Evaluating the safety and effectiveness of Sculptra for skin laxity in the labia majora and pubis region
Retrospective Study to Evaluate the Safety and Efficacy of Poly-L-l-lactic Acid [Sculptra®] in the Treatment of Skin Flaccidity in the Labia Majora and/or Pubis Region
This study looks at how safe and effective Sculptra is for women who have had treatment for loose skin in the labia majora and pubis area.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Galderma Brasil Ltda. Industry-sponsored |
| Locations | 1 site (Porto Alegre, Rio Grande Do Sul) |
| Trial ID | NCT05940038 on ClinicalTrials.gov |
What this trial studies
This observational study reviews medical records to assess the safety and efficacy of poly-L-l-lactic acid (Sculptra®) in women who have received treatment for skin flaccidity in the labia majora and/or pubis region. The study will analyze data from patients treated since January 1, 2022, including demographic information, treatment history, and clinical evaluations. The aim is to gather comprehensive data on the outcomes and any adverse events related to the treatment. This retrospective approach allows for a thorough understanding of the treatment's effectiveness based on real-world clinical data.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older who have undergone at least one treatment session with Sculptra for skin flaccidity in the labia majora and/or pubis region.
Not a fit: Patients who have had any procedures on the labia majora and/or pubis skin within the last 12 months or have clinical conditions that may affect trial participation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of Sculptra for improving skin laxity in the targeted areas.
How similar studies have performed: While this study is retrospective and focuses on a specific treatment area, similar studies evaluating the efficacy of Sculptra in other regions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subjects able to read, or follow reading, understand, and sign the Informed Consent Form and the Authorization Form for Imaging Usage approved by the REC/CONEP system; 2. Subjects aged 18 years or older; 3. Having received at least 1 (one) session of Sculptra® for labia majora and/or mons pubis skin flaccidity. 4. Available clinical information and treatment data in the medical records. 5. Having medical records that present suitable photographic records prior and after the Sculptra® injections that allow a skin condition assessment of labia majora and/or mons pubis. Exclusion Criteria: 1. Having any clinical condition or laboratory disorder, recorded at the medical record, which may compromise trial participation according to the investigator assessment. 2. Having any procedure performed on the labia majora and/or mons pubis skin within12 months prior to the first administration of PLLA (Sculptra®). 3. Participation in another clinical trial in the 30 days previous the study start.
Where this trial is running
Porto Alegre, Rio Grande Do Sul
- Clínica Hexsel de Dermatologia — Porto Alegre, Rio Grande Do Sul, Brazil (Recruiting)
Study contacts
- Study coordinator: Carolina Siega
- Email: carolina.siega@galderma.com
- Phone: 5551998900275
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.