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Efficacy and Safety of Poly-L-lactic Acid

NCT03225066 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2018-03-29

No results posted yet for this study

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

Interventions

DEVICE

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

Sponsors & Collaborators

  • Galderma Brasil Ltda.

    lead INDUSTRY

Principal Investigators

  • Samira Yarak · Federal University of São Paulo

  • Marisa G Cunha · Fundacao do ABC

  • Doris M Hexsel · Centro Brasileiro de Estudos em Dermatologia

  • Alessandra Haddad · Hospital Israelita Albert Einstein

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-21
Primary Completion
2018-01-10
Completion
2018-01-10

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03225066 on ClinicalTrials.gov