Facial Rhytides, Skin Folds, Loss of Volume and Skin QualityPhase 4NCT03712449
A Study to Evaluate Participant Satisfaction With Facial Appearance Overall and the Aesthetic and Psychosocial Impact of Combined Facial Treatment
A Phase 4 study testing JUVÉDERM®, BOTOX Cosmetic® and BELKYRA® in people with Facial Rhytides, Skin Folds, Loss of Volume and Skin Quality, run by Allergan at 7 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Facial Rhytides, Skin Folds, Loss of Volume and Skin Quality
- What is being tested?
- JUVÉDERM®, BOTOX Cosmetic® and BELKYRA®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 7 sitesCanada
- Study dates
- 22 Jan 2019to 29 Jul 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 30Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
Dermetics
Burlington, Ontario, ON L7N 3N2
Dr Nowell Solish
Toronto, Ontario, ON M5R 3N8
Carruthers & Humphrey Cosmetic Dermatology
Vancouver, British Columbia, BC V5Z 4E1
Shannon Humphrey
Vancouver, British Columbia, BC V5Z 4E1
Project Skin MD Vancouver
Vancouver, British Columbia, BC V6H 1K9
Pacific Derm
Vancouver, British Columbia, BC V6H 4E1
Bertucci MedSpa
Woodbridge, Ontario, ON L4L 8E2
About this study
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
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.
- Being tested
- JUVÉDERM®, BOTOX Cosmetic®, BELKYRA®, SkinMedica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JUVÉDERM®Device
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) from Month 6 to Month 8 (BELKYRA Treatment) and Month 0 to Month 2 (Non-BELKYRA Treatment).
BOTOX Cosmetic®Drug
BOTOX Cosmetic, 20 U to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U injected to forehead lines at Month 9 and Month 10 (BELKYRA Treatment) and at Month 3 and Month 4 (Non-BELKYRA Treatment).
BELKYRA®Drug
BELKYRA, subcutaneous injection for maximum of 6 treatments, 1 month apart from Month 0 to Month 5. Maximum dose = 100 mg (10mL).
SkinMedicaOther
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 (BELKYRA Treatment) and Month 0 to Month 5 (Non-BELKYRA Treatment).
| Study group | Role | What they receive |
|---|---|---|
| BELKYRA Treatment | Experimental | 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. Receives: Device: JUVÉDERM®; Drug: BOTOX Cosmetic®; Drug: BELKYRA®; Other: SkinMedica |
| Non-BELKYRA Treatment | Experimental | 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. Receives: Device: JUVÉDERM®; Drug: BOTOX Cosmetic®; Other: SkinMedica |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Rasch-transformed Score of FACE-Q Satisfaction With Facial Appearance Overall Scale to End of Study
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.
Measured: Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
Secondary outcomes (10)
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
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.
Measured: Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
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
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.
Measured: Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
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
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.
Measured: Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
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
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.
Measured: Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
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
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.
Measured: Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
Number of Participants With Participant's Assessment of Age-related Facial Appearance as Measured by Self-perception of Age (SPA) Questionnaire (Item 1)
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.
Measured: Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
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
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.
Measured: Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
Number of Participants by Global Aesthetic Improvement Scale (GAIS) Categories as Assessed by the Investigator
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.
Measured: Baseline (Prior to Treatment) to the End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
Number of Participants by Global Aesthetic Improvement Scale (GAIS) Categories as Assessed by the Participant
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.
Measured: Baseline (Prior to Treatment) to the End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
Change From Baseline in the Periorbital Aesthetic Appearance Questionnaire (PAAQ) Total Score
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.
Measured: Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start22 Jan 2019
- Primary completion29 Jul 2020
- Study completion29 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Facial Rhytides, Skin Folds, Loss of Volume and Skin QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sara Sangha, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712449
- Sponsor's protocol ID
- CMO-MA-FAS-0579
- Status last verified
- Oct 2023
- First submitted
- 17 Oct 2018
- Last updated
- 31 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03712449
- Acronym / sponsor ID
- CMO-MA-FAS-0579
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 29 Jul 2020 (actual)
- Study completion
- 29 Jul 2020 (actual)
- First posted
- 19 Oct 2018 (actual)
- Results
- Posted 25 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BELKYRA Treatment | Experimental | Device: JUVÉDERM®, Drug: BOTOX Cosmetic®, Drug: BELKYRA®, Other: SkinMedicaBELKYRA 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 | Experimental | Device: JUVÉDERM®, Drug: BOTOX Cosmetic®, Other: SkinMedicaParticipants 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JUVÉDERM®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) from Month 6 to Month 8 (BELKYRA Treatment) and Month 0 to Month 2 (Non-BELKYRA Treatment). | Device | BELKYRA Treatment, Non-BELKYRA Treatment |
| BOTOX Cosmetic®BOTOX Cosmetic, 20 U to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U injected to forehead lines at Month 9 and Month 10 (BELKYRA Treatment) and at Month 3 and Month 4 (Non-BELKYRA Treatment). | Drug | BELKYRA Treatment, Non-BELKYRA Treatment |
| BELKYRA®BELKYRA, subcutaneous injection for maximum of 6 treatments, 1 month apart from Month 0 to Month 5. Maximum dose = 100 mg (10mL). | Drug | BELKYRA Treatment |
| SkinMedicaSkinMedica products (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 6 to Month 11 (BELKYRA Treatment) and Month 0 to Month 5 (Non-BELKYRA Treatment). | Other | BELKYRA Treatment, Non-BELKYRA Treatment |
Primary outcome
Change From Baseline in Rasch-transformed Score of FACE-Q Satisfaction With Facial Appearance Overall Scale to End of Study
Time frame: 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.
10 secondary outcomes
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
Time frame: Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
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
Time frame: Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
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
Time frame: Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
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
Time frame: Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
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
Time frame: Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
Number of Participants With Participant's Assessment of Age-related Facial Appearance as Measured by Self-perception of Age (SPA) Questionnaire (Item 1)
Time frame: Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
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
Time frame: Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
Number of Participants by Global Aesthetic Improvement Scale (GAIS) Categories as Assessed by the Investigator
Time frame: Baseline (Prior to Treatment) to the End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
Number of Participants by Global Aesthetic Improvement Scale (GAIS) Categories as Assessed by the Participant
Time frame: Baseline (Prior to Treatment) to the End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
Change From Baseline in the Periorbital Aesthetic Appearance Questionnaire (PAAQ) Total Score
Time frame: Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Sangha study director
Allergan
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing JUVÉDERM®, BOTOX Cosmetic® and BELKYRA® in people with Facial Rhytides, Skin Folds, Loss of Volume and Skin Quality, run by Allergan at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Rasch-transformed Score of FACE-Q Satisfaction With Facial Appearance Overall Scale to End of Study (time frame: Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.