Your session is about to expire
← Back to Search
Filler
Poly-L-Lactic Acid for Loose Skin
N/A
Waitlist Available
Research Sponsored by Goldman, Butterwick, Fitzpatrick and Groff
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult females aged 30 to 60 years
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to six months post final treatment
Awards & highlights
Study Summary
This trial assesses the safety, efficacy and subject satisfaction of Sculptra Aesthetic, a injectable poly-lactic acid, for volumization of the hip dell.
Who is the study for?
This trial is for adult women aged 30 to 60 with moderate to severe hip dell volume deficit. Participants must be in good health, have stable body weight for the last six months, and agree to maintain their usual routines. They should not have had certain treatments or conditions that affect the hips and skin, and must use effective birth control if of childbearing potential.Check my eligibility
What is being tested?
The trial tests injectable poly-L-lactic acid (PLLA), also known as Sculptra Aesthetic, against a saline solution to see how well it works for adding volume to the hip area. It will measure safety, effectiveness, and patient satisfaction with the treatment.See study design
What are the potential side effects?
Possible side effects may include reactions at the injection site such as redness, swelling or bruising; lumps under the skin; itching; discomfort; rare allergic reactions; or other local complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged between 30 and 60.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1, 3, 6, and 9 month follow-up visits
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 3, 6, and 9 month follow-up visits
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Histological Analysis
Identification of correct Treatment Area (Right vs Left Hip)
Physician Global Aesthetic Improvement Scale
+1 moreSecondary outcome measures
Collagen Analysis
Elastin Analysis
Evaluation of Side Effects
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: injectable poly-L-lactic acidExperimental Treatment1 Intervention
One side of the subject's hips will be treated with injectable poly-L-lactic acid (PLLA, Sculptra® Aesthetic; Galderma Laboratories; Fort Worth, TX).
Group II: Normal SalinePlacebo Group1 Intervention
One side of the subject's hips will be treated with injectable normal saline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
injectable poly-L-lactic acid
2011
Completed Phase 4
~20
Find a Location
Who is running the clinical trial?
Goldman, Butterwick, Fitzpatrick and GroffLead Sponsor
28 Previous Clinical Trials
570 Total Patients Enrolled
Galderma R&DIndustry Sponsor
298 Previous Clinical Trials
60,310 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am using or willing to use an approved method of birth control.I am a woman aged between 30 and 60.I agree to keep my sun exposure, diet, and exercise habits the same during the study.I have not used creams or home therapies for hip area plumping in the last 4 weeks.I have scarring in the areas that need treatment.You have a significant decrease in the volume of your hip bone, as determined by the researchers.You have received treatment for hip volume deficit in the past year.I have not had massage therapy in the last 3 months.I have had blood clots or vascular issues in both of my legs.I have not had liposuction on my hips, flanks, thighs, or buttocks in the last year or during the study.I am not planning any cosmetic procedures in the treatment areas during the study.You have tattoos or permanent implants where the treatment will be given.I haven't used spray tan or sunless tanners on the treatment area in the last 4 weeks.You have a history of developing large or raised scars.I have an active infection in the area that would be treated.I have a history of bleeding or blood clotting disorders.I am not pregnant, planning to become pregnant, or breastfeeding during the study.I have wounds in the treatment area that have not fully healed.I am taking immunosuppressants or have an autoimmune condition.I haven't had cosmetic procedures or surgeries in the last year.I agree not to tan or use sunless tanner during the study.You need to have a negative pregnancy test before joining the study (if it applies to you).I am not able to become pregnant due to menopause, surgery, or sterilization.I am willing to follow the study's treatment plan and complete the study.I do not have any skin conditions that could affect the study's evaluation.
Research Study Groups:
This trial has the following groups:- Group 1: injectable poly-L-lactic acid
- Group 2: Normal Saline
Awards:
This trial has 0 awards, including: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 recruitment still open for this investigation?
"Clinicialtrials.gov reports that this research is no longer recruiting participants, as the study was initially posted on March 4th 2022 and last updated 25 February 2022. However, there are 14 other trials presently enrolling patients at the moment."
Answered by AI
What end point are investigators hoping to achieve with this research?
"The primary purpose of this medical study, which will have a 9-month follow up visit, is to ascertain whether treatment should be administered to the right or left hip. Secondary goals include elastin analysis through histology and assessing adverse events during treatment as well as measuring skin thickness with ultrasound imaging."
Answered by AI
Am I eligible to take part in this medical experiment?
"This trial will enroll 20 adults between the ages of 30-60 with cutis laxa. To qualify, they must be generally healthy and have had a stable body weight for at least 6 months prior to enrollment. Females of childbearing potential need to use birth control throughout the duration of the study while male participants should agree not to donate sperm in this period too. Besides these criteria, subjects are also required to stick to their usual sun exposure patterns, diet, and exercise routines during participation as well as give informed consent before proceeding with any tests or procedures."
Answered by AI
Is this research recruiting geriatric participants?
"This research project is seeking participants who are aged between 30 and 60 years old."
Answered by AI
Who else is applying?
What site did they apply to?
West Dermatology Research Center/Cosmetic Laser Dermatology
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger