The cumulative effect of aging and environmental exposures (ie, ultraviolet, infrared, and visible light radiation and pollution) leads to wrinkles, discoloration, laxity, and roughness of sun exposed skin. The rapid restoration of soft tissue augmentation is commonly achieved by the use of dermal fillers. HArmonyCa Lidocaine injectable gel is a dermal filler intended for facial soft tissue augmentation. The purpose of this study is to assess adverse events and effectiveness of HArmonyCa Lidocaine injectable gel in adults seeking mid face soft tissue augmentation. HArmonyCa Lidocaine Injectable Gel is an investigational device being developed for soft tissue augmentation in the mid face. Participants are placed in 1 of 2 groups, called treatment arms. There is a 1 in 3 chance that participants will be assigned to the control group. Around 160 adult participants seeking soft tissue augmentation will be enrolled in the study at approximately 15 sites worldwide. Participants in the treatment group will receive HArmonyCa Lidocaine injectable gel at Day 1 and followed for up to 25 Months. Participants will have the opportunity to receive optional touch-up and optional repeat treatment of HArmonyCa Lidocaine injectable gel during the follow-up duration period. Participants in the control group are followed for 3 months and then can opt to receive HArmonyCa Lidocaine Injectable Gel at the end of month 3. The control group will participate in the study for up to 25 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
171
Subdermal or deep dermal injection
YVR Aesthetics Training & Study Centre /ID# 239809
Vancouver, British Columbia, Canada
Humphrey & Beleznay Cosmetic Dermatology /ID# 239805
Vancouver, British Columbia, Canada
Pacific Derm /ID# 240785
Vancouver, British Columbia, Canada
Skin Matters Medical Aesthetic Centre /ID# 239986
Vancouver, British Columbia, Canada
Dermetics Cosmetic Dermatology /ID# 246536
Burlington, Ontario, Canada
The Centre for Clinical Trials /ID# 246409
Oakville, Ontario, Canada
Bertucci MedSpa Inc. /ID# 246496
Woodbridge, Ontario, Canada
Erevna Innovations Inc. /ID# 240401
Westmount, Quebec, Canada
Instituto Medico Miramar /ID# 240939
Málaga, Malaga, Spain
WM Hospitals /ID# 245747
Barcelona, Spain
...and 2 more locations
Percentage of Participants Achieving "Responder" Status for Evaluating Investigator's (EI) live assessment of Mid Face Volume Deficit Scale (MFVDS)
A "responder" is a participant with at least 1- grade improvement (reduction) of mid face soft tissue deficit using the MFVDS. MFVDS is a validated 6-point scale (0 = None, 5 = Severe).
Time frame: Month 3
Number of Participants with Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
Time frame: Up to 25 Months
Percentage of Participants Achieving "Responder" Status for EI's Live Assessment of Global Aesthetic Improvement Scale (GAIS).
A "responder" is a participant who achieves improved or much improved on GAIS. GAIS is a 5-point scale used to assess global aesthetic improvement of the cheek area (2=Much Improved, -2=Much Worse).
Time frame: Month 3
Percentage of Participants Achieving "Responder" Status for Participant Assessment of Global Aesthetic Improvement Scale (GAIS).
A "responder" is a participant who achieves improved or much improved on GAIS. GAIS is a 5-point scale used to assess global aesthetic improvement of the cheek area (2=Much Improved, -2=Much Worse).
Time frame: Month 3
Change from baseline on overall score in FACE-Q Satisfaction with cheeks specific questionnaire
In the FACE-Q Satisfaction with Cheeks questionnaire, the responses will be summed and converted to a Rasch-transformed score that ranges from 0 to 100.
Time frame: Month 3
Change from baseline on overall score in FACE-Q Satisfaction with lower face and jawline specific questionnaire
In the FACE-Q Satisfaction with lower face and jawline specific questionnaire, the responses will be summed and converted to a Rasch-transformed score that ranges from 0 to 100.
Time frame: Month 3
Change from baseline on overall score in FACE-Q Satisfaction with appearance specific questionnaire
In the FACE-Q Satisfaction with appearance specific questionnaire, the responses will be summed and converted to a Rasch-transformed score that ranges from 0 to 100.
Time frame: Month 3
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