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

NCT05940038 | Unknown

• 1 other identifier: BR.16.003
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Laxity

Outcome Measures

Primary Outcomes (8)

• 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.

Other Outcomes (1)

• Improvement of symptoms related to functional complaints of the labia majora and/or mons pubis region

  Since third application up to 12 months follow up since first application.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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;
• Subjects aged 18 years or older;
• Having received at least 1 (one) session of Sculptra® for labia majora and/or mons pubis skin flaccidity.
• Available clinical information and treatment data in the medical records.
• 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.

You may not qualify if:

• Having any clinical condition or laboratory disorder, recorded at the medical record, which may compromise trial participation according to the investigator assessment.
• Having any procedure performed on the labia majora and/or mons pubis skin within12 months prior to the first administration of PLLA (Sculptra®).
• Participation in another clinical trial in the 30 days previous the study start.

Sponsors & Collaborators

• Galderma Brasil Ltda.: lead

Study Sites (1)

Clínica Hexsel de Dermatologia

Porto Alegre, Rio Grande do Sul, 90550-141, Brazil

RECRUITING

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Carolina Siega

CONTACT

5551998900275; carolina.siega@galderma.com

Cristhine Kamamoto

CONTACT

5511933157523; cristhine.kamamoto@galderma.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 11, 2023
• Study Start: August 23, 2023
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: October 30, 2023

Record last verified: 2023-10

Locations

BR (1)