What side effects are associated with this type of intervention?

Common treatments for cellulite, such as topical creams, laser therapy, and injectable treatments, can have various side effects. Topical creams may cause skin irritation, redness, and allergic reactions. Laser therapy can lead to temporary swelling, redness, and bruising. Injectable treatments might result in pain at the injection site, swelling, bruising, and, in rare cases, infection. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment option.

What prior FDA approvals exist?

The FDA has approved several treatments for cellulite, including injectable collagenase clostridium histolyticum-aaes (Qwo), which enzymatically disrupts the fibrous septae contributing to cellulite. Another approved treatment is the use of laser and light-based devices, such as Cellulaze, which targets the structural causes under the skin. Additionally, topical treatments like retinol creams have been used to improve skin texture and appearance. These treatments aim to reduce the appearance of cellulite by addressing the underlying structural issues in the skin.

What other types of research exist?

Promising novel alternatives to CBL-514 for cellulite treatment in 2024 include: 1) Injectable collagenase clostridium histolyticum (CCH), which enzymatically breaks down collagen in fibrous septae contributing to cellulite. 2) Laser and radiofrequency devices that target subdermal layers to reduce fat and tighten skin. 3) Topical retinoids and peptides that improve skin texture and elasticity. 4) Acoustic wave therapy (AWT) that uses sound waves to improve microcirculation and reduce cellulite appearance.

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Unknown

CBL-514 Injections for Cellulite

Phase 2

Waitlist Available

Research Sponsored by Caliway Biopharmaceuticals Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks from the final treatment visit

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing CBL-514, a treatment given through skin injections, in people with a specific type of cellulite that may not respond to usual treatments. The goal is to see if these injections can safely and effectively reduce cellulite.

Who is the study for?

This trial is for women aged 18-64 with a certain level of cellulite, known as EFP (Stage 2), who have stable lifestyles and body weight requirements. They must not be on certain medications or have conditions that could affect the study's safety or results, like liver issues, cardiovascular diseases, or recent aesthetic procedures. Participants cannot be pregnant and must use contraception.

What is being tested?

The trial is testing CBL-514 injections to see if they are effective and safe in treating Stage 2 cellulite. It's an open-label study where all participants receive the treatment without being compared to a placebo or other treatments.

What are the potential side effects?

While specific side effects of CBL-514 aren't listed here, common injection-related side effects may include pain at the injection site, swelling, bruising, redness, itching and potential allergic reactions to ingredients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks from the final treatment visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks from the final treatment visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks from the final treatment visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluation of the score change of edematous fibrosclerotic panniculopathy (EFP) measured by cellulite severity scale from baseline following administration of at least 1 course of CBL-514.

Secondary study objectives

Evaluation of the response rate of EFP score change by Global Aesthetic Improvement Scale (GAIS) reported by the clinician and participant, respectively, following the administration of at least 1 course of CBL-514.

Evaluation of the total score change of edematous fibrosclerotic panniculopathy (EFP) measured by cellulite severity scale from baseline following administration of at least 1 course of CBL-514.

Percentage of participants' thighs that achieve at least 1-level severity improvement measured by cellulite severity scale from baseline following administration of 1 course of CBL-514.

+1 more

Other study objectives

Incidence of adverse events and treatment-emergent adverse events (TEAEs)

Incidence of adverse events and treatment-emergent adverse events (TEAEs) at the injection site(s)

Incidence of adverse events and treatment-emergent adverse events (TEAEs) related to the investigational product (IP)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CBL-514 up to 320mgExperimental Treatment1 Intervention

Participants will receive up to 320 mg per treatment session at intervals of approximately 4 weeks for up to a maximum of 2 treatments.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CBL-514 injection

2023

Completed Phase 2

~30

Do I qualify?Apply below to find out

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 cellulite include topical treatments, laser and radiofrequency therapy, and injectable treatments. Topical treatments often contain ingredients like caffeine or retinol, which aim to improve skin texture and reduce fat cells. Laser and radiofrequency therapies work by heating the skin and underlying tissues to stimulate collagen production and break down fat. Injectable treatments, such as CBL-514, typically involve substances that break down fat cells and improve skin elasticity. Understanding these mechanisms is crucial for patients as it helps them make informed decisions about which treatment may be most effective for their specific condition and expectations.

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