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

Skin Laxity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05940038
• Other study ID #: BR.16.003
• Status: Recruiting
• Start date: August 23, 2023
• Est. completion date: November 2023

Study information

• Verified date: October 2023
• Source: Galderma Brasil Ltda.
• Contact: Carolina Siega
• Phone: 5551998900275
• Email: carolina.siega[@]galderma.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: November 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cutis Laxa
• Skin Laxity

Locations

Country	Name	City	State
Brazil	Clínica Hexsel de Dermatologia	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Galderma Brasil Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Improvement of symptoms related to functional complaints of the labia majora and/or mons pubis region	Assessed by the total percentage (n, %) of reported outcomes as hugely better, much better, or better	Since third application up to 12 months follow up since first application.
Primary	Number of AEs		Since first application up to 12 months follow up.
Primary	Number (%) of AEs related to the study product or injection procedure		Since first application up to 12 months follow up.
Primary	Number of AEs related (%) to the study product by intensity (if available)		Since first application up to 12 months follow up.
Primary	Number (%) of subjects having at least one AE		Since first application up to 12 months follow up.
Primary	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.
Primary	Number (%) of subjects who died		Since first application up to 12 months follow up.
Primary	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.
Primary	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.