Clinical trial NCT03712449: A Study to Evaluate Participant Satisfaction With Facial Appearance Overall and the Aesthetic and Psychosocial Impact of Combined Facial Treatment
Official title: Canada Global HARMONY: Prospective, Multi-site, Study to Evaluate Subject Satisfaction With Facial Appearance Overall and the Aesthetic and Psychosocial Impact of Combined Facial Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Facial Rhytides, Skin Folds, Loss of Volume and Skin Quality
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2018-10-19
Enrollment: 59
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in Rasch-transformed Score of FACE-Q Satisfaction With Facial Appearance Overall Scale to End of Study
timeFrame: Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
Secondary outcomes:
measure: 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
timeFrame: Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
measure: 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
timeFrame: Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
measure: 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
timeFrame: Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
measure: 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
timeFrame: Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
measure: 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
timeFrame: Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
measure: Number of Participants With Participant's Assessment of Age-related Facial Appearance as Measured by Self-perception of Age (SPA) Questionnaire (Item 1)
timeFrame: Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
measure: 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
timeFrame: Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
measure: Number of Participants by Global Aesthetic Improvement Scale (GAIS) Categories as Assessed by the Investigator
timeFrame: Baseline (Prior to Treatment) to the End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
measure: Number of Participants by Global Aesthetic Improvement Scale (GAIS) Categories as Assessed by the Participant
timeFrame: Baseline (Prior to Treatment) to the End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
measure: Change From Baseline in the Periorbital Aesthetic Appearance Questionnaire (PAAQ) Total Score
timeFrame: Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Carruthers & Humphrey Cosmetic Dermatology
state: British Columbia
city: Vancouver
country: Canada
facility: Shannon Humphrey
state: British Columbia
city: Vancouver
country: Canada
facility: Project Skin MD Vancouver
state: British Columbia
city: Vancouver
country: Canada
facility: Pacific Derm
state: British Columbia
city: Burlington
country: Canada
facility: Dermetics
state: Ontario
city: Toronto
country: Canada
facility: Dr Nowell Solish
state: Ontario
city: Woodbridge
country: Canada
facility: Bertucci MedSpa
state: Ontario
Study officials:
affiliation: Allergan
name: Sara Sangha
role: STUDY_DIRECTOR
References: