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

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ClinicalTrials.gov Identifier: NCT03712449
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
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 subject's satisfaction with facial appearance from baseline to the final study visit.

Condition or disease Intervention/treatment Phase
Facial Rhytides, Skin Folds, Loss of Volume and Skin Quality Device: JUVÉDERM® Drug: BOTOX Cosmetic® Drug: BELKYRA® Other: SkinMedica Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: 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
Actual Study Start Date : January 22, 2019
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Juvéderm, BOTOX, BELKYRA, and SkinMedica

BELKYRA may be administered by injections at least 1 month apart for up to 6 treatments from V1 to V6.

From V7to V9, the subject will begin 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) and SkinMedica products (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer and Optional: Total Defence + Repair Broad Spectrum Sunscreen SPF34) to be applied daily through throughout the course of the study At V10 an 11, Subjects will receive BOTOX Cosmetic, 20U to glabellar lines (GLs) and /or 2-6U injected bilaterally to crow's feet lines (CFL) and or 24 U injected to forehead lines (FHLs)

Device: JUVÉDERM®
Subjects may receive BELKYRA treatment from visit day 1 continuing on to visit day 6 then from V7 to V9 continue to Facial filter injection (JUVÉDERM VOLBELLA with Lidocaine, and/or JUVÉDERM VOLIFT with Lidocaine, and/or JUVÉDERM VOLUMA with Lidocaine, and/or JUVÉDERM VOLITE with Lidocaine) and SkinMedica products (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer and Optional: Total Defence + Repair Broad Spectrum Sunscreen SPF34) to be applied daily through throughout the course of the study. At V10 and V11, Subjects will receive BOTOX Cosmetic, 20U to glabellar lines (GLs) and /or 2-6U injected bilaterally to crow's feet lines (CFL) and or 24 U injected to forehead lines (FHLs)

Drug: BOTOX Cosmetic®
Subjects may receive BELKYRA treatment from visit day 1 continuing on to visit day 6 then from V7 to V9 continue to Facial filter injection (JUVÉDERM VOLBELLA with Lidocaine, and/or JUVÉDERM VOLIFT with Lidocaine, and/or JUVÉDERM VOLUMA with Lidocaine, and/or JUVÉDERM VOLITE with Lidocaine) and SkinMedica products (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer and Optional: Total Defence + Repair Broad Spectrum Sunscreen SPF34) to be applied daily through throughout the course of the study. At V10 and V11, Subjects will receive BOTOX Cosmetic, 20U to glabellar lines (GLs) and /or 2-6U injected bilaterally to crow's feet lines (CFL) and or 24 U injected to forehead lines (FHLs)

Drug: BELKYRA®
Subjects may receive BELKYRA treatment from visit day 1 continuing on to visit day 6 then from V7 to V9 continue to Facial filter injection (JUVÉDERM VOLBELLA with Lidocaine, and/or JUVÉDERM VOLIFT with Lidocaine, and/or JUVÉDERM VOLUMA with Lidocaine, and/or JUVÉDERM VOLITE with Lidocaine) and SkinMedica products (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer and Optional: Total Defence + Repair Broad Spectrum Sunscreen SPF34) to be applied daily through throughout the course of the study. At V10 and V11, Subjects will receive BOTOX Cosmetic, 20U to glabellar lines (GLs) and /or 2-6U injected bilaterally to crow's feet lines (CFL) and or 24 U injected to forehead lines (FHLs)

Other: SkinMedica
Subjects may receive BELKYRA treatment from visit day 1 continuing on to visit day 6 then from V7 to V9 continue to Facial filter injection (JUVÉDERM VOLBELLA with Lidocaine, and/or JUVÉDERM VOLIFT with Lidocaine, and/or JUVÉDERM VOLUMA with Lidocaine, and/or JUVÉDERM VOLITE with Lidocaine) and SkinMedica products (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer and Optional: Total Defence + Repair Broad Spectrum Sunscreen SPF34) to be applied daily through throughout the course of the study. At V10 and V11, Subjects will receive BOTOX Cosmetic, 20U to glabellar lines (GLs) and /or 2-6U injected bilaterally to crow's feet lines (CFL) and or 24 U injected to forehead lines (FHLs)




Primary Outcome Measures :
  1. Change from baseline before treatment in the Rasch-transformed score of the FACE-Q Satisfaction with facial appearance overall scale. [ Time Frame: Baseline, Week 11 ]

Secondary Outcome Measures :
  1. Mean change from baseline in subject's assessment of expectations of life in Rasch-transformed score of the FACE-Q expectation scale aging appraisal [ Time Frame: Baseline, Week 11 ]
  2. The mean change from baseline in subject's assessment of age-related facial appearance in Rasch-transformed score of the FACE-Q [ Time Frame: Baseline, Week 11 ]
  3. Mean change from baseline in subject's assessment of psychological well-being in Rasch-transformed score of the FACE-Q psychological function scale [ Time Frame: Baseline, Week 11 ]
  4. Mean change from baseline in subject's assessment of social function in the Rasch-transformed score of the FACE-Q social function scale. [ Time Frame: Baseline, Week 11 ]
  5. Mean change subject's assessment of overall satisfaction with skin in Rasch-transformed score of FACE-Q satisfaction with skin [ Time Frame: Baseline, Week 11 ]
  6. Change from baseline in responders achieving a younger category in subject's assessment of age-related facial appearance measured by self-perception of age [ Time Frame: Baseline, Week 11 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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 subject'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. 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 subjects 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
  • Subjects with neuromuscular disorders including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise
  • Subjects with a history of allergies or hypersensitivity to HA or lidocaine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712449


Contacts
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Contact: Clinical Trials Registry Team 877‐277‐8566 IR‐CTRegistration@Allergan.com

Locations
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Canada, British Columbia
Carruthers & Humphrey Cosmetic Dermatology Recruiting
Vancouver, British Columbia, Canada, BC V5Z 4E1
Project Skin MD Vancouver Recruiting
Vancouver, British Columbia, Canada, BC V6H 1K9
Pacific Derm Recruiting
Vancouver, British Columbia, Canada, BC V6H 4E1
Canada, Ontario
Dermetics Recruiting
Burlington, Ontario, Canada, ON L7N 3N2
Dr Nowell Solish Recruiting
Toronto, Ontario, Canada, ON M5R 3N8
Bertucci MedSpa Recruiting
Woodbridge, Ontario, Canada, ON L4L 8E2
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Sara Sangha Allergan

Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03712449     History of Changes
Other Study ID Numbers: CMO-MA-FAS-0579
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Facies
Disease Attributes
Pathologic Processes
Lidocaine
Botulinum Toxins, Type A
abobotulinumtoxinA
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neuromuscular Agents
Acetylcholine Release Inhibitors
Cholinergic Agents
Neurotransmitter Agents