Back to resultsEfficacy and Safety of Poly-L-lactic Acid (Sculptra)
Primary Purpose
Flaccidity, Muscle
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Poly-L-lactic acid - Sculptra
Sponsored by
About this trial
This is an interventional treatment trial for Flaccidity, Muscle
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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);
- 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).
Sites / Locations
- Centro Brasileiro de Estudos em Dermatologia
- Fundação do ABC
- Hospital Israelita Albert Einstin
- Universidade Federal de São Paulo - UNIFESP - UNICCO
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Poly-L-Lactic Acid - Sculptra
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Assess the frequency with which the blind evaluators identified correctly Side 1, 4 months after initiating treatment on Side 1 through photographs.
1. Percentage of evaluators identifying correctly the first treated side, 4 months after initiating treatment on Side 1.
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.
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.
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.
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.
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.
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.
Assess the subject s discomfort with Sculptra application.
Mean score of subject s discomfort with Sculptra application during treatment period.
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.
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.
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03225066
Brief Title
Efficacy and Safety of Poly-L-lactic Acid
Acronym
Sculptra
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 21, 2017 (Actual)
Primary Completion Date
January 10, 2018 (Actual)
Study Completion Date
January 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma Brasil Ltda.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flaccidity, Muscle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Masking Description
P.S. To assess the efficacy of Sculptra, via adapted Global Aesthetic Improvement Scale score determined by blind evaluator (Outcomes assessor ), 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. I input as NO MASKING because appears ERROR when I included Outcomes assessor.
Allocation
N/A
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Poly-L-Lactic Acid - Sculptra
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Poly-L-lactic acid - Sculptra
Intervention Description
Participants using Sculptra - Poly-L-lactic acid 3 sessions in the first side and 3 sessions on the second side
Primary Outcome Measure Information:
Title
Assess the aesthetic effect through photographs via GAIS score determined by blind evaluator
Description
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.
Time Frame
4 months after starting Side 1 treatment
Secondary Outcome Measure Information:
Title
Assess the frequency with which the blind evaluators identified correctly Side 1, 4 months after initiating treatment on Side 1 through photographs.
Description
1. Percentage of evaluators identifying correctly the first treated side, 4 months after initiating treatment on Side 1.
Time Frame
4 months after starting Side 1 treatment
Title
Assess efficacy of Sculptra in the treatment of skin flaccidity via GAIS score determined by the investigator.
Description
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.
Time Frame
4, 6 and 12 months after starting side 1 treatment and 6 and 8 months after starting side 2
Title
To assess the aesthetic effect of Sculptra in the skin flaccidity treatment, treatment, via GAIS score determined by the research subject.
Description
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.
Time Frame
4, 6 and 12 months after initiating side 1 as well as 6 and 8 months after initiating side 2 treatment
Title
To assess aesthetic effect of Sculptra on skin flaccidity via GAIS score determined by the investigator
Description
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.
Time Frame
4 months after initiating side 1 treatment
Title
Evaluate aesthetic effect of Sculptra on skin flaccidity by comparing Side1 to Side2 by the investigator.
Description
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.
Time Frame
4 months after initiating Side 1 treatment
Title
Assess the aesthetic effect of Sculptra on skin flaccidity, by comparing S1 to S2 by the research subject.
Description
Percentage of research subjects evaluating the treated side (Side1) as aesthetically better than the non-treated side (Side2), 4 months after initiating Side1 treatment.
Time Frame
4 months after initiating side 1 treatment
Title
Assess the effect of Sculptra on dermal thickness, via high-frequency ultrasound.
Description
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.
Time Frame
4, 6 and 12 months after initiating side 1 treatment as well as 2 and 8 months after initiating Side 2 treatment
Title
Assess the subject s discomfort with Sculptra application.
Description
Mean score of subject s discomfort with Sculptra application during treatment period.
Time Frame
1 year
Title
Evaluate Sculptra effect on arm circumference, 4, and 12 months after initiating Side 1 treatment
Description
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.
Time Frame
4 and 12 months after initiating side 1 treatment
Title
Assess investigator s satisfaction and perception of aesthetic result obtained with Sculptra.
Description
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.
Time Frame
4, 6 and 12 months after initiating side 1 treatment as well as 6 and 8 months after initiating side 2 treatment
Title
Assess subject s satisfaction and aesthetic result perception obtained with Sculptra
Description
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.
Time Frame
4, 6 and 12 months after initiating Side 1 treatment, as well as 6 and 8 months after initiating Side2 treatment
Title
Incidence, seriousness, severity and relationship of adverse events with the treatment with Sculptra
Description
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
Time Frame
An average of 1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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);
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samira Yarak
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marisa G Cunha
Organizational Affiliation
Fundacao do ABC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Doris M Hexsel
Organizational Affiliation
Centro Brasileiro de Estudos em Dermatologia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alessandra Haddad
Organizational Affiliation
Hospital Israelita Albert Einstein
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Brasileiro de Estudos em Dermatologia
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90550141
Country
Brazil
Facility Name
Fundação do ABC
City
São Paulo
State/Province
SP
ZIP/Postal Code
09041-410
Country
Brazil
Facility Name
Hospital Israelita Albert Einstin
City
São Paulo
State/Province
SP
Country
Brazil
Facility Name
Universidade Federal de São Paulo - UNIFESP - UNICCO
City
São Paulo
ZIP/Postal Code
04022-000
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy and Safety of Poly-L-lactic Acid
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