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Phase IV, retrospective, single-center, clinical trial, chart review to evaluate the safety and efficacy of poly-L-l-lactic acid [PLLA-SCA, Sculptra®] in women who underwent at least one treatment for skin flaccidity of the labia majora and/or pubis region for safety evaluation and three treatment sessions for efficacy evaluation.
This is a phase IV, retrospective, single-center, clinical trial of medical record data collection to evaluate the safety and effectiveness in subjects who have undergone at least one application of poly-L-l-lactic acid (Sculptra®) for skin flaccidity treatment in the labia majora and/or pubis region. All medical charts of subjects treated for this condition at the clinic treated from Jan1st 2022 and on will be screened for inclusion. The reason for not including a subject will be documented.
During the study, the medical records of subjects who presented skin flaccidity of the labia majora and/or pubis region will be evaluated to anamnesis and physical examination and information will be obtained on demographic data, clinical history, previous treatment(s) in the study region, number of treatment sessions with Sculptra®, as well as data on product dilution, technique used, doses injected, and adverse events related to Sculptra® and/or the injection procedure. Clinical evaluations will also be performed through the information and photographic records obtained through the evaluation of the medical records of these subjects.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of AEs | Since first application up to 12 months follow up. | |
| Number (%) of AEs related to the study product or injection procedure | Since first application up to 12 months follow up. | |
| Number of AEs related (%) to the study product by intensity (if available) | Since first application up to 12 months follow up. | |
| Number (%) of subjects having at least one AE | Since first application up to 12 months follow up. | |
| Number (%) of subjects having at least one AE related to the study product or injection procedure | Since first application up to 12 months follow up. | |
| Number (%) of subjects who died | Since first application up to 12 months follow up. | |
| Improvement of cutaneous flaccidity of the labia majora and/or pubis region | Assessed by the percentage of total scores (n, %): hugely better, much better, or better according to Global Aesthetic Improvement Scale | Since third application up to 12 months follow up since first application. |
| Improvement of global aesthetic aspect of the labia majora and/or pubis region | Assessed by the percentage of total scores (n, %): hugely better, much better, or better according to Global Aesthetic Improvement Scale | Since third application up to 12 months follow up since first application. |
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| Measure | Description | Time Frame |
|---|---|---|
| Improvement of symptoms related to functional complaints of the labia majora and/or mons pubis region | Assessed by the total percentage (n, %) of reported outcomes as hugely better, much better, or better | Since third application up to 12 months follow up since first application. |
Inclusion Criteria:
Exclusion Criteria:
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All medical records of female subjects who received at least one (1) application of Sculptra® for the treatment of skin flaccidity of the labia majora and/or pubis, from Jan1st 2022 and on, on the private practice of the investigators will be screened for inclusion.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carolina Siega | Contact | 5551998900275 | carolina.siega@galderma.com | |
| Cristhine Kamamoto | Contact | 5511933157523 | cristhine.kamamoto@galderma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClĂnica Hexsel de Dermatologia | Recruiting | Porto Alegre | Rio Grande do Sul | 90550-141 | Brazil |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 10, 2024 | |
| Reset | Oct 17, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 10, 2024 | Oct 17, 2024 |
| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |