Sculptra for Décolletage Crepiness and Wrinkling

NCT03508973 | Completed

• 1 other identifier: SCULPTDEC01
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Sculptra

EXPERIMENTAL

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

Other: Sculpta

Interventions

Sculpta OTHER

Sculptra

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Skin Laser & Surgery Specialists: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: David J. Goldberg, MD, JD

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: April 26, 2018
• Study Start: November 9, 2015
• Primary Completion: December 13, 2016
• Study Completion: December 13, 2016
• Last Updated: April 26, 2018

Record last verified: 2018-04