Efficacy and Safety of Poly-L-lactic Acid

NCT ID: NCT03225066

Last Updated: 2018-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-21
• Study Completion Date: 2018-01-10

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.

Conditions

Flaccidity, Muscle

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Poly-L-lactic acid - Sculptra

Intervention Type: DEVICE

Participants using Sculptra - Poly-L-lactic acid 3 sessions in the first side and 3 sessions on the second side

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Galderma Brasil Ltda.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samira Yarak

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Marisa G Cunha

Role: PRINCIPAL_INVESTIGATOR

Fundacao do ABC

Doris M Hexsel

Role: PRINCIPAL_INVESTIGATOR

Centro Brasileiro de Estudos em Dermatologia

Alessandra Haddad

Role: PRINCIPAL_INVESTIGATOR

Hospital Israelita Albert Einstein

Locations

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

Countries

Brazil

Other Identifiers

BR.16.001

Identifier Type: -

Identifier Source: org_study_id