Efficacy and Safety of Poly-L-lactic Acid

NCT03225066 | Completed DMC

• 1 other identifier: BR.16.001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 4

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.

Conditions

Flaccidity, Muscle

Outcome Measures

Primary Outcomes (1)

• 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.

  4 months after starting Side 1 treatment

Secondary Outcomes (12)

• 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

• 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

• 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

• To assess aesthetic effect of Sculptra on skin flaccidity via GAIS score determined by the investigator

  4 months after initiating side 1 treatment

• Evaluate aesthetic effect of Sculptra on skin flaccidity by comparing Side1 to Side2 by the investigator.

  4 months after initiating Side 1 treatment

Study Arms (1)

Poly-L-Lactic Acid - Sculptra

EXPERIMENTAL

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.

Device: Poly-L-lactic acid - Sculptra

Interventions

Poly-L-lactic acid - Sculptra DEVICE

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

Poly-L-Lactic Acid - Sculptra

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Galderma Brasil Ltda.: lead

Study Sites (4)

Centro Brasileiro de Estudos em Dermatologia

Porto Alegre, Rio Grande do Sul, 90550141, Brazil

Location

Fundação do ABC

São Paulo, São Paulo, 09041-410, Brazil

Location

Hospital Israelita Albert Einstin

São Paulo, São Paulo, Brazil

Location

Universidade Federal de São Paulo - UNIFESP - UNICCO

São Paulo, 04022-000, Brazil

Location

MeSH Terms

Conditions

Muscle Hypotonia

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Samira Yarak

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

• Marisa G Cunha

  Fundacao do ABC

  PRINCIPAL INVESTIGATOR

• Doris M Hexsel

  Centro Brasileiro de Estudos em Dermatologia

  PRINCIPAL INVESTIGATOR

• Alessandra Haddad

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: July 21, 2017
• Study Start: August 21, 2017
• Primary Completion: January 10, 2018
• Study Completion: January 10, 2018
• Last Updated: March 29, 2018

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (4)