Sculptra for Décolletage Crepiness and Wrinkling

Skin Laser & Surgery Specialists

Status: Completed

Conditions: Décolletage

Treatments: Other: Sculpta

Study type: Interventional

Funder types: Other

Identifiers

NCT03508973

SCULPTDEC01

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: Female

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Sculptra

Experimental group

Description:

Sculptra, an injectable implant containing microparticles of ply-L-lactic acid, carboxymethylcellulose, non-pyrogenic mannitol and sterile water, will be injected into the decolletage.

Treatment:

Other: Sculpta