6, Right thigh |
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| Month 9, Left thigh |
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| Month 9, Right thigh |
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| Month 12, Left thigh |
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| Month 12, Right thigh |
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