100 Participants Needed

Combined Treatments for Facial Contouring

(US Harmony Trial)

Recruiting at 9 trial locations
AC
Overseen ByABBVIE CALL CENTER
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

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.678910

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.311121314

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

AI

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
See 6 more

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
1Treatment groups
Experimental Treatment
Group I: Open-Label Combination TreatmentsExperimental Treatment5 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).

Find a Clinic Near You

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 profile image

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.
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.
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.
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]

References

Facial Contouring by Using Dermal Fillers and Botulinum Toxin A: A Practical Approach. [2020]
Use of AbobotulinumtoxinA for Cosmetic Treatments in the Neck, and Middle and Lower Areas of the Face: A Systematic Review. [2021]
IncobotulinumtoxinA for the treatment of platysmal bands: a single-arm, prospective proof-of-concept clinical study. [2014]
Long-term treatment of glabellar rhytides using onabotulinumtoxina. [2018]
Phase 3 Study of OnabotulinumtoxinA Distributed Between Frontalis, Glabellar Complex, and Lateral Canthal Areas for Treatment of Upper Facial Lines. [2018]
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]
Report of Allergic Reaction After Application of Botulinum Toxin. [2016]
Complications from toxins and fillers in the dermatology clinic: recognition, prevention, and treatment. [2022]
Safety and Patient Satisfaction of AbobotulinumtoxinA for Aesthetic Use: A Systematic Review. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Delayed-onset complications of facial soft tissue augmentation with permanent fillers in 85 patients. [2013]
Topical skin therapies in subjects undergoing full facial rejuvenation. [2019]
OnabotulinumtoxinA and Hyaluronic Acid in Facial Wrinkles and Folds: A Prospective, Open-Label Comparison. [2020]
How to achieve synergy between volume replacement and filling products for global facial rejuvenation. [2011]
14.United Statespubmed.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]
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