AVELI for Cellulite

(AVE001 Trial)

Recruiting at 2 trial locations

Overseen By Alfredo Hoyos, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Total Definer Research Group

Must not be taking: Aspirin, Anticoagulants

Disqualifiers: Pregnancy, Obesity, Connective tissue disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: Immediate procedure

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called AVELI to determine its safety and effectiveness in reducing cellulite and fibrotic tissue (scar-like tissue) for individuals undergoing High-Definition Liposculpture. The researchers aim to discover if AVELI can improve the appearance and texture of skin by reducing visible cellulite and fibrosis without causing serious side effects. The trial includes participants with noticeable cellulite or fibrosis, particularly those who have undergone previous liposuction. Researchers will track participants' progress through photos and 3D imaging over time. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could enhance cosmetic procedures.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use aspirin or any anticoagulant within 14 days and 5 days before surgery, respectively. It's best to discuss your medications with the trial team.

What prior data suggests that AVELI is safe for reducing cellulite and fibrotic tissue?

Research has shown that AVELI is generally safe and well-tolerated by patients. In earlier studies, side effects were mild and mostly resolved by the 12-month check-up. Some patients experienced minor issues like fluid retention, but these were not serious. Overall, AVELI has proven safe for reducing cellulite, particularly on the buttocks and thighs. Clinical data supports this treatment, confirming its safety for use in people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about AVELI for cellulite because it offers a unique approach compared to existing treatments like topical creams and laser therapies. Unlike these standard options, which often focus on surface-level improvements, AVELI targets the root cause by precisely releasing the fibrous bands beneath the skin that cause dimpling. This innovative mechanism could potentially offer more lasting results and smoother skin. Additionally, AVELI is being evaluated for its effectiveness on both cellulite and fibrosis, which could broaden its application and effectiveness beyond what current treatments offer.

What evidence suggests that AVELI is effective for reducing cellulite and fibrotic tissue?

Research has shown that AVELI effectively reduces cellulite. In a major study, participants noticed significant improvement in their cellulite, with changes lasting over a year. Most participants were satisfied with the results, with 80% happy after three months and 93% pleased after one year. AVELI works well for mild to moderate cellulite. In this trial, participants in the Cellulite Group (CG) will receive AVELI treatment specifically for cellulite. Meanwhile, those in the Fibrosis Group (FG) and the Fibrosis and Cellulite Group (FCG) will receive AVELI treatment for fibrosis or both conditions, respectively. While detailed information on its effects on fibrosis is limited, the treatment may help by loosening tight bands under the skin. Overall, AVELI appears promising in improving skin appearance and reducing unwanted dimples. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 undergoing High-Definition Liposculpture with visible cellulite or fibrosis. Candidates should not be pregnant, have a history of scarring or healing issues, severe skin conditions, obesity, or significant other health problems.

Inclusion Criteria

American Association of Anesthesiologist Risk Assessment (ASA) ≤ 2

Body Mass Index (BMI) ≥20 and ≤ 32 kg/m2

I am planning to have cosmetic surgery not related to treating fibrosis or cellulite.

Exclusion Criteria

I am currently smoking or quit smoking within the last 4 to 8 weeks.

Patients with prothrombin time (PT) and/or activated partial thromboplastin time (aPTT) >1.5 times baseline

I have a history of epilepsy or vascular disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo High-Definition Liposculpture with AVELI applied to identified cellulite and for fibrosis release

Immediate procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with photographic and 3D imaging at follow-ups

9 months

4 visits (in-person) at 1, 3, 6, and 9 months

What Are the Treatments Tested in This Trial?

Interventions

• AVELI

Trial Overview The study tests AVELI's safety and effectiveness in reducing cellulite and fibrotic tissue during body contouring surgery. It involves three groups: one with cellulite, another with fibrosis, and the third with both. Outcomes are measured by absence of serious events and aesthetic improvement scales.

How Is the Trial Designed?

Group I: Fibrosis and Cellulite Group (FCG) Experimental Treatment 1 Intervention

Patients with any degree of clinically evident cellulite AND fibrosis undergoing non-primary HDL + AVÉLI treatment for both.

Group II: Fibrosis Group (FG) Experimental Treatment 1 Intervention

Patients with any degree of fibrosis undergoing non-primary HDL + AVÉLI release of fibrotic tissue.

Group III: Cellulite group (CG) Experimental Treatment 1 Intervention

Patients with any degree of clinically evident cellulite undergoing HDL + AVÉLI treatment for Cellulite.

Who Is Running the Clinical Trial?

Total Definer Research Group

Lead Sponsor

Trials

5

Recruited

620+

Published Research Related to This Trial

Cellulite is a common cosmetic issue in post-adolescent women, characterized by a dimpled appearance due to factors like excess subcutaneous fat and differences in tissue structure, and while weight loss can improve its appearance, it may not significantly change skin dimpling in obese individuals.

Treatments such as massage and topical creams containing agents like xanthines and botanicals have shown some effectiveness in improving the appearance of cellulite, with certain supplements like conjugated linoleic acid (CLA) also demonstrating benefits, suggesting a combination of oral and topical treatments may be most effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cellulite and its treatment. Rawlings, AV.[2008]

In a study involving 60 subjects, three noninvasive treatment techniques—mechanical massage, manual lymphatic drainage, and connective tissue manipulation—were all effective in reducing subcutaneous fat thickness in patients with cellulite, with significant improvements observed (P < 0.05).

Among the techniques, connective tissue manipulation showed the greatest reduction in thigh fat thickness (3.03 mm), while manual lymphatic drainage also performed well, indicating that different methods can be effective for fat reduction in targeted areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of mechanical massage, manual lymphatic drainage and connective tissue manipulation techniques on fat mass in women with cellulite. Bayrakci Tunay, V., Akbayrak, T., Bakar, Y., et al.[2022]

In a clinical trial with 17 patients, Acoustic Wave Therapy (AWT) showed significant improvements in cellulite treatment, including reduced dimples and improved skin texture, with a statistically significant effect size (MW = 0.6706).

The study found no side effects associated with AWT, indicating that it is a safe treatment option for patients dealing with cellulite.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo controlled, prospectively randomized, double-blinded study for the investigation of the effectiveness and safety of the acoustic wave therapy (AWT(®)) for cellulite treatment. Russe-Wilflingseder, K., Russe, E., Vester, JC., et al.[2015]

In a study of 60 female volunteers, a herbal anticellulite pill combined with conjugated linoleic acid supplements improved the appearance of cellulite in 75% of participants over 60 days.

Participants also experienced a significant reduction in thigh circumference, averaging 0.88 inches, suggesting potential efficacy of the treatment for reducing visible cellulite.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addition of conjugated linoleic acid to a herbal anticellulite pill. Birnbaum, L.[2019]

Intense pulsed light (IPL) treatment, with or without a retinyl-based cream, showed significant improvement in the appearance of cellulite in 75% of the 20 patients over a 12-week period, with 60% reporting at least 50% self-improvement.

Both treatment groups demonstrated increased collagen deposition confirmed by skin ultrasounds, indicating that IPL is a well-tolerated option for cellulite treatment with minimal side effects and high patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of intense pulsed light and a retinyl-based cream as a potential treatment for cellulite: a pilot study. Fink, JS., Mermelstein, H., Thomas, A., et al.[2020]

A clinical study involving women found that Cellasene, a product marketed for cellulite treatment, showed no significant effects on cellulite reduction, body weight, or fat content after 2 months compared to a placebo.

Most participants in both the Cellasene and placebo groups experienced weight gain, indicating that neither treatment was effective in achieving the desired outcomes related to cellulite or weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parallel placebo-controlled clinical study of a mixture of herbs sold as a remedy for cellulite. Lis-Balchin, M.[2019]

Cellfina is specifically effective for treating dimple-type cellulite, which is caused by fibrous bands pulling on the skin, leading to a puckered appearance.

Educating patients about the specific type of cellulite that Cellfina targets is crucial for optimizing treatment outcomes and managing expectations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cellfina observations: pearls and pitfalls. Green, JB., Cohen, JL.[2019]

In a study involving 83 participants, a low-level, dual-wavelength laser and massage device significantly reduced thigh circumference by an average of -0.64 cm compared to -0.20 cm in untreated areas, demonstrating its efficacy in improving the appearance of cellulite.

The treatment was found to be safe, with temporary side effects like erythema and swelling resolving within 30 minutes and no lasting complications, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction in thigh circumference and improvement in the appearance of cellulite with dual-wavelength, low-level laser energy and massage. Gold, MH., Khatri, KA., Hails, K., et al.[2015]

Topical application of siloxanetriol alginate caffeine (SAC) and caffeine on fatty tissue in Wistar female mice showed that SAC reduced the number of fatty cells by 26% and the diameter of fatty cells by 16%, indicating its effectiveness in combating cellulite.

Caffeine alone reduced the diameter of fatty cells by 17%, but the addition of sodium benzoate inhibited its effectiveness, suggesting that SAC is a more suitable formulation for promoting lipolytic action on fatty tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of caffeine and siloxanetriol alginate caffeine, as anticellulite agents, on fatty tissue: histological evaluation. Velasco, MV., Tano, CT., Machado-Santelli, GM., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36351188/

Multicenter Pivotal Study Demonstrates Safety and Efficacy ... Results: Clinically significant improvement in primary endpoint Cellulite Severity Scale scores were sustained out to 1 year, improving by 1.50 ...

2. drstephanieteotia.com drstephanieteotia.com/does-aveli-work/

Does Avéli Work? In the most extensive study to date, patient satisfaction reached 80% at three months from the date of the procedure and 93% one year out. These results ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06791564

Minimally Invasive Active Release of Septa Bands ... This prospective study aims to evaluate the safety and effectiveness of AVELI for reducing cellulite and fibrotic tissue in patients undergoing ...

4. metroderm.org metroderm.org/everyone-is-talking-about-aveli-the-new-and-transformative-cellulite-treatment/

EVERYONE IS TALKING ABOUT AVELI™ Individuals with Mild to Moderate Cellulite: Aveli treatment is particularly effective for those with mild to moderate cellulite. While severe cases may ...

5. laserlipoandveins.com laserlipoandveins.com/aveli-cellulite-treatment-does-it-really-work/

Avéli Cellulite Treatment: Does it Really Work? Study Results. Efficacy: 80% of patients showed significant improvement · Before Treatment. Consultation to assess cellulite type and suitability · During ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf21/K212399.pdf

October 22, 2021 NC8, Inc. (Revelle Aesthetics, Inc.) Mellissa ... Avéli is intended for temporary reduction in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by ...

7. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=22879920&pc=OUP

MAUDE Adverse Event Report: REVELLE AESTHETICS, INC ... It was reported that an aveli patient presented at one month post treatment with residual fluid retention at the treatment area.

8. myaveli.com myaveli.com/ifu/

Instructions For Use AVE001 - MyAveli Avéli® is indicated for long-term reduction in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data ...