Flaccidity, MuscleSculptraNCT03225066
Efficacy and Safety of Poly-L-lactic Acid
A study testing Poly-L-lactic acid - Sculptra in people with Flaccidity, Muscle, run by Galderma Brasil Ltda. at 4 sites in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Flaccidity, Muscle
- What is being tested?
- Poly-L-lactic acid - Sculptra
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 4 sitesBrazil
- Study dates
- 21 Aug 2017to 10 Jan 2018
- Phase
- Interventional
- 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 35 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female;
- Age between 35 and 60 years (including 60 years);
- Indication for treatment of bilateral skin flaccidity of at least one of two corporal areas candidate for treatment (arms [anteromedial region] or gluteal regions);
- 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;
- Subjects who understood and signed the Informed Consent Form (ICF) when entering the study, before performing any investigational procedure
Who cannot join
- Prior use (<1 year) or planning to use any other aesthetic treatment in the corporal area of interest for study, such as radiofrequency, cryolipolysis;
- 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);
- History (<1year) of treatment with Sculptra in other corporal area, area without interest for study;
- History of Sculptra treatment in the area of the body of interest for the study (arms or gluteal region);
- Any type of comorbidity or clinical condition that, at investigator s discretion, could interfere with study assessments;
- Using or planning to initiate restrictive diets (at investigator s discretion);
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- Using or planning to initiate use of supplements for weight loss;
- Diabetes mellitus type 1 or type 2;
- Autoimmune diseases, collagenosis, decompensated endocrine diseases or any disease that, at investigator's discretion, could interfere with study assessments;
- Using or have used within 3 months drugs such as corticosteroids, immunosuppressants or others collagen-production inhibitors;
- Initiated use of hormones or change in dose of hormonal replacement therapy within 3 months;
- Practices regularly or intend to practice during the study high-performance or impact physical activities, such as weight lifting, marathon, triathlon;
- 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).
Trial locations and contacts
4 sites in 1 country.
Brazil4 sites
Centro Brasileiro de Estudos em Dermatologia
Porto Alegre, Rio Grande do Sul, 90550141
Fundação do ABC
São Paulo, São Paulo, 09041-410
Hospital Israelita Albert Einstin
São Paulo, São Paulo
Universidade Federal de São Paulo - UNIFESP - UNICCO
São Paulo, 04022-000
About this study
Official title: 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.
Read the 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.
- Conditions
- Flaccidity, Muscle
- Being tested
- Poly-L-lactic acid - Sculptra
- Medical subject headings
- Muscle Hypotonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poly-L-lactic acid - SculptraDevice
Participants using Sculptra - Poly-L-lactic acid 3 sessions in the first side and 3 sessions on the second side
| Study group | Role | What they receive |
|---|---|---|
| Poly-L-Lactic Acid - Sculptra | Experimental | 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. Receives: Device: Poly-L-lactic acid - Sculptra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the aesthetic effect through photographs via GAIS score determined by blind evaluator
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.
Measured: 4 months after starting Side 1 treatment
Secondary outcomes (12)
Assess the frequency with which the blind evaluators identified correctly Side 1, 4 months after initiating treatment on Side 1 through photographs.
- Percentage of evaluators identifying correctly the first treated side, 4 months after initiating treatment on Side 1.
Measured: 4 months after starting Side 1 treatment
Assess efficacy of Sculptra in the treatment of skin flaccidity via GAIS score determined by the investigator.
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.
Measured: 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.
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.
Measured: 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
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.
Measured: 4 months after initiating side 1 treatment
Evaluate aesthetic effect of Sculptra on skin flaccidity by comparing Side1 to Side2 by the investigator.
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.
Measured: 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.
Percentage of research subjects evaluating the treated side (Side1) as aesthetically better than the non-treated side (Side2), 4 months after initiating Side1 treatment.
Measured: 4 months after initiating side 1 treatment
Assess the effect of Sculptra on dermal thickness, via high-frequency ultrasound.
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.
Measured: 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.
Mean score of subject s discomfort with Sculptra application during treatment period.
Measured: 1 year
Evaluate Sculptra effect on arm circumference, 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.
Measured: 4 and 12 months after initiating side 1 treatment
Assess investigator s satisfaction and perception of aesthetic result obtained with Sculptra.
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.
Measured: 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
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.
Measured: 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
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
Measured: An average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start21 Aug 2017
- Primary completion10 Jan 2018
- Study completion10 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flaccidity, MuscleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study sample will be stratified to include 50% of subjects, who will receive Sculptra treatment on the antero-medial side of the arms and approximately 50% of subjects, who will receive Sculptra treatment in the gluteal area, in order to exploratory analyzes by subgroup. During the study, the subjects should come to the research site up to nine times: one for the screening/inclusion visit (SV), three treatment visits (TVs) for Side 1 (from 1 to 14 days after SV, and from 1 to 2 months after first session), three TVs for Side 2 (4, 5 and 6 months after the first S1 treatment session), one follow-up visit (FUV), 6 months after the first S2 treatment session) and a final visit (FV) (12 months after the first S1 session). After 4 months of the first treatment we will compare the results between the first treated side and non-treated side.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma Brasil Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samira Yarak, Principal investigator, Federal University of São PauloMarisa G Cunha, Principal investigator, Fundacao do ABCDoris M Hexsel, Principal investigator, Centro Brasileiro de Estudos em DermatologiaAlessandra Haddad, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225066
- Sponsor's protocol ID
- BR.16.001
- Acronym
- Sculptra
- Status last verified
- Aug 2017
- First submitted
- 19 Jul 2017
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03225066
- Acronym / sponsor ID
- Sculptra / BR.16.001
- Conditions
- Flaccidity, Muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Galderma Brasil Ltda.Industry (pharma, biotech, devices)
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 10 Jan 2018 (actual)
- Study completion
- 10 Jan 2018 (actual)
- First posted
- 21 Jul 2017 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study sample will be stratified to include 50% of subjects, who will receive Sculptra treatment on the antero-medial side of the arms and approximately 50% of subjects, who will receive Sculptra treatment in the gluteal area, in order to exploratory analyzes by subgroup. During the study, the subjects should come to the research site up to nine times: one for the screening/inclusion visit (SV), three treatment visits (TVs) for Side 1 (from 1 to 14 days after SV, and from 1 to 2 months after first session), three TVs for Side 2 (4, 5 and 6 months after the first S1 treatment session), one follow-up visit (FUV), 6 months after the first S2 treatment session) and a final visit (FV) (12 months after the first S1 session). After 4 months of the first treatment we will compare the results between the first treated side and non-treated side.
| Arm | Type | Receives |
|---|---|---|
| Poly-L-Lactic Acid - Sculptra | Experimental | Device: Poly-L-lactic acid - SculptraEach 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. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female;
- Age between 35 and 60 years (including 60 years);
- Indication for treatment of bilateral skin flaccidity of at least one of two corporal areas candidate for treatment (arms [anteromedial region] or gluteal regions);
- 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;
- Subjects who understood and signed the Informed Consent Form (ICF) when entering the study, before performing any investigational procedure
Key exclusion criteria (13 listed)
- Prior use (<1 year) or planning to use any other aesthetic treatment in the corporal area of interest for study, such as radiofrequency, cryolipolysis;
- 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);
- History (<1year) of treatment with Sculptra in other corporal area, area without interest for study;
- History of Sculptra treatment in the area of the body of interest for the study (arms or gluteal region);
- Any type of comorbidity or clinical condition that, at investigator s discretion, could interfere with study assessments;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Poly-L-lactic acid - SculptraParticipants using Sculptra - Poly-L-lactic acid 3 sessions in the first side and 3 sessions on the second side | Device | Poly-L-Lactic Acid - Sculptra |
Primary outcome
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.
12 secondary outcomes
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
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
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
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
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
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
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
Assess the subject s discomfort with Sculptra application.
Time frame: 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
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
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
Incidence, seriousness, severity and relationship of adverse events with the treatment with Sculptra
Time frame: An average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Individual participant dataSharing planned: No
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.
Samira Yarak principal investigator
Federal University of São Paulo
Marisa G Cunha principal investigator
Fundacao do ABC
Doris M Hexsel principal investigator
Centro Brasileiro de Estudos em Dermatologia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Poly-L-lactic acid - Sculptra in people with Flaccidity, Muscle, run by Galderma Brasil Ltda. at 4 sites 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 13 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: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the aesthetic effect through photographs via GAIS score determined by blind evaluator (time frame: 4 months after starting Side 1 treatment). 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 29 Mar 2018; AzTrials last refreshed its copy on 6 Nov 2026.