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

NCT ID: NCT05940038

Last Updated: 2023-10-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-23
• Study Completion Date: 2023-11-30

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Galderma Brasil Ltda.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clínica Hexsel de Dermatologia

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Carolina Siega

Role: CONTACT

carolina.siega@galderma.com

5551998900275

Cristhine Kamamoto

Role: CONTACT

cristhine.kamamoto@galderma.com

5511933157523

Facility Contacts

Doris Hexsel, MD

Role: primary

doris@hexsel.com.br

555132641234

Vitor Costa Fabris, MD

Role: backup

pesquisa@hexsel.com.br

555132641234

Other Identifiers

BR.16.003

Identifier Type: -

Identifier Source: org_study_id