Skin LaxityNCT05940038
Retrospective Study of the Safety and Efficacy of PLLA for Skin Flaccidity in Labia Majora and/or Pubis Region
An observational study of Skin Laxity, run by Galderma Brasil Ltda. at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Aug 2023to Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Clínica Hexsel de Dermatologia
Porto Alegre, Rio Grande do Sul, 90550-141
Doris Hexsel, MD, 555132641234, doris@hexsel.com.br
Vitor Costa Fabris, MD, 555132641234, pesquisa@hexsel.com.br
About this study
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
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.
Read the 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
- Medical subject headings
- Cutis Laxa
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of AEs
Measured: Since first application up to 12 months follow up.
Number (%) of AEs related to the study product or injection procedure
Measured: Since first application up to 12 months follow up.
Number of AEs related (%) to the study product by intensity (if available)
Measured: Since first application up to 12 months follow up.
Number (%) of subjects having at least one AE
Measured: 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
Measured: Since first application up to 12 months follow up.
Number (%) of subjects who died
Measured: 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
Measured: 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
Measured: Since third application up to 12 months follow up since first application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start23 Aug 2023
- Primary completionOct 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LaxityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Galderma Brasil Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940038
- Sponsor's protocol ID
- BR.16.003
- Status last verified
- Oct 2023
- First submitted
- 3 Jul 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05940038
- Acronym / sponsor ID
- BR.16.003
- Conditions
- Skin Laxity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Galderma Brasil Ltda.Industry (pharma, biotech, devices)
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of AEs
Time frame: Since first application up to 12 months follow up.
Number (%) of AEs related to the study product or injection procedure
Time frame: Since first application up to 12 months follow up.
Number of AEs related (%) to the study product by intensity (if available)
Time frame: Since first application up to 12 months follow up.
Number (%) of subjects having at least one AE
Time frame: 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
Time frame: Since first application up to 12 months follow up.
Number (%) of subjects who died
Time frame: Since first application up to 12 months follow up.
Improvement of cutaneous flaccidity of the labia majora and/or pubis region
Time frame: Since third application up to 12 months follow up since first application.
Assessed by the percentage of total scores (n, %): hugely better, much better, or better according to Global Aesthetic Improvement Scale
Improvement of global aesthetic aspect of the labia majora and/or pubis region
Time frame: Since third application up to 12 months follow up since first application.
Assessed by the percentage of total scores (n, %): hugely better, much better, or better according to Global Aesthetic Improvement Scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Laxity, run by Galderma Brasil Ltda. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carolina Siega (5551998900275, carolina.siega@galderma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of AEs (time frame: Since first application up to 12 months follow up.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.