Combined Treatments for Facial Contouring

(US Harmony Trial)

Recruiting at 9 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

100 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment for facial contouring?

Research shows that botulinum toxin A, a component of the treatment, is effective in reducing facial lines and improving the appearance of the neck, which suggests it may help with facial contouring. Additionally, studies on similar treatments have shown positive results in reducing wrinkles and enhancing facial features. ^{1 2 3 4 5}

Is the combined treatment for facial contouring safe?

The treatments involved in facial contouring, like OnabotulinumtoxinA and fillers, generally have a good safety record when used by qualified professionals. However, rare allergic reactions and complications can occur, so it's important to discuss any concerns with your healthcare provider. ^{6 7 8 9 10}

How is the Combined Treatments for Facial Contouring different from other treatments?

This treatment is unique because it combines multiple approaches, including CoolSculpting Elite System, JUVÉDERM, KYBELLA, and OnabotulinumtoxinA, to target facial contouring. The combination of these treatments can provide enhanced results by addressing different aspects of facial aesthetics, such as fat reduction, volume enhancement, and wrinkle smoothing, in a single comprehensive approach. ^{3 11 12 13 14}

What is the purpose of this trial?

A study to evaluate overall participant satisfaction of face and neck appearance after treatment with onabotulinumtoxinA, JUVÉDERM® products, KYBELLA, CoolSculpting Elite, and select SkinMedica products in a diverse population.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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.

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

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

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

I have health issues that may worsen with Botox treatment.

History of hypersensitivity or allergy to specific substances

Timeline

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

Treatment Details

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.

Participant Groups

Group I: 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

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Facial Contouring by Using Dermal Fillers and Botulinum Toxin A: A Practical Approach. [2020]

2. Switzerland 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. [2021]

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

IncobotulinumtoxinA for the treatment of platysmal bands: a single-arm, prospective proof-of-concept clinical study. [2014]

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

Long-term treatment of glabellar rhytides using onabotulinumtoxina. [2018]

5. United States 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. [2018]

6. United States 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. [2022]

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

Report of Allergic Reaction After Application of Botulinum Toxin. [2016]

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

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

9. England pubmed.ncbi.nlm.nih.gov

Safety and Patient Satisfaction of AbobotulinumtoxinA for Aesthetic Use: A Systematic Review. [2022]

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

Delayed-onset complications of facial soft tissue augmentation with permanent fillers in 85 patients. [2013]

11. England pubmed.ncbi.nlm.nih.gov

Topical skin therapies in subjects undergoing full facial rejuvenation. [2019]

12. England pubmed.ncbi.nlm.nih.gov

OnabotulinumtoxinA and Hyaluronic Acid in Facial Wrinkles and Folds: A Prospective, Open-Label Comparison. [2020]

13. England pubmed.ncbi.nlm.nih.gov

How to achieve synergy between volume replacement and filling products for global facial rejuvenation. [2011]

14. United States 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. [2014]