Sculptra for Décolletage Crepiness and Wrinkling
April 16, 2018 updated by: David J. Goldberg, MD, Skin Laser & Surgery Specialists
The purpose of this study is to evaluate the safety and efficacy of Sculptra as a volume agent to improve décolletage crepiness and wrinkling.
Study Overview
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in décolletage crepiness and wrinkling in treatment area as measured by 5 point décolletage wrinkle scale
Time Frame: Screening, Treatment 1, Treatment 2, Treatment 3, 1 Month Follow up, 3 Month Follow up and 6 Month Follow up
|
Screening, Treatment 1, Treatment 2, Treatment 3, 1 Month Follow up, 3 Month Follow up and 6 Month Follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 9, 2015
Primary Completion (ACTUAL)
December 13, 2016
Study Completion (ACTUAL)
December 13, 2016
Study Registration Dates
First Submitted
May 26, 2016
First Submitted That Met QC Criteria
April 16, 2018
First Posted (ACTUAL)
April 26, 2018
Study Record Updates
Last Update Posted (ACTUAL)
April 26, 2018
Last Update Submitted That Met QC Criteria
April 16, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- SCULPTDEC01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.