Efficacy and Safety of Poly-L-lactic Acid

Not Applicable

Completed

• Conditions: Flaccidity, Muscle
• Interventions: Device: Poly-L-lactic acid - Sculptra

• Registration Number: NCT03225066
• Lead Sponsor: Galderma Brasil Ltda.

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.

Study Timeline

• Study First Submitted: 2017-07-19
• Study First Submitted QC: 2017-07-19
• Study First Posted: 2017-07-21
• Status Verified: 2017-08
• Study Start: 2017-08-21
• Primary Completion: 2018-01-10
• Study Completion: 2018-01-10
• Last Update Submitted: 2018-03-27
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Poly-L-Lactic Acid - Sculptra	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.

Primary Outcome Measures

Name	Time	Method
Assess the aesthetic effect through photographs via GAIS score determined by blind evaluator	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.

Secondary Outcome Measures

Name	Time	Method
Assess the frequency with which the blind evaluators identified correctly Side 1, 4 months after initiating treatment on Side 1 through photographs.	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.
To assess aesthetic effect of Sculptra on skin flaccidity via GAIS score determined by the investigator	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.
Assess the effect of Sculptra on dermal thickness, via high-frequency ultrasound.	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.
Incidence, seriousness, severity and relationship of adverse events with the treatment with Sculptra	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
Assess efficacy of Sculptra in the treatment of skin flaccidity via GAIS score determined by the investigator.	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.
To assess the aesthetic effect of Sculptra in the skin flaccidity treatment, treatment, via GAIS score determined by the research subject.	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.
Assess the aesthetic effect of Sculptra on skin flaccidity, by comparing S1 to S2 by the research subject.	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.
Assess the subject s discomfort with Sculptra application.	1 year	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	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.	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.
Assess subject s satisfaction and aesthetic result perception obtained with Sculptra	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.
Evaluate aesthetic effect of Sculptra on skin flaccidity by comparing Side1 to Side2 by the investigator.	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.

Trial Locations

Locations (4)

Universidade Federal de São Paulo - UNIFESP - UNICCO; 🇧🇷 São Paulo, Brazil

Centro Brasileiro de Estudos em Dermatologia; 🇧🇷 Porto Alegre, RS, Brazil

Hospital Israelita Albert Einstin; 🇧🇷 São Paulo, SP, Brazil

Fundação do ABC; 🇧🇷 São Paulo, SP, Brazil