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Phase 4 N=59 Randomized Treatment

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

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

Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Change From Baseline in Rasch-transformed Score of FACE-Q Satisfaction With Facial Appearance Overall Scale to End of Study — 40.9; 37.8; 21.5; 32.9 score on a scale — p=0.0009

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
JUVÉDERM® (Device); BOTOX Cosmetic® (Drug); BELKYRA® (Drug); SkinMedica (Other)
Age
Adult, Older Adult · 30+ yrs
Sex
All
Sponsor
Allergan
Primary completion
Jul 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Rasch-transformed Score of FACE-Q Satisfaction With Facial Appearance Overall Scale to End of Study
40.9; 37.8; 21.5; 32.9 0.0009 sig
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
51.0; 50.1; -1.3; 4.8 0.7878
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
41.7; 40.4; 23.1; 35.6 0.0043 sig
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
57.6; 67.6; 21.3; 18.0 0.0017 sig
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
54.8; 63.1; 18.6; 15.4 0.0105 sig
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
38.5; 36.3; 21.6; 34.2 0.0004 sig
SECONDARY
Number of Participants With Participant's Assessment of Age-related Facial Appearance as Measured by Self-perception of Age (SPA) Questionnaire (Item 1)
3; 25; 2; 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
3.0; 5.0; 6.0; 2.5; 5.0; 5.5
SECONDARY
Number of Participants by Global Aesthetic Improvement Scale (GAIS) Categories as Assessed by the Investigator
11; 42; 2; 3; 0; 0
SECONDARY
Number of Participants by Global Aesthetic Improvement Scale (GAIS) Categories as Assessed by the Participant
11; 33; 2; 11; 0; 1
SECONDARY
Change From Baseline in the Periorbital Aesthetic Appearance Questionnaire (PAAQ) Total Score
55.56; 59.69; -27.56; -34.07 0.0005 sig

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.

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 sclerosi
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03712449). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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