What side effects are associated with this type of intervention?

Common treatments for loose skin that stimulate collagen production and restore volume, such as Injectable Poly-L-Lactic Acid (PLLA), hyaluronic acid fillers, and calcium hydroxylapatite, can have several side effects. These may include injection site reactions like redness, swelling, pain, and bruising. Late-onset side effects for PLLA can include the formation of subcutaneous nodules and granulomas. Hyaluronic acid fillers may cause similar injection site reactions and, in rare cases, lead to the Tyndall effect, where the skin takes on a bluish tint. Calcium hydroxylapatite can also cause similar local reactions and, in some cases, lead to the formation of nodules or granulomas.

What prior FDA approvals exist?

The FDA has approved several treatments for loose skin that work by stimulating collagen production and restoring volume. One notable example is Sculptra® Aesthetic, which contains injectable poly-L-lactic acid (PLLA). This treatment is specifically designed to address volume loss and improve skin laxity by stimulating the body's natural collagen production. Other FDA-approved injectable fillers that serve similar purposes include hyaluronic acid-based products like Juvéderm and Restylane, which also help to restore volume and smooth out wrinkles by attracting and retaining moisture in the skin.

What other types of research exist?

Promising alternatives to Injectable Poly-L-Lactic Acid (PLLA) for treating loose skin include: <ol> <li>Hyaluronic Acid Fillers (e.g., Juvéderm, Restylane) - Known for their ability to restore volume and improve skin texture.</li> <li></li> </ol> Calcium Hydroxylapatite (e.g., Radiesse) - Stimulates collagen production and provides long-lasting results. 3. Cross-Linked Hyaluronan - Used for its safety and effectiveness in soft tissue augmentation. 4. Liquid Silicone - Although controversial, it has shown long-term efficacy in specific cases. These alternatives offer various benefits and should be discussed with a healthcare provider to determine the best option based on individual needs and medical history.

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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 six 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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 3, 6, and 9 month follow-up visits for reporting.

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 more

Secondary study objectives

Collagen Analysis

Elastin Analysis

Evaluation of Side Effects

+3 more

Trial 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

0 / 12Eligibility criteria met

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.