Sculptra for Décolletage Crepiness and Wrinkling
Not Applicable
Completed
- Conditions
- Décolletage
- Interventions
- Other: Sculpta
- 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
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
- Arm && Interventions
Group Intervention Description Sculptra Sculpta Sculptra, an injectable implant containing microparticles of ply-L-lactic acid, carboxymethylcellulose, non-pyrogenic mannitol and sterile water, will be injected into the decolletage.
- 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
- Secondary Outcome Measures
Name Time Method