A Confirmatory Study for Evaluation of the Treatment by the Celluma3 of Periorbital Wrinkles

Wrinkled Structure Clinical Trial

Official title: A Confirmatory Study for Evaluation of the Treatment by the Celluma3 of Periorbital Wrinkles

Status Completed

Clinical Trial Summary

The primary objective of this study is to confirm the safe and effective use of the Celluma3 for the reduction in the appearance of periorbital wrinkles.

Clinical Trial Description

This clinical study is an open label investigation into the use of the Celluma3 for the effective treatment of periorbital wrinkles.

Test subjects will visit a study center for thirty minute treatments, three times per week, for a period of four weeks, and a twelve week post-treatment follow up after the final treatment. Test subjects will have photos taken at the start, at the end of the four week treatment, and at the final twelve week post-treatment follow up visit.

One of the three Clinical Investigators, will act as the Principal Investigator and all three Clinical Investigators will evaluate the test subjects for inclusion and final results. The Clinical Research Associate (CRA) will monitor the study for conformance to the test protocol.

There will be seven estheticians participating in the study and there will be fifty test subjects recruited. ;

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Wrinkled Structure

• NCT number: NCT02543970
• Study type: Observational
• Source: BioPhotas
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Completion date: August 2015