The primary objective of this study is to quantify the psychological, social, and emotional impact of comprehensive aesthetic treatment with a portfolio of the Sponsor's products by measuring the change in subject's satisfaction with facial appearance from baseline (before any treatment) to the final study visit
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
64
JUVÉDERM VOLBELLA with Lidocaine Treatment of any fine lines and medium-sized skin depressions. Can also be used for enhancement and pouting of the lips to correct structural defects such as asymmetry, contour deformities, volume loss. JUVÉDERM VOLIFT with Lidocaine Intended for the treatment of any deep skin depressions due to conditions such as premature aging. Can also be used for face contouring and volume restoration to correct facial structural defects such as asymmetry, contour deformities, volume loss in the lips, cheeks, chin, lower face. JUVÉDERM VOLUMA with Lidocaine Intended to restore volume of the face JUVÉDERM VOLITE with Lidocaine Intended for treatment, by filling, of superficial cutaneous depressions such as fine lines and for additional improvement of skin quality attributes such as hydration and elasticity. JUVÉDERM VOLUX with Lidocaine Intended to restore and generate facial volume in chin and mandible areas
Indicated for the treatment of hyperkinetic facial lines.
Hospital Regional da Asa Norte - Brasilia /ID# 239161
Brasília, Federal District, Brazil
Hospital do Servidor Publico Municipal - Sao Paulo /ID# 239165
Niterói, Rio de Janeiro, Brazil
Universidade de Sao Paulo - Sao Paulo /ID# 239163
Rio de Janeiro, Brazil
Dermick Clinica de Dermatologia - Niteroi/Rio de Janeiro /ID# 239166
São Paulo, Brazil
Change From Baseline in the Rasch-transformed Score of the FACE-Q Satisfaction With Facial Appearance Scale.
The FACE-Q questionnaire focuses on patient's satisfaction with facial appearance at the final study visit compared to before starting study treatment and is a 10- item questionnaire. Overall scores range from 0 to 100 with higher scores representing higher satisfaction.
Time frame: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)
Change From Baseline in the FACE-Q Aging Appraisal
The FACE-Q questionnaire is a 7-item questionnaire with overall scores that range from 0 to 100 and higher scores reflecting a better outcome.
Time frame: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)
Change From Baseline in the Rasch-transformed Score of the FACE-Q Psychological Function Scale
The FACE-Q questionnaire is a 10-item questionnaire with overall scores that range from 0 to 100 and higher scores reflecting a better outcome.
Time frame: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)
Change From Baseline in the Rasch-transformed Score of the FACE-Q Social Function Scale
The FACE-Q questionnaire is a 8-item questionnaire with overall scores that range from 0 to 100 and higher scores reflecting a better outcome.
Time frame: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)
Change From Baseline in the Rasch-transformed Score of the FACE-Q Satisfaction With Skin
The FACE-Q questionnaire is a 12- item questionnaire. Overall scores range from 0 to 100 with higher scores representing higher satisfaction.
Time frame: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
HArmonyCa Lidocaine injectable gel is a dermal filler intended for facial soft tissue augmentation.
BRAVOMED Dermatology - Rio de Janeiro /ID# 239160
São Paulo, Brazil
Universidade Federal de Sao Paulo - Sao Paulo /ID# 239156
São Paulo, Brazil
Change From Baseline Self-Perception of Age
Subject's assessment of self-perception of age as measured by SPA. Subject's selected one of 3 options based on how they felt their facial appearance looked compared to their age on the day they completed the assessment, writing in the number of years when appropriate.
Time frame: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)
Investigator's Assessment Using Global Aesthetic Improvement Scale (GAIS)
Five point ordinal scale measuring the change in facial aesthetic improvement from -2 (Much Worse) to 2 (Much Improved) assessed by the Investigator.
Time frame: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)
Subject's Assessment Using Global Aesthetic Improvement Scale (GAIS)
Five point ordinal scale measuring the change in facial aesthetic improvement from -2 (Much Worse) to 2 (Much Improved) assessed by the subject.
Time frame: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)
Change From Baseline to End of Study of Periorbital Aesthetic Appearance Questionnaire (PAAQ)
Questionnaire evaluating the subject's overall eye appearance from 0 (Never) to 4 (All of the Time) for each of the 9 items. All items were transformed to a scale from 0 (no negative impact) to 100 (high negative impact). Total transformed score is based on 9 individual items each item has a range of 0 to 4, the transformed score ranges from 0 to 100. Psychological domain is based on the average of the sum of transformed scores of individual items 2, 4, 6, 7, and 8. Score will also range from 0 to 100 with same interpretation as the total transformed score. Appearance domain is based on the average of the sum of transformed scores of individual items 1, 3, and 5. Score will also range from 0 to 100 with same interpretation as the total transformed score. Coping domain is the transformed score of item 9. Score will also range from 0 to 100 with same interpretation as the total transformed score.
Time frame: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)