Efficacy and Safety of Poly-L-lactic Acid (Sculptra)

March 27, 2018 updated by: Galderma Brasil Ltda.

A Prospective, Randomized, Multicenter, Self-controlled, Blinded Trial on the Efficacy and Safety of Poly-L-lactic Acid - SCULPTRA - for the Treatment of Corporal Skin Flaccidity.

This study aims to assess efficacy and safety of Sculptra in the treatment of skin flaccidity in selected areas - arms, anteromedial region, and gluteal regions. To assess the efficacy of Sculptra®, via adapted Global Aesthetic Improvement Scale -GAIS- score determined by blind evaluator, in the treatment of skin flaccidity on the anteromedial region of arm and gluteal region, 4 months after initiating the treatment, based on the assessment of the corporal side randomized to be the first to receive treatment . Considering as an alternative hypothesis of interest a 70% value of the subjects the treated side would have higher GAIS than the untreated side.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Ethical and General considerations regarding the study conduction: This study protocol will be reviewed and approved by appropriate IEC/IRB prior to the initiation of the study.

Clinical monitoring: Study conduction will be closely monitored by Galderma representatives, following GCP regulations, applicable standard operating procedures, guides and local regulations.

Data Management: Data may be audited by Galderma Quality Assurance Department and/or CRO prior to or after results of the first statistical analysis on the primary discretion.

Quality assurance, auditing and Inspection: The study will be carried out under the sponsorship of Galderma in accordance with all local and federal regulations, as well as ICH guidelines. Audits and inspections at the research site may be conducted by Galderma representatives or local authorities. All aspects in any study step can be audited by Galderma Quality Assurance / CRO and, as a result, a certificate stating this will be provided.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 04022-000
        • Universidade Federal de São Paulo - UNIFESP - UNICCO
    • RS
      • Porto Alegre, RS, Brazil, 90550141
        • Centro Brasileiro de Estudos em Dermatologia
    • SP
      • São Paulo, SP, Brazil, 09041-410
        • Fundacao do ABC
      • São Paulo, SP, Brazil
        • Hospital Israelita Albert Einstin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

31 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Female;
  2. Age between 35 and 60 years (including 60 years);
  3. Indication for treatment of bilateral skin flaccidity of at least one of two corporal areas candidate for treatment (arms [anteromedial region] or gluteal regions);
  4. Mild to moderate flaccidity in the area to be treated, according to investigator's assessment and in accordance with appropriated flaccidity scales for corporal region to be treated;
  5. Subjects who understood and signed the Informed Consent Form (ICF) when entering the study, before performing any investigational procedure

Exclusion Criteria:

  1. Prior use (<1 year) or planning to use any other aesthetic treatment in the corporal area of interest for study, such as radiofrequency, cryolipolysis;
  2. History of liposuction, plastic surgery and / or corrective plastic surgery in the area of the body of interest for the study (arms or gluteal region);
  3. History (<1year) of treatment with Sculptra in other corporal area, area without interest for study;
  4. History of Sculptra treatment in the area of the body of interest for the study (arms or gluteal region);
  5. Any type of comorbidity or clinical condition that, at investigator s discretion, could interfere with study assessments;
  6. Using or planning to initiate restrictive diets (at investigator s discretion);
  7. Using or planning to initiate use of supplements for weight loss;
  8. Diabetes mellitus type 1 or type 2;
  9. Autoimmune diseases, collagenosis, decompensated endocrine diseases or any disease that, at investigator's discretion, could interfere with study assessments;
  10. Using or have used within 3 months drugs such as corticosteroids, immunosuppressants or others collagen-production inhibitors;
  11. Initiated use of hormones or change in dose of hormonal replacement therapy within 3 months;
  12. Practices regularly or intend to practice during the study high-performance or impact physical activities, such as weight lifting, marathon, triathlon;
  13. Pregnant or breastfeeding, or wishes to get pregnant within the next 18 months, or refuses to use appropriate contraceptive method (in case of women of childbearing potential).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Poly-L-Lactic Acid - Sculptra
Each area will be treated with a dose contained in a vial of Sculptra®. For conducting the study, six vials of the product will be available per subject, and one vial will be used in each session with up to maximum a total volume of 16mL per treated area. It will be 3 session with interval of 1 month in total.
Device: Poly-L-lactic acid - Sculptra
Participants using Sculptra - Poly-L-lactic acid 3 sessions in the first side and 3 sessions on the second side

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assess the aesthetic effect through photographs via GAIS score determined by blind evaluator
Time Frame: 4 months after starting Side 1 treatment
To see the percentage of research subjects, to which the blind evaluator assigned a Global Aesthetic Improvement Scale score (GAIS) score higher to Side 1 than the corporal side which will be the second to receive treatment (Side 2), 4 months after starting Side 1 treatment.
4 months after starting Side 1 treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assess the frequency with which the blind evaluators identified correctly Side 1, 4 months after initiating treatment on Side 1 through photographs.
Time Frame: 4 months after starting Side 1 treatment
1. Percentage of evaluators identifying correctly the first treated side, 4 months after initiating treatment on Side 1.
4 months after starting Side 1 treatment
Assess efficacy of Sculptra in the treatment of skin flaccidity via GAIS score determined by the investigator.
Time Frame: 4, 6 and 12 months after starting side 1 treatment and 6 and 8 months after starting side 2

3.1. Mean GAIS score assigned by the investigator to Side 1, 4 months after initiating treatment.

3.2. Mean GAIS score assigned by the investigator to Side 1, 6 months after initiating treatment.

3.3. Mean GAIS score assigned by the investigator to Side 1, 12 months after initiating treatment.

3.4. Mean GAIS score assigned by the investigator to Side 2, 6 months after initiating treatment.

3.5. Mean GAIS score assigned by the investigator to Side 2, 8 months after initiating treatment.
4, 6 and 12 months after starting side 1 treatment and 6 and 8 months after starting side 2
To assess the aesthetic effect of Sculptra in the skin flaccidity treatment, treatment, via GAIS score determined by the research subject.
Time Frame: 4, 6 and 12 months after initiating side 1 as well as 6 and 8 months after initiating side 2 treatment

4.1. Mean GAIS score assigned by the research subject to Side1, 4 months after initiating treatment.

4.2. Mean GAIS score assigned by the female subject to Side1, 6 months after initiating treatment.

4.3. Mean GAIS score assigned by the female subject to Side1, 12 months after initiating treatment.

4.4. Mean GAIS score assigned by the female subject to Side2, 6 months after initiating treatment.

4.5. Mean GAIS score assigned by the female subject to Side2, 8 months after initiating treatment.
4, 6 and 12 months after initiating side 1 as well as 6 and 8 months after initiating side 2 treatment
To assess aesthetic effect of Sculptra on skin flaccidity via GAIS score determined by the investigator
Time Frame: 4 months after initiating side 1 treatment
Percentage of research subjects to which the investigator assigned a GAIS score to Side 1, 4 months after initiating treatment, indicating aesthetic improvement (GAIS score between 3 and 5) in relation to pre-treatment condition.
4 months after initiating side 1 treatment
Evaluate aesthetic effect of Sculptra on skin flaccidity by comparing Side1 to Side2 by the investigator.
Time Frame: 4 months after initiating Side 1 treatment
Percentage of research subjects to which the investigator determined that the treated side (Side1) is aesthetically better than the non-treated side, 4 months after initiating Side1 treatment.
4 months after initiating Side 1 treatment
Assess the aesthetic effect of Sculptra on skin flaccidity, by comparing S1 to S2 by the research subject.
Time Frame: 4 months after initiating side 1 treatment
Percentage of research subjects evaluating the treated side (Side1) as aesthetically better than the non-treated side (Side2), 4 months after initiating Side1 treatment.
4 months after initiating side 1 treatment
Assess the effect of Sculptra on dermal thickness, via high-frequency ultrasound.
Time Frame: 4, 6 and 12 months after initiating side 1 treatment as well as 2 and 8 months after initiating Side 2 treatment

8.1. Variation of Side1 dermal thickness between baseline visit and 4 months after initiating treatment.

8.2. Variation of Side1 dermal thickness between baseline visit and 6 months after initiating treatment.

8.3. Variation of Side1 dermal thickness between baseline visit and 12 months after initiating treatment.

8.4. Variation of Side2 dermal thickness between baseline visit and 2 months after initiating treatment.

8.5. Variation of Side2 dermal thickness between baseline visit and 8 months after initiating treatment.
4, 6 and 12 months after initiating side 1 treatment as well as 2 and 8 months after initiating Side 2 treatment
Assess the subject s discomfort with Sculptra application.
Time Frame: 1 year
Mean score of subject s discomfort with Sculptra application during treatment period.
1 year
Evaluate Sculptra effect on arm circumference, 4, and 12 months after initiating Side 1 treatment
Time Frame: 4 and 12 months after initiating side 1 treatment

10.1. Variation of Side1 arm circumference between baseline visit and 4 months after initiating treatment.

10.2. Variation of Side1 arm circumference between baseline visit and 12 months after initiating treatment.
4 and 12 months after initiating side 1 treatment
Assess investigator s satisfaction and perception of aesthetic result obtained with Sculptra.
Time Frame: 4, 6 and 12 months after initiating side 1 treatment as well as 6 and 8 months after initiating side 2 treatment

11.1.Descriptive statistics of the satisfaction questionnaire and aesthetic result perception, completed by the investigator 4 months after initiating Side1 treatment.

11.2. Descriptive statistics of the satisfaction questionnaire and aesthetic result perception, completed by the investigator 6 months after initiating Side1 treatment.

11.3. Descriptive statistics of the satisfaction questionnaire and aesthetic result perception, completed by the investigator 12 months after initiating Side1 treatment.

11.4. Descriptive statistics of the satisfaction questionnaire and aesthetic result perception, completed by the investigator 6 months after initiating Side2 treatment.

11.5. Descriptive statistics of the satisfaction questionnaire and aesthetic result perception, completed by the investigator 8 months after initiating Side2 treatment.
4, 6 and 12 months after initiating side 1 treatment as well as 6 and 8 months after initiating side 2 treatment
Assess subject s satisfaction and aesthetic result perception obtained with Sculptra
Time Frame: 4, 6 and 12 months after initiating Side 1 treatment, as well as 6 and 8 months after initiating Side2 treatment

12.1. Descriptive statistics of satisfaction questionnaire and aesthetic result perception, completed by the subject 4 months after initiating Side1 treatment.

12.2. Descriptive statistics of satisfaction questionnaire and aesthetic result perception, completed by the subject 6 months after initiating Side1 treatment.

12.3. Descriptive statistics of satisfaction questionnaire and aesthetic result perception, completed by the subject 12 months after initiating Side1 treatment.

12.4. Descriptive statistics of satisfaction questionnaire and aesthetic result perception, completed by the subject 6 months after initiating Side2 treatment.

12.5. Descriptive statistics of satisfaction questionnaire and aesthetic result perception, completed by the subject 8 months after initiating Side2 treatment.
4, 6 and 12 months after initiating Side 1 treatment, as well as 6 and 8 months after initiating Side2 treatment
Incidence, seriousness, severity and relationship of adverse events with the treatment with Sculptra
Time Frame: An average of 1 year

13.1. Incidence, seriousness, severity and relationship with management of adverse events reported during study period.

13.2. Incidence, seriousness, severity and relationship with management of adverse events of interest reported during study period.

13.3. Incidence of treatment discontinuations due to adverse events reported during study period
An average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Galderma Brasil Ltda.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Samira Yarak, Federal University of São Paulo
  • Principal Investigator: Marisa G Cunha, Fundacao do ABC
  • Principal Investigator: Doris M Hexsel, Centro Brasileiro de Estudos em Dermatologia
  • Principal Investigator: Alessandra Haddad, Hospital Israelita Albert Einstein

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 21, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 10, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 10, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BR.16.001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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