Sculptra for Décolletage Crepiness and Wrinkling

NCT ID: NCT03508973

Last Updated: 2018-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-09
• Study Completion Date: 2016-12-13

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.

Conditions

Décolletage

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sculptra

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

Group Type: EXPERIMENTAL

Sculpta

Intervention Type: OTHER

Interventions

Sculpta

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Skin Laser & Surgery Specialists

OTHER

Sponsor Role: lead

Responsible Party

David J. Goldberg, MD

David J. Goldberg, MD, JD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

SCULPTDEC01

Identifier Type: -

Identifier Source: org_study_id