Efficacy and Safety of Poly-L-lactic Acid (Sculptra)

Galderma

Status: Completed

Conditions: Flaccidity, Muscle

Treatments: Device: Poly-L-lactic acid - Sculptra

Study type: Interventional

Funder types: Industry

Identifiers

NCT03225066

BR.16.001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: Female

Ages: 35 to 60 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Poly-L-Lactic Acid - Sculptra

Experimental group

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.

Treatment:

Device: Poly-L-lactic acid - Sculptra