Flaccidity, Muscle Clinical Trial
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.
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.
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.
;