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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
Must not have
Subjects with scarring in the treatment areas
History of thrombosis, post-thrombosis syndrome, or any vascular disorder of the bilateral lower extremities
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to three months post final treatment
Summary
This trial is testing Sculptra® Aesthetic injections to see if they can safely and effectively increase hip volume by stimulating natural tissue growth. It targets people who want to enhance their hip appearance. The treatment works by encouraging the body to produce more collagen and fat tissue in the injected area. Sculptra, containing poly-L-lactic acid (PLLA), has been used successfully for facial volume restoration and is known for its long-lasting effects and safety profile.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have scarring in the areas that need treatment.
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I have had blood clots or vascular issues in both of my legs.
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I have not had liposuction on my hips, flanks, thighs, or buttocks in the last year or during the study.
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I am not planning any cosmetic procedures in the treatment areas during the study.
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I have an active infection in the area that would be treated.
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I have a history of bleeding or blood clotting disorders.
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I am not pregnant, planning to become pregnant, or breastfeeding during the study.
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I have wounds in the treatment area that have not fully healed.
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I am taking immunosuppressants or have an autoimmune condition.
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I haven't had cosmetic procedures or surgeries in the last year.
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I do not have any skin conditions that could affect the study's evaluation.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Histological Analysis
Identification of correct Treatment Area (Right vs Left Hip)
Physician Global Aesthetic Improvement Scale
+1 moreSecondary study objectives
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for loose skin, such as Injectable Poly-L-Lactic Acid (PLLA), work primarily by stimulating collagen production and restoring volume. PLLA acts as a scaffold that encourages the body's natural collagen synthesis, leading to gradual skin tightening and improved skin texture over time.
This is crucial for patients with loose skin as it not only enhances skin firmness but also provides a more natural and long-lasting improvement compared to temporary fillers. By promoting endogenous collagen formation, these treatments offer a sustainable solution to skin laxity, addressing both the aesthetic and structural aspects of loose skin.
Safety in immediate reconstitution of poly-l-lactic acid for facial biostimulation treatment.
Safety in immediate reconstitution of poly-l-lactic acid for facial biostimulation treatment.
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Who is running the clinical trial?
Goldman, Butterwick, Fitzpatrick and GroffLead Sponsor
29 Previous Clinical Trials
610 Total Patients Enrolled
Galderma R&DIndustry Sponsor
300 Previous Clinical Trials
60,443 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.
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