Retrospective Study of the Safety and Efficacy of PLLA for Skin Flaccidity in Labia Majora and/or Pubis Region

Launched by GALDERMA BRASIL LTDA. · Jul 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a treatment called Sculptra® (poly-L-l-lactic acid) for women who experience skin laxity, or flaccidity, in the labia majora and pubis region. The trial is looking back at the medical records of women who have already received at least one treatment session to see how well it worked and if there were any safety concerns.

To be eligible for this study, women need to be at least 18 years old and have undergone at least one Sculptra® treatment. They should also be able to understand and sign the necessary consent forms. Participants can expect that their previous treatment data and photographs will be reviewed to assess the condition of their skin before and after the treatment. It’s important to note that women with certain medical conditions or who have had other procedures in the area recently may not be able to participate. Overall, this trial aims to gather valuable information about how Sculptra® can help improve skin firmness in this specific area.

Gender

FEMALE

Eligibility 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.