Volume Deficiency of the Midface Clinical Trial
— RESOfficial title:
A Randomized, Split-face Clinical Study on Comparative Ultrasound Analysis of Two Hyaluronic Acid Fillers for Midface Correction
Verified date | October 2022 |
Source | Galderma R&D |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To assess and compare tissue aggregation and visualization of two Hyaluronic Acid fillers via ultrasound
Status | Completed |
Enrollment | 11 |
Est. completion date | December 6, 2023 |
Est. primary completion date | September 25, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 22 Years to 65 Years |
Eligibility | Inclusion Criteria: - Subject with midface volume loss and contour deficiency - Ability of giving consent for participation in the study - Agreement to adhere to the procedures and requirements of the study and to report to the institute on the day(s) and at the time(s) scheduled for the assessments Exclusion Criteria: - History of allergy or hypersensitivity to lidocaine and/or injectable hyaluronic acid - Previous permanent or semi-permanent implant in proposed treatment area - Previous biodegradable tissue augmentation therapy in the proposed treatment area within 12 months prior to the baseline visit - History of other facial treatment/procedure at the study area (midface) in the previous 6 months that would potentially interfere with study injections (e.g., facial surgery, oral surgery, resurfacing, mesotherapy, lipolytic injections, botulinum toxin injections) |
Country | Name | City | State |
---|---|---|---|
United States | The Aesthetic Clinique | Santa Rosa Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Galderma R&D |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assess and compare tissue aggregation and visualization of Hyaluronic Acid fillers using ultrasound | Change in filler properties within the skin tissues. Filler properties include size, shape, and aggregation at different facial expressions. | Immediately post-treatment, 4 weeks, 6 months, 9 months, and 12 months after baseline | |
Secondary | Evaluate subject satisfaction using self-assessment questionnaire | Percentage of response at 4 weeks, 6 months, 9 months, and 12 months, where subjects are asked about their satisfaction with treatment outcome on the midface. Scale consists of 3 preference questions (with no difference option) and 6 satisfaction questions (with strongly agree, agree, neutral, disagree, and strongly disagree). | 4 weeks, 6 months, 9 months, and 12 months after baseline | |
Secondary | Evaluate volume change in the treated areas using 3D imaging | Summary of total volume change in the midface measured by digital 3D photography at each visit. Total volume change corresponds to net volume change from baseline in the treated area. | 4 weeks, 6 months, 9 months, and 12 months after baseline |
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