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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6
Awards & highlights
Study Summary
This trial will look at the safety and effectiveness of using two different volumes of poly-l-lactic acid to correct wrinkles on the chest.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Percentage of responders
Trial Design
2Treatment groups
Active Control
Group I: 8mlActive Control1 Intervention
Device: Sculptra current label dilution for treatment of wrinkles in the decolletage area
Group II: 17mlActive Control1 Intervention
Experimental: PLLA new dilution volume for treatment of wrinkles in the decolletage area
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Who is running the clinical trial?
Galderma R&DLead Sponsor
298 Previous Clinical Trials
60,288 Total Patients Enrolled
Study DirectorStudy DirectorGalderma R&D
1,207 Previous Clinical Trials
489,650 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had any cosmetic procedures done on your chest area before the start of the trial.You are allergic or have had a bad reaction to Sculptra in the past.You have had any permanent surgical implant or plastic surgery in the area that will be treated in the clinical trial.You are looking for treatment for the area between your neck and chest.
Research Study Groups:
This trial has the following groups:- Group 1: 8ml
- Group 2: 17ml
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment still available for this clinical research endeavor?
"Confirmed, this medicinal experiment is currently recruiting volunteers. It was initially published on August 31st 2022 and the most recent changes were made on September 13th 2022."
Answered by AI
How many participants are currently undergoing treatment in this research project?
"Affirmative. Clinicaltrials.gov lists this medical study as actively recruiting, with the initial posting date of August 31st 2022 and last update on September 13th 2022. The trial aims to enroll 30 participants across two clinical sites."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
South Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Recent research and studies
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