Combined Treatments for Facial Contouring

(US Harmony Trial)

Recruiting at 10 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: AbbVie

Must not be taking: Weight loss medications

Disqualifiers: Myasthenia gravis, Hypersensitivity, Facial asymmetry, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 40 weeks

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores satisfaction with facial and neck appearance after using cosmetic treatments like Botox (OnabotulinumtoxinA), JUVÉDERM, KYBELLA, and CoolSculpting. These treatments aim to enhance facial contours by reducing lines or adding volume where needed. Individuals noticing moderate or severe changes, such as deep lines or less defined features, and who have not recently undergone certain cosmetic procedures, might be suitable candidates. Participants will receive a combination of treatments tailored to their specific needs. As a Phase 4 trial, these FDA-approved treatments have already proven effective, and the trial seeks to understand their benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using weight loss medications, you cannot continue them during the study.

What is the safety track record for these treatments?

Research has shown that using onabotulinumtoxinA and JUVÉDERM together for facial treatments is generally safe. Studies have found that patients tolerate these treatments well. Specifically, one study reported good safety results when using onabotulinumtoxinA and a 24-mg/mL cohesive HA gel filler, either separately or together.

These treatments have already received approval for other uses, suggesting they are likely safe. However, side effects can occur, such as temporary swelling or redness at the injection site. Discussing any concerns with a healthcare provider before joining a trial is always advisable. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for facial contouring because they combine the power of multiple proven therapies to achieve enhanced results. CoolSculpting Elite offers targeted fat reduction using controlled cooling, while JUVÉDERM provides volume and lift with hyaluronic acid fillers. KYBELLA targets and dissolves fat cells in specific areas, and OnabotulinumtoxinA (commonly known as Botox) reduces fine lines and wrinkles by relaxing facial muscles. By using these treatments together, there is potential for more comprehensive facial rejuvenation that addresses both volume loss and unwanted fat, offering a holistic approach to facial contouring that standard single treatments may not achieve.

What is the effectiveness track record for the combined treatments used in this trial for facial contouring?

Research has shown that onabotulinumtoxinA and JUVÉDERM, which participants in this trial will receive, effectively improve facial shape. Studies indicate that using these treatments together can reduce the appearance of enlarged pores and enhance features like lip fullness and the area around the mouth. Participants in these studies reported feeling up to three times more satisfied with their appearance after treatment. These positive results suggest that combining these treatments can noticeably improve the look of the face and neck. Overall, this combination effectively enhances facial appearance. ^{1 2 3 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for individuals seeking to improve their facial and neck appearance. Specific eligibility criteria are not provided, but typically participants should be in good health with realistic expectations about cosmetic procedures.

Inclusion Criteria

I am eligible for BOTOX treatment as per my doctor's evaluation.

For participants to be treated with submental fat, must meet specific criteria per investigator's assessment

I am eligible for facial treatment with at least 2 JUVÉDERM products as assessed by a doctor.

Exclusion Criteria

History of body weight change exceeding 10% over the 6 months prior to screening or anticipated body weight change exceeding 10% during the study period

History of hypersensitivity or allergy to specific substances

I have health issues that may worsen with Botox treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with onabotulinumtoxinA, JUVÉDERM products, KYBELLA, CoolSculpting Elite, and select SkinMedica products

Up to approximately 40 weeks

Follow-up

Participants are monitored for satisfaction with facial and neck appearance, psychological function, social function, and skin quality

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CoolSculpting Elite System
• JUVÉDERM
• KYBELLA
• OnabotulinumtoxinA
• SkinMedica Products

Trial Overview

The study tests the satisfaction of patients after using a combination of treatments: OnabotulinumtoxinA (Botox), JUVÉDERM fillers, KYBELLA injections for fat under the chin, CoolSculpting Elite for body contouring, and SkinMedica skincare products.

How Is the Trial Designed?

Group I: Cohort 2: Open-Label Combination Treatments Experimental Treatment 3 Interventions

All participants in the study will receive treatment with onabotulinumtoxinA and JUVÉDERM (specific products and indications will be at the discretion of the investigator and per participant eligibility criteria).

Group II: Cohort 1: Open-Label Combination Treatments Experimental Treatment 5 Interventions

All participants in the study will receive treatment with onabotulinumtoxinA and JUVÉDERM (specific products and indications will be at the discretion of the investigator and per participant eligibility criteria).

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

Botulinum toxin, specifically Chinese botulinum toxin serotype A (CBTX-A), is generally safe for cosmetic procedures, but there is a risk of allergic reactions, as demonstrated in a case involving a 44-year-old woman who developed urticarial plaques shortly after treatment.

The allergic reaction was confirmed by a positive skin test and managed effectively with antihistamines and corticosteroids, highlighting the importance of monitoring for adverse events even in commonly used treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Report of Allergic Reaction After Application of Botulinum Toxin. Careta, MF., Delgado, L., Patriota, R.[2016]

A systematic review of 364 papers identified 86 relevant studies on the safety and patient satisfaction of abobotulinumtoxinA for aesthetic use, indicating a thorough examination of its effects.

The review also considered the potential risks of neutralizing antibodies and systemic toxicity, highlighting the importance of understanding these factors in special populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Patient Satisfaction of AbobotulinumtoxinA for Aesthetic Use: A Systematic Review. Cohen, JL., Scuderi, N.[2022]

In a study of 85 patients with delayed-onset complications from permanent facial fillers, the type and timing of adverse events varied based on the filler material used and the patient's immune status, particularly noting that HIV-infected individuals had a higher incidence of abscess formation.

Complications often arose after dental or other invasive facial procedures, suggesting that such treatments near filler sites can trigger issues, highlighting the need for caution when using permanent fillers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delayed-onset complications of facial soft tissue augmentation with permanent fillers in 85 patients. Kadouch, JA., Kadouch, DJ., Fortuin, S., et al.[2013]

The study outlines a practical approach to facial contouring using hyaluronic acid implants and botulinum toxin A, tailored to different facial shapes based on the MD codes® system, which categorizes faces into six basic shapes.

Complications from these treatments were low and mostly mild, including temporary swelling and bruising, indicating a generally safe profile for these aesthetic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facial Contouring by Using Dermal Fillers and Botulinum Toxin A: A Practical Approach. Farolch-Prats, L., Nome-Chamorro, C.[2020]

A systematic review of 10 studies involving various cosmetic uses of abobotulinumtoxinA (aboBoNT-A) showed positive outcomes in reducing wrinkles and improving facial aesthetics, with no serious adverse events reported.

Patient satisfaction was high across the studies, indicating that aboBoNT-A is a safe and effective option for cosmetic treatments in the middle and lower face and neck, warranting further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of AbobotulinumtoxinA for Cosmetic Treatments in the Neck, and Middle and Lower Areas of the Face: A Systematic Review. Galadari, H., Galadari, I., Smit, R., et al.[2021]

Combining hyaluronic acid fillers and botulinum neurotoxin in the same syringe for facial rejuvenation has shown excellent clinical outcomes without compromising the effectiveness of either product.

This technique not only improves patient experience by reducing the number of needle sticks but also allows for more efficient treatment of the upper face, with larger studies planned to further explore optimal administration methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyaluronic acid filler and botulinum Neurotoxin delivered simultaneously in the same syringe for effective and convenient combination aesthetic rejuvenation therapy. Kenner, JR.[2014]

In a study of 45 toxin-naive women aged 30 to 50, onabotulinumtoxinA injections every 4 months significantly reduced glabellar lines, with 84% physician-rated and 80% participant-rated responders at month 20.

Participants reported high satisfaction with their appearance throughout the study, with no adverse events noted, indicating that onabotulinumtoxinA is a safe and effective long-term treatment for reducing facial wrinkles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term treatment of glabellar rhytides using onabotulinumtoxina. Dailey, RA., Philip, A., Tardie, G.[2018]

In a study involving 23 subjects, incobotulinumtoxinA effectively reduced the appearance of platysmal bands, with 100% of participants showing improvement by Day 8 after treatment.

The treatment was well-tolerated with no serious adverse events reported, and subjects reported significant satisfaction with their results, particularly at maximum tension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IncobotulinumtoxinA for the treatment of platysmal bands: a single-arm, prospective proof-of-concept clinical study. Prager, W., Bee, EK., Havermann, I., et al.[2014]

The combination of Juvéderm VOLUMA and Ultra products with botulinum toxin offers a safe and effective approach to facial rejuvenation, providing long-lasting and natural results due to their innovative 3-D technology.

Expert consensus suggests that using these products together can enhance outcomes beyond what each product can achieve alone, making them well-tolerated and easy to use in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to achieve synergy between volume replacement and filling products for global facial rejuvenation. Raspaldo, H., Aziza, R., Belhaouari, L., et al.[2011]

In a study of 20 subjects undergoing facial rejuvenation with abobotulinumtoxinA and hyaluronic acid, those using a more robust skin care regimen, including chemical peels and antioxidants, showed significant improvements in skin quality and self-esteem compared to a standard regimen.

Both treatment groups reported enhanced satisfaction and better first impressions, indicating that combining cosmeceutical therapies with injectable treatments can lead to better cosmetic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical skin therapies in subjects undergoing full facial rejuvenation. Dayan, SH., Bacos, JT., Ho, TT., et al.[2019]

A meta-analysis of 1678 participants from multiple studies confirmed that onabotulinumtoxinA is safe and well-tolerated for treating facial lines, with no significant difference in overall adverse event incidence compared to placebo.

The most common treatment-related adverse events were mild to moderate, including eyelid sensory disorder and eyelid ptosis, but these were infrequent and decreased with repeated treatments, indicating a favorable long-term safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of onabotulinumtoxinA in the treatment of facial lines: a meta-analysis of individual patient data from global clinical registration studies in 1678 participants. Brin, MF., Boodhoo, TI., Pogoda, JM., et al.[2022]

While cosmetic toxins generally have a good safety profile, adverse reactions can still occur, especially as the use of fillers becomes more widespread.

The article emphasizes the importance of proper training, injection techniques, and careful patient selection to minimize complications and manage common adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications from toxins and fillers in the dermatology clinic: recognition, prevention, and treatment. Dayan, SH.[2022]

In a study involving 787 subjects, onabotulinumtoxinA injections significantly improved the appearance of forehead lines, with 45.6% of those receiving 40 U and 53.0% of those receiving 64 U showing at least a 2-grade improvement on the Facial Wrinkle Scale after 30 days, compared to only 0.6% in the placebo group.

The treatment was well tolerated, indicating that onabotulinumtoxinA is a safe and effective option for addressing moderate to severe forehead lines, whether used alone or in combination with other facial areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 3 Study of OnabotulinumtoxinA Distributed Between Frontalis, Glabellar Complex, and Lateral Canthal Areas for Treatment of Upper Facial Lines. De Boulle, K., Werschler, WP., Gold, MH., et al.[2018]

In a study of 152 participants aged 25-65, both onabotulinumtoxinA and hyaluronic acid treatments significantly improved moderate to severe facial wrinkles, with 92% to 100% of subjects showing improvement at each visit.

Patients reported looking 3 to 6 years younger after treatment, and both therapies were well tolerated, indicating their safety and effectiveness in enhancing facial aesthetics regardless of the order in which they were administered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OnabotulinumtoxinA and Hyaluronic Acid in Facial Wrinkles and Folds: A Prospective, Open-Label Comparison. Cohen, JL., Swift, A., Solish, N., et al.[2020]

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Combined Treatments for Facial Contouring

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Multicenter, Randomized, Parallel-Group Study of the ...

Based on a range of end points, onabotulinumtoxinA and 24-mg/mL cohesive HA gel treatments are effective and safe when either alone or in ...