Décolletage
Conditions
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.
Interventions
OTHERSculpta
Sponsors
Skin Laser & Surgery Specialists
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed