A Study to Evaluate Participant Satisfaction With Facial Appearance Overall and the Aesthetic and Psychosocial Impact of Combined Facial Treatment

Phase 4

Completed

Conditions: Facial Rhytides, Skin Folds, Loss of Volume and Skin Quality

Interventions: Device: JUVÉDERM®
Drug: BOTOX Cosmetic®
Drug: BELKYRA®
Other: SkinMedica

Registration Number: NCT03712449

Lead Sponsor: Allergan

Brief Summary: The objective of this study is to quantify the psychological and emotional impact of comprehensive aesthetic treatment with a portfolio of Allergan products by measuring the change in participant's satisfaction with facial appearance from baseline to the final study visit.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 59

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-BELKYRA Treatment	BOTOX Cosmetic®	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.
BELKYRA Treatment	SkinMedica	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.
BELKYRA Treatment	JUVÉDERM®	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.
BELKYRA Treatment	BOTOX Cosmetic®	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.
BELKYRA Treatment	BELKYRA®	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.
Non-BELKYRA Treatment	JUVÉDERM®	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.
Non-BELKYRA Treatment	SkinMedica	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Rasch-transformed Score of FACE-Q Satisfaction With Facial Appearance Overall Scale to End of Study	Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)	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.

Secondary Outcome Measures

Name	Time	Method
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	Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)	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.
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	Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)	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.
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	Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)	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.
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	Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)	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.
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	Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)	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.
Number of Participants by Global Aesthetic Improvement Scale (GAIS) Categories as Assessed by the Participant	Baseline (Prior to Treatment) to the End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)	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.
Change From Baseline in the Periorbital Aesthetic Appearance Questionnaire (PAAQ) Total Score	Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)	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.
Number of Participants With Participant's Assessment of Age-related Facial Appearance as Measured by Self-perception of Age (SPA) Questionnaire (Item 1)	Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)	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. Item 1: Number of participants who responded 'I look my current age' is reported.
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	Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)	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.
Number of Participants by Global Aesthetic Improvement Scale (GAIS) Categories as Assessed by the Investigator	Baseline (Prior to Treatment) to the End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)	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.

Trial Locations

Locations (7): Project Skin MD Vancouver
🇨🇦
Vancouver, British Columbia, Canada
Pacific Derm
🇨🇦
Vancouver, British Columbia, Canada
Carruthers & Humphrey Cosmetic Dermatology
🇨🇦
Vancouver, British Columbia, Canada
Shannon Humphrey
🇨🇦
Vancouver, British Columbia, Canada
Dermetics
🇨🇦
Burlington, Ontario, Canada
Dr Nowell Solish
🇨🇦
Toronto, Ontario, Canada
Bertucci MedSpa
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Woodbridge, Ontario, Canada