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HArmonyCa Injectable Gel for Midface Volume Loss
Study Summary
This trial is being conducted to assess the safety and effectiveness of HArmonyCa Lidocaine Injectable Gel for mid face soft tissue augmentation.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have had a facial injury or still have scars or deformities from one within the last 6 months.I have had semi-permanent facial fillers in the last 3 years.I have skin or mucosal infections, wounds, or lesions on my face.I currently have an eye infection or inflammation.I have had facial treatments like laser or peels in the last 6 months.I have not had botulinum toxin in my cheek or crow's feet area in the last 6 months.I am looking to get my mid-face area enhanced.I can sign and follow the study's consent form and rules.I am allergic to certain medications used in this study or similar ones.I have had facial filler injections in the last 2 years.I can and will follow the study's rules and visit schedule.I have not had major dental work in the last 6 weeks and don't plan any during the study.I haven't had any live vaccines in the last 4 weeks and don't plan to during the study.I am willing to remove any facial hair, piercings, or cover tattoos for assessments.
- Group 1: HArmonyCa Lidocaine Injectable Gel
- Group 2: Control Group
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does the use of HarmonyCa Lidocaine Injectable Gel carry any risks?
"There is both efficacy and safety data available for HArmonyCa Lidocaine Injectable Gel, so it received a score of 3."
Does this research have a wide geographic scope?
"There are 8 clinical trial sites that are actively recruiting patients, including Humphrey Cosmetic Dermatology in Burlington, Pacific Derm in Woodbridge, and Skin Matters Medical Aesthetic Centre in Oakville."
What is the aim of this research?
"The purpose of this study, which will last for 3 months, is to monitor the number of participants that experience adverse events. Additionally, the study will also track secondary outcomes like percentage of patients that see global aesthetic improvement on a 5-point scale and satisfaction with cheeks and lower face jawline pre and post treatment."
Can new patients still join this investigation?
"That is accurate, the clinical trial in question is detailed on clinicaltrials.gov and is currently recruiting participants. The 160 potential subjects are needed from 8 different locations, with the original posting date being September 7th, 2022."
How many people are in this trial?
"That is correct. The information available on clinicaltrials.gov confirms that this study, which was first posted on September 7th, 2020, is actively seeking patients. This particular trial is looking to recruit 160 patients from 8 different locations."
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