AVELI for Cellulite

(AVE001 Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Total Definer Research Group

Must not be taking: Aspirin, Anticoagulants

Disqualifiers: Pregnancy, Obesity, Connective tissue disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This prospective study aims to evaluate the safety and effectiveness of AVELI for reducing cellulite and fibrotic tissue in patients undergoing High-Definition Liposculpture, exploring if AVELI improves the aesthetic outcomes, and reduced the clinically evident cellulite and/or fibrosis. AVELI is a minimally invasive procedure used for the treatment of cellulite. The main questions this study seeks to answer are: * Does AVELI safely reduce cellulite and fibrotic tissue without causing serious adverse events? * How effective is AVELI in improving patient-reported outcomes and aesthetic appearance? In this study, the research team will explore the use of AVELI for cellulite, fibrosis, and cellulite plus fibrosis, in 3 independent study arms. Through this study the safety and effectiveness aims to be evaluated. The participants will be adult patients (between 18-60 years) undergoing High-Definition Liposculpture, with clinical evidence of cellulite and/or fibrosis. The participants can not be pregnant, have history of scaring/healing problems, severe dermatological conditions, be obese, or have important comorbidities. The study procedures include: * Baseline data collection. * All patients will undergo the standardized High-Definition Liposculpture technique, with AVELI applied to all identified cellulite and for fibrosis release. * Photographic and 3D imaging preoperatively and at follow-ups (1, 3, 6, and 9 months). Primary outcome: * Safety assessed by the absence of serious adverse events within 30 days. * Effectiveness evaluated using the Global Aesthetic Improvement Scale (GAIS) for patient satisfaction and 3D imaging analysis for objective evaluation. Secondary outcomes: \* Explore the aesthetic outcomes satisfaction with the High-Definition Liposculpture measured by participant-reported satisfaction (GAIS) and objective contour improvements (3D analysis).

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 data supports the effectiveness of the treatment AVELI for cellulite?

Research on cellulite treatments suggests that methods like massage and certain creams can improve skin appearance by reducing fat and increasing circulation. Additionally, treatments like Acoustic Wave Therapy have shown significant improvements in skin texture and firmness, which may indicate potential benefits for AVELI. ^{1 2 3 4 5}

How does the AVELI treatment for cellulite differ from other treatments?

AVELI is unique because it specifically targets the fibrous bands under the skin that cause the dimpled appearance of cellulite, unlike other treatments that focus on reducing fat or improving skin texture. ^{1 6 7 8 9}

Research Team

Eligibility Criteria

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.

I have a history of epilepsy or vascular disease.

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

Trial Timeline

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

Treatment Details

Interventions

• AVELI (Procedure)

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Cellulite and its treatment. [2008]

2. England pubmed.ncbi.nlm.nih.gov

Effects of mechanical massage, manual lymphatic drainage and connective tissue manipulation techniques on fat mass in women with cellulite. [2022]

3. England 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. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Use of intense pulsed light and a retinyl-based cream as a potential treatment for cellulite: a pilot study. [2020]

5. England 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. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

Effects of caffeine and siloxanetriol alginate caffeine, as anticellulite agents, on fatty tissue: histological evaluation. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Cellfina observations: pearls and pitfalls. [2019]