Sculptra for Décolletage Crepiness and Wrinkling

Not Applicable

Completed

• Conditions: Décolletage

• Registration Number: NCT03508973
• Lead Sponsor: Skin Laser & Surgery Specialists

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of Sculptra as a volume agent to improve décolletage crepiness and wrinkling.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-09
• Study First Submitted: 2016-05-26
• Primary Completion: 2016-12-13
• Study Completion: 2016-12-13
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-16
• Last Update Submitted: 2018-04-16
• Study First Posted: 2018-04-26
• Last Update Posted: 2018-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

• Female volunteer
• Aged from 40-70 years on the day of screening
• No known medical conditions that may interfere with study participation
• Moderate to severe crepiness and wrinkling of the décolletage
• Willingness to not use any products on their décolleté for the duration of the study
• Read, understand, and sign informed consent forms
• Willingness to sign photography release form
• Willing and able to comply with all follow-up requirements
• Willingness to undergo a series of three Sculptra injections, 2-3 months apart, in their décolletage

Exclusion Criteria

• Any significant skin disease at treatment area
• Any medical condition which could interfere with the treatment
• Inability or unwillingness to follow the treatment schedule
• Inability or unwillingness to sign the informed consent
• History of poor wound healing
• History of keloid formation
• History of HIV, hepatitis, immuno-compromised
• Pregnant or lactating
• Previous use of deep chemical peels on the treatment area
• Previous injections of Sculptra in the décolletage
• Known hypersensitivity to Sculptra or any of its ingredients
• Previous laser or light based treatments to the treatment area 6 months prior to the screening visit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in décolletage crepiness and wrinkling in treatment area as measured by 5 point décolletage wrinkle scale	Screening, Treatment 1, Treatment 2, Treatment 3, 1 Month Follow up, 3 Month Follow up and 6 Month Follow up