Efficacy and Safety of Poly-L-lactic Acid

Galderma Brasil Ltda.70 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Flaccidity, Muscle

Interventions

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

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (4)

Centro Brasileiro de Estudos em Dermatologia

Porto Alegre, Rio Grande do Sul, Brazil

Fundação do ABC

São Paulo, São Paulo, Brazil

Hospital Israelita Albert Einstin

São Paulo, São Paulo, Brazil

Universidade Federal de São Paulo - UNIFESP - UNICCO

São Paulo, Brazil

Outcomes

Primary Outcomes

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.

Time frame: 4 months after starting Side 1 treatment

Secondary Outcomes

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.

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.

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

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.

Data from ClinicalTrials.gov

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