Ignite Creation Date:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2026-02-18 @ 1:32 AM
Study NCT ID:
NCT03225066
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2017-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Poly-L-lactic Acid
Sponsor:
Galderma Brasil Ltda.
Organization:
Study Overview
Official Title:
A Prospective, Randomized, Multicenter, Self-controlled, Blinded Trial on the Efficacy and Safety of Poly-L-lactic Acid - SCULPTRA - for the Treatment of Corporal Skin Flaccidity.
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Sculptra
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: