A Study to Evaluate Participant Satisfaction With Facial... | NCT03712449

NCT03712449

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BELKYRA Treatment	Experimental	BELKYRA was injected into the subcutaneous fat for maximum of 6 treatments, 1 month apart from Month 0 to Month 5. Maximum dose did not exceed 100 milligrams (mg) [10 milliliters (mL)] in a single treatment. SkinMedica products: (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 6 to Month 11. Facial filler injectable treatment (JUVÉDERM VOLBELLA with Lidocaine and/or JUVÉDERM VOLIFT with Lidocaine and/or JUVÉDERM VOLUMA with Lidocaine and/or JUVÉDERM VOLITE with Lidocaine) from Month 6 to Month 8. The volume of filler injected at initial and touch-up treatments was determined by the investigator. BOTOX Cosmetic 20 units (U) to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U total injected to forehead lines at Month 9 and Month 10.	Device: JUVÉDERM® Drug: BOTOX Cosmetic® Drug: BELKYRA® Other: SkinMedica
Non-BELKYRA Treatment	Experimental	Participants who did not receive BELKYRA. SkinMedica products: (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 0 to Month 5. Facial filler injectable treatment (JUVÉDERM VOLBELLA with Lidocaine and/or JUVÉDERM VOLIFT with Lidocaine and/or JUVÉDERM VOLUMA with Lidocaine and/or JUVÉDERM VOLITE with Lidocaine) from Month 0 to Month 2. The volume of filler injected at initial and touch-up treatments was determined by the investigator. BOTOX Cosmetic 20 units (U) to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U total injected to forehead lines at Month 3 and Month 4.	Device: JUVÉDERM® Drug: BOTOX Cosmetic® Other: SkinMedica

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JUVÉDERM®	Device	Facial filler injection (JUVÉDERM VOLBELLA with Lidocaine, and/or JUVÉDERM VOLIFT with Lidocaine, and/or JUVÉDERM VOLUMA with Lidocaine, and/or JUVÉDERM VOLITE with Lidocaine) from Month 6 to Month 8 (BELKYRA Treatment) and Month 0 to Month 2 (Non-BELKYRA Treatment).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Rasch-transformed Score of FACE-Q Satisfaction With Facial Appearance Overall Scale to End of Study	The participant assessed satisfaction using the 10 items on the FACE-Q: Satisfaction with Facial Appearance questionnaire measured on a 4-point scale where 1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, and 4=very satisfied. The responses to the items were converted to a 100-point Rasch transformed scale score with 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement.	Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Participant's Assessment of Expectations of Life Change as Measured by Rasch-transformed Score of FACE-Q Expectations Scale to End of Study	The participant assessed expectations of life change using the FACE-Q questionnaire measured on a 4-point expectations scale where 1=definitely disagree, 2=somewhat disagree, 3=somewhat agree, 4=definitely agree. The responses to the items on the questionnaire were converted to a 100-point Rasch transformed scale score with 0 (worst) to 100 (best). A positive change from Baseline indicates improvement.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Accept the obligation not to receive any other facial procedures or treatments at any time during the study that are not related to the study
Women of childbearing potential must have a negative urine pregnancy test before each injectable treatment and practice a reliable method of contraception throughout the study
Willing to avoid direct and prolonged sun exposure to the facial skin, which includes tanning beds, for the duration of the study

Exclusion Criteria:

History of any intervention to treat submental fat (SMF) (e.g. liposuction, surgery, or lipolytic agents)
History of trauma associated with the chin or neck areas that in the judgment of the investigator may affect evaluation of safety or efficacy of treatment
An anatomical feature (e.g. predominant subplatysmal fat, loose skin in the neck or chin area, prominent platysmal bands) for which reduction in SMF may, in the judgment of the investigator, result in an aesthetically unacceptable outcome
Evidence of any cause of enlargement in the submental area (e.g. thyroid enlargement, cervical adenopathy, ptotic submandibular gland) other than localized SMF
Any medical condition (e.g. respiratory, cardiovascular, hepatic, neurological disease, or thyroid dysfunction) that would interfere with assessment of safety or efficacy or compromise the participant's ability to undergo study procedures or give informed consent
Body mass index (BMI) > 30
Known allergy or sensitivity to the study products or their components
Pregnant, lactating, or planning to become pregnant at any time during the study
Received BOTOX Cosmetic® or treatment with any other botulinum toxin product for any condition at any time prior to entry in the study
Received (or is planning to receive) anticoagulation, antiplatelet or thrombolytic medications (e.g. warfarin) or other substances known to increase coagulation time from 10 days prior to injection and up to 3 days post-injection
Undergone plastic surgery of the face and/or neck, tissue grafting, or tissue augmentation with silicone, fat, or other permanent dermal fillers, or be planning to undergo any of these procedures at any time during the study
Received temporary or semi-permanent facial or neck dermal filler injections (e.g. hyaluronic acid (HA), calcium hydroxylapatite, L-polylactic acid) at any time prior to entry in the study
Received mesotherapy, skin resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, or non-ablative procedures) in the face or neck within 6 months prior to study enrollment
Began use of any new over-the-counter (OTC) or prescription, oral or topical, antiwrinkle products on the facial area within 90 days prior to enrollment or planning to begin use of such products at any time during the study
Lip tattoos, facial hair or scars that would interfere with visualization of the lips and perioral area for the effectiveness assessments
Received any investigational product within 60 days prior to study enrollment or planning to participate in another investigation during the course of this study
An employee (or a relative of an employee) of the investigators, Allergan, or representative of Allergan
Current use of oral corticosteroids
Current use of nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g. aspirin, ibuprofen) with the exception of a daily low dose of aspirin, from 10 days prior to injection up to 3 days post-injection
Prescription topical retinoid therapy and/or topical hormone cream applied to the face, for potential participants who have not been on a consistent dose regimen for at least 6 months prior to enrollment and who are unable to maintain regimen for the study
Systemic retinoid therapy within one year prior to study enrollment
Medical condition that may increase the risk of exposure to botulinum toxin including diagnosed myasthenia gravis, Eaton-Lambert Syndrome, amyotrophic lateral sclerosis, or any other disease that might interfere with neuromuscular function
Current use of aminoglycoside antibiotics, curare-like agents, or agents that might interfere with neuromuscular (skeletal) function
History of facial nerve palsy
Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study treatment)
Tendency to accumulate fluid in the lower eyelids, or large infraorbital fat pads, i.e., significant convexity or projection from the infraorbital fat pads
Mid-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases such as generalized lipodystrophy (e.g. juvenile dermatomyositis), partial lipodystrophy (e.g. Barraquer-Simons syndrome), inherited disease, or human immunodeficiency virus-related disease
Undergone oral surgery or other dental procedures (e.g. tooth extraction, orthodontia, or implantation) within 30 days prior to enrollment or be planning to undergo any of these procedures during the study
Participants with neuromuscular disorders including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise
Participants with a history of allergies or hypersensitivity to HA or lidocaine

Contacts/Locations Module

Name	Affiliation	Role
Sara Sangha	Allergan	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Carruthers & Humphrey Cosmetic Dermatology		Vancouver	British Columbia	BC V5Z 4E1	Canada
Shannon Humphrey

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	BELKYRA Treatment	BELKYRA was injected into the subcutaneous fat for maximum of 6 treatments, 1 month apart from Month 0 to Month 5. Maximum dose did not exceed 100 mg [10 mL] in a single treatment. SkinMedica products: (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 6 to Month 11. Facial filler injectable treatment (JUVÉDERM VOLBELLA with Lidocaine and/or JUVÉDERM VOLIFT with Lidocaine and/or JUVÉDERM VOLUMA with Lidocaine and/or JUVÉDERM VOLITE with Lidocaine) from Month 6 to Month 8. The volume of filler injected at initial and touch-up treatments was determined by the investigator. BOTOX Cosmetic 20 units (U) to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U total injected to forehead lines at Month 9 and Month 10.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 24, 2018	Jul 29, 2021

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Full Analysis Population included all participants who had met all eligibility criteria at the screening visit and received any product used as treatment in this study.

Arm/Group Information

ID	Title	Description
BG000	BELKYRA Treatment	BELKYRA was injected into the subcutaneous fat for maximum of 6 treatments, 1 month apart from Month 0 to Month 5. Maximum dose did not exceed 100 mg [10 mL] in a single treatment. SkinMedica products: (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 6 to Month 11. Facial filler injectable treatment (JUVÉDERM VOLBELLA with Lidocaine and/or JUVÉDERM VOLIFT with Lidocaine and/or JUVÉDERM VOLUMA with Lidocaine and/or JUVÉDERM VOLITE with Lidocaine) from Month 6 to Month 8. The volume of filler injected at initial and touch-up treatments was determined by the investigator. BOTOX Cosmetic 20 units (U) to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U total injected to forehead lines at Month 9 and Month 10.
BG001	Non-BELKYRA Treatment	Participants who did not receive BELKYRA. SkinMedica products: (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 0 to Month 5. Facial filler injectable treatment (JUVÉDERM VOLBELLA with Lidocaine and/or JUVÉDERM VOLIFT with Lidocaine and/or JUVÉDERM VOLUMA with Lidocaine and/or JUVÉDERM VOLITE with Lidocaine) from Month 0 to Month 2. The volume of filler injected at initial and touch-up treatments was determined by the investigator. BOTOX Cosmetic 20 units (U) to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U total injected to forehead lines at Month 3 and Month 4.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00013 BG00145 BG00258

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Baseline

Title	Measurements
	OG00040.9± 16.79 OG00137.8± 10.96

Change from Baseline to End of Study

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000		Paired t-test/Wilcoxon Signed Rank Test		0.0009														Other	The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.
OG001		Paired t-test/Wilcoxon Signed Rank Test

Secondary

Change From Baseline in Participant's Assessment of Expectations of Life Change as Measured by Rasch-transformed Score of FACE-Q Expectations Scale to End of Study

The participant assessed expectations of life change using the FACE-Q questionnaire measured on a 4-point expectations scale where 1=definitely disagree, 2=somewhat disagree, 3=somewhat agree, 4=definitely agree. The responses to the items on the questionnaire were converted to a 100-point Rasch transformed scale score with 0 (worst) to 100 (best). A positive change from Baseline indicates improvement.

Posted

Mean

Standard Deviation

score on a scale

Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)

ID	Title	Description
OG000	BELKYRA Treatment	BELKYRA was injected into the subcutaneous fat for maximum of 6 treatments, 1 month apart from Month 0 to Month 5. Maximum dose did not exceed 100 mg [10 mL] in a single treatment. SkinMedica products: (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 6 to Month 11. Facial filler injectable treatment (JUVÉDERM VOLBELLA with Lidocaine and/or JUVÉDERM VOLIFT with Lidocaine and/or JUVÉDERM VOLUMA with Lidocaine and/or JUVÉDERM VOLITE with Lidocaine) from Month 6 to Month 8. The volume of filler injected at initial and touch-up treatments was determined by the investigator. BOTOX Cosmetic 20 units (U) to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U total injected to forehead lines at Month 9 and Month 10.

Secondary

Change From Baseline in Participant's Assessment of Age-related Facial Appearance as Measured by Rasch-transformed Score of FACE-Q Aging Appraisal Scale to End of Study

The participant assessed age-related facial appearance using the FACE-Q questionnaire measured on a 4-point aging appraisal scale where 1=definitely disagree, 2=somewhat disagree, 3=somewhat agree, 4=definitely agree. The responses to the items on the questionnaire were converted to a 100-point Rasch transformed scale score. Lower scores indicated better outcome and responders were defined as having achieved a younger category. A negative change from Baseline indicates improvement.

Posted

Mean

Standard Deviation

score on a scale

Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)

ID	Title	Description
OG000	BELKYRA Treatment	BELKYRA was injected into the subcutaneous fat for maximum of 6 treatments, 1 month apart from Month 0 to Month 5. Maximum dose did not exceed 100 mg [10 mL] in a single treatment. SkinMedica products: (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 6 to Month 11. Facial filler injectable treatment (JUVÉDERM VOLBELLA with Lidocaine and/or JUVÉDERM VOLIFT with Lidocaine and/or JUVÉDERM VOLUMA with Lidocaine and/or JUVÉDERM VOLITE with Lidocaine) from Month 6 to Month 8. The volume of filler injected at initial and touch-up treatments was determined by the investigator. BOTOX Cosmetic 20 units (U) to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U total injected to forehead lines at Month 9 and Month 10.

Secondary

Change From Baseline in Participant's Assessment of Psychological Well-being as Measured by Rasch-transformed Score of FACE-Q Psychological Function Scale to End of Study

The participant assessed psychological well-being using the FACE-Q questionnaire measured on a 4-point psychological function scale where 1=definitely disagree, 2=somewhat disagree, 3=somewhat agree, 4=definitely agree. The responses to the items on the questionnaire were converted to a 100-point Rasch transformed scale score with 0 (worst) to 100 (best). Higher scores indicate higher well-being. A positive change from Baseline indicates improvement.

Posted

Mean

Standard Deviation

score on a scale

Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)

ID	Title	Description
OG000	BELKYRA Treatment	BELKYRA was injected into the subcutaneous fat for maximum of 6 treatments, 1 month apart from Month 0 to Month 5. Maximum dose did not exceed 100 mg [10 mL] in a single treatment. SkinMedica products: (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 6 to Month 11. Facial filler injectable treatment (JUVÉDERM VOLBELLA with Lidocaine and/or JUVÉDERM VOLIFT with Lidocaine and/or JUVÉDERM VOLUMA with Lidocaine and/or JUVÉDERM VOLITE with Lidocaine) from Month 6 to Month 8. The volume of filler injected at initial and touch-up treatments was determined by the investigator. BOTOX Cosmetic 20 units (U) to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U total injected to forehead lines at Month 9 and Month 10.

Secondary

Change From Baseline in Participant's Assessment of Social Function as Measured by Rasch-transformed Score of FACE-Q Social Function Scale to End of Study

The participant assessed social function using the FACE-Q questionnaire measured on a 4-point social function scale where 1=definitely disagree, 2=somewhat disagree, 3=somewhat agree, 4=definitely agree. The responses to the items on the questionnaire were converted to a 100-point Rasch transformed scale score with 0 (worst) to 100 (best). Higher scores indicate higher social function. A positive change from Baseline indicates improvement.

Evaluable Population included all participants as defined in the Full Analysis Population who had at least one post treatment efficacy assessment at the final visit. Full Analysis Population included all participants who had met all eligibility criteria at the screening visit received any product used as treatment in this study.

Posted

Mean

Standard Deviation

score on a scale

Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)

ID	Title	Description
OG000	BELKYRA Treatment	BELKYRA was injected into the subcutaneous fat for maximum of 6 treatments, 1 month apart from Month 0 to Month 5. Maximum dose did not exceed 100 mg [10 mL] in a single treatment. SkinMedica products: (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 6 to Month 11. Facial filler injectable treatment (JUVÉDERM VOLBELLA with Lidocaine and/or JUVÉDERM VOLIFT with Lidocaine and/or JUVÉDERM VOLUMA with Lidocaine and/or JUVÉDERM VOLITE with Lidocaine) from Month 6 to Month 8. The volume of filler injected at initial and touch-up treatments was determined by the investigator. BOTOX Cosmetic 20 units (U) to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U total injected to forehead lines at Month 9 and Month 10.

Secondary

Change From Baseline in Participant's Assessment of Overall Satisfaction With Skin as Measured by Rasch-transformed Score of FACE-Q Satisfaction With Skin Scale to End of Study

The participant assessed overall satisfaction with skin using the FACE-Q questionnaire measured on a 4-point scale where 1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, and 4=very satisfied. The responses to the items on the questionnaire were converted to a 100-point Rasch transformed scale score with 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement.

Posted

Mean

Standard Deviation

score on a scale

Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)

ID	Title	Description
OG000	BELKYRA Treatment	BELKYRA was injected into the subcutaneous fat for maximum of 6 treatments, 1 month apart from Month 0 to Month 5. Maximum dose did not exceed 100 mg [10 mL] in a single treatment. SkinMedica products: (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 6 to Month 11. Facial filler injectable treatment (JUVÉDERM VOLBELLA with Lidocaine and/or JUVÉDERM VOLIFT with Lidocaine and/or JUVÉDERM VOLUMA with Lidocaine and/or JUVÉDERM VOLITE with Lidocaine) from Month 6 to Month 8. The volume of filler injected at initial and touch-up treatments was determined by the investigator. BOTOX Cosmetic 20 units (U) to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U total injected to forehead lines at Month 9 and Month 10.

Secondary

Number of Participants With Participant's Assessment of Age-related Facial Appearance as Measured by Self-perception of Age (SPA) Questionnaire (Item 1)

Posted

Count of Participants

Participants

Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)

ID	Title	Description
OG000	BELKYRA Treatment	BELKYRA was injected into the subcutaneous fat for maximum of 6 treatments, 1 month apart from Month 0 to Month 5. Maximum dose did not exceed 100 mg [10 mL] in a single treatment. SkinMedica products: (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 6 to Month 11. Facial filler injectable treatment (JUVÉDERM VOLBELLA with Lidocaine and/or JUVÉDERM VOLIFT with Lidocaine and/or JUVÉDERM VOLUMA with Lidocaine and/or JUVÉDERM VOLITE with Lidocaine) from Month 6 to Month 8. The volume of filler injected at initial and touch-up treatments was determined by the investigator. BOTOX Cosmetic 20 units (U) to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U total injected to forehead lines at Month 9 and Month 10.

Secondary

Change From Baseline in Participant's Assessment of Age-related Facial Appearance as Measured by SPA Questionnaire (Items 2 and 3) to End of Study

The participant assessed age-related facial appearance using the 3 items on the SPA Questionnaire. Participants were asked 'how they think of their facial appearance looks compared to their age on the day of assessment' and participants had to respond in any one of the following responses: 1) I look my current age, or 2) I look (enter number of years) years younger, or 3) I look (enter number of years) years older. Results for Items 2 and 3 are reported. The higher number of years in Item 2 implies better self-perception of age; a positive change from Baseline indicates improvement. The fewer number of years in Item 3 implies better self-perception of age; a negative change from Baseline indicates improvement.

Posted

Median

Full Range

years

Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)

ID	Title	Description
OG000	BELKYRA Treatment	BELKYRA was injected into the subcutaneous fat for maximum of 6 treatments, 1 month apart from Month 0 to Month 5. Maximum dose did not exceed 100 mg [10 mL] in a single treatment. SkinMedica products: (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 6 to Month 11. Facial filler injectable treatment (JUVÉDERM VOLBELLA with Lidocaine and/or JUVÉDERM VOLIFT with Lidocaine and/or JUVÉDERM VOLUMA with Lidocaine and/or JUVÉDERM VOLITE with Lidocaine) from Month 6 to Month 8. The volume of filler injected at initial and touch-up treatments was determined by the investigator. BOTOX Cosmetic 20 units (U) to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U total injected to forehead lines at Month 9 and Month 10.

Secondary

Number of Participants by Global Aesthetic Improvement Scale (GAIS) Categories as Assessed by the Investigator

The investigator assessed the participant's improvement from Baseline to the End of Study using the GAIS where: 2=Much Improved, 1=Improved, 0=No Change, -1=Worse and -2=Much Worse.

Posted

Count of Participants

Participants

Baseline (Prior to Treatment) to the End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)

ID	Title	Description
OG000	BELKYRA Treatment	BELKYRA was injected into the subcutaneous fat for maximum of 6 treatments, 1 month apart from Month 0 to Month 5. Maximum dose did not exceed 100 mg [10 mL] in a single treatment. SkinMedica products: (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 6 to Month 11. Facial filler injectable treatment (JUVÉDERM VOLBELLA with Lidocaine and/or JUVÉDERM VOLIFT with Lidocaine and/or JUVÉDERM VOLUMA with Lidocaine and/or JUVÉDERM VOLITE with Lidocaine) from Month 6 to Month 8. The volume of filler injected at initial and touch-up treatments was determined by the investigator. BOTOX Cosmetic 20 units (U) to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U total injected to forehead lines at Month 9 and Month 10.

Secondary

Number of Participants by Global Aesthetic Improvement Scale (GAIS) Categories as Assessed by the Participant

The participants self-assessed their improvement from Baseline to the End of Study using the GAIS where: 2=Much Improved, 1=Improved, 0=No Change, -1=Worse and -2=Much Worse.

Posted

Count of Participants

Participants

Baseline (Prior to Treatment) to the End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)

ID	Title	Description
OG000	BELKYRA Treatment	BELKYRA was injected into the subcutaneous fat for maximum of 6 treatments, 1 month apart from Month 0 to Month 5. Maximum dose did not exceed 100 mg [10 mL] in a single treatment. SkinMedica products: (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 6 to Month 11. Facial filler injectable treatment (JUVÉDERM VOLBELLA with Lidocaine and/or JUVÉDERM VOLIFT with Lidocaine and/or JUVÉDERM VOLUMA with Lidocaine and/or JUVÉDERM VOLITE with Lidocaine) from Month 6 to Month 8. The volume of filler injected at initial and touch-up treatments was determined by the investigator. BOTOX Cosmetic 20 units (U) to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U total injected to forehead lines at Month 9 and Month 10.

Secondary

Change From Baseline in the Periorbital Aesthetic Appearance Questionnaire (PAAQ) Total Score

The PAAQ consists of 9 questions answered by the participant about their satisfaction with their eye appearance over the past 7 days. Each question is answered using a 5-point scale where: 0=Never (best) to 4=all of the time (worst). The responses to the items on the questionnaire were converted to a 100-point Rasch transformed scale score with 0 (best) to 100 (worst). Lower scores indicate higher satisfaction. A negative change from Baseline indicates improvement.

Posted

Mean

Standard Deviation

score on a scale

Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)

ID	Title	Description
OG000	BELKYRA Treatment	BELKYRA was injected into the subcutaneous fat for maximum of 6 treatments, 1 month apart from Month 0 to Month 5. Maximum dose did not exceed 100 mg [10 mL] in a single treatment. SkinMedica products: (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 6 to Month 11. Facial filler injectable treatment (JUVÉDERM VOLBELLA with Lidocaine and/or JUVÉDERM VOLIFT with Lidocaine and/or JUVÉDERM VOLUMA with Lidocaine and/or JUVÉDERM VOLITE with Lidocaine) from Month 6 to Month 8. The volume of filler injected at initial and touch-up treatments was determined by the investigator. BOTOX Cosmetic 20 units (U) to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U total injected to forehead lines at Month 9 and Month 10.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	BELKYRA Treatment	BELKYRA was injected into the subcutaneous fat for maximum of 6 treatments, 1 month apart from Month 0 to Month 5. Maximum dose did not exceed 100 mg [10 mL] in a single treatment. SkinMedica products: (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 6 to Month 11. Facial filler injectable treatment (JUVÉDERM VOLBELLA with Lidocaine and/or JUVÉDERM VOLIFT with Lidocaine and/or JUVÉDERM VOLUMA with Lidocaine and/or JUVÉDERM VOLITE with Lidocaine) from Month 6 to Month 8. The volume of filler injected at initial and touch-up treatments was determined by the investigator. BOTOX Cosmetic 20 units (U) to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U total injected to forehead lines at Month 9 and Month 10.	0	13	0	13	9	13
EG001	Non-BELKYRA Treatment	Participants who did not receive BELKYRA. SkinMedica products: (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 0 to Month 5. Facial filler injectable treatment (JUVÉDERM VOLBELLA with Lidocaine and/or JUVÉDERM VOLIFT with Lidocaine and/or JUVÉDERM VOLUMA with Lidocaine and/or JUVÉDERM VOLITE with Lidocaine) from Month 0 to Month 2. The volume of filler injected at initial and touch-up treatments was determined by the investigator. BOTOX Cosmetic 20 units (U) to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U total injected to forehead lines at Month 3 and Month 4.	0	46	0	45	20	45

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Oedema	General disorders	MedDRA 21.0	Systematic Assessment	EG0004 affected13 at risk EG0010 affected45 at risk
Pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected13 at risk EG0010 affected45 at risk
Injection site reaction	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected13 at risk EG0012 affected45 at risk
Nodule	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected13 at risk EG0012 affected45 at risk
Cyst	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected45 at risk
Injection site bruising	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected45 at risk
Injection site pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected45 at risk
Injection site swelling	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected45 at risk
Mass	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected45 at risk
Swelling	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected45 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected13 at risk EG0012 affected45 at risk
Herpes simplex	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected45 at risk
Herpes zoster	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected45 at risk
Nasopharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected45 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected45 at risk
Post procedural cellulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected45 at risk
Sinusitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected45 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected45 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected45 at risk
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected13 at risk EG0014 affected45 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 affected13 at risk EG0011 affected45 at risk
Injury of conjunctiva	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected45 at risk
Dysaesthesia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected13 at risk EG0010 affected45 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected45 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected45 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected13 at risk EG0012 affected45 at risk
Brow ptosis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected45 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected45 at risk
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected45 at risk
Skin mass	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected45 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected45 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected45 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected45 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected45 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected45 at risk
Salivary gland pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected45 at risk

ID	Term
D019274	Botulinum Toxins, Type A

Ancestor Terms

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