NCT05940038

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: Galderma Brasil Ltda. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Skin Laxity

Timeline

• Start date: 2023-08-23
• Primary completion: 2023-10-01
• Completion: 2023-11-01
• First posted: 2023-07-11
• Last updated: 2023-10-30

Locations

1 site across 1 country: Brazil