Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Open-Label Combination Treatments | Experimental | 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). |
|
| Cohort 2: Open-Label Combination Treatments | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OnabotulinumtoxinA | Drug | Intramuscular Injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Satisfaction with Facial Appearance Scale at the Final Visit | The FACE-Q Satisfaction with Facial Appearance is a validated questionnaire that asks participants to report their level of satisfaction with the appearance of their face. | Up to approximately 284 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Psychological Function Scale at the Final Visit | The FACE-Q Psychological Function is a validated questionnaire that asks participants to report their level of satisfaction with psychological function. | Up to approximately 284 days |
Not provided
Inclusion Criteria:
Applies to All Participants:
Must meet at least 1 of the following criteria for BOTOX UFL treatment per investigator's assessment:
Must meet at least 3 of the following criteria for treatment in the face with at least 2 JUVÉDERM products, per investigator's assessment:
Applies only to participants who will be treated for submental fullness:
- Moderate or severe on the Clinician-reported Submental Fat Rating Scale (for KYBELLA treatment) or Moderate, severe, or extreme (For CoolSculpting Elite treatment) per investigator's assessment.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marcus Facial Plastic Surgery /ID# 270408 | Redondo Beach | California | 90277 | United States | ||
| Pacific Clinical Innovations /ID# 270414 |
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| JUVÉDERM | Device | Injections |
|
|
| CoolSculpting Elite System | Device | CoolSculpting Elite Applicator |
|
| SkinMedica Products | Other | Skincare Product |
|
| KYBELLA | Drug | Injections |
|
| Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Social Function Scale at the Final Visit |
The FACE-Q Social Function Scale is a validated questionnaire that asks participants to report their level of satisfaction with social function. |
| Up to approximately 284 days |
| Change from Baseline in the Participant's Rasch-Transformed Score of the SKIN-Q Scale at the Final Visit | The SKIN-Q Scale is a validated questionnaire that asks participants to report their level of satisfaction with skin quality. | Up to approximately 284 days |
| Vista |
| California |
| 92083-6030 |
| United States |
| Center for Dermatology and Dermatologic Surgery /ID# 270390 | Washington D.C. | District of Columbia | 20037-1495 | United States |
| Skin Research Institute LLC /ID# 270410 | Coral Gables | Florida | 33146-1837 | United States |
| DelRicht Research - Prytania Street - New Orleans 308 /ID# 270425 | New Orleans | Louisiana | 70115 | United States |
| Boyd /Id# 270509 | Birmingham | Michigan | 48009-6301 | United States |
| Luxurgery /ID# 270430 | New York | New York | 10021 | United States |
| Bellaire Dermatology Associates /ID# 270429 | Bellaire | Texas | 77401 | United States |
| Integrated Aesthetics /ID# 270399 | Spring | Texas | 77388 | United States |
| SkinDC /ID# 270411 | Arlington | Virginia | 22209 | United States |
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D003840 | Deoxycholic Acid |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |
Not provided
Not provided