A Study to Evaluate the Safety and Efficacy of Revanesse Shape + With Lidocaine Versus Juvederm V… (NCT04927052) | Clinical Trial Compass
CompletedNot Applicable
A Study to Evaluate the Safety and Efficacy of Revanesse Shape + With Lidocaine Versus Juvederm Voluma With Lidocaine for the Correction of Age-Related Midface Volume Deficit / Lipoatrophy at 6 and 12 Months Post-treatment
Canada136 participantsStarted 2021-04-21
Plain-language summary
To compare the safety and efficacy profiles of Revanesse Shape + with Lidocaine versus Juvederm Voluma with Lidocaine for subcutaneous and/or supraperiosteal injection to improve appearance through the correction of age-related mid-face volume deficit in patients 22 years of age through 65 years of age.
Midface volume deficit / lipoatrophy (loss of subcutaneous adipose tissue that is most apparent in the face) may be associated with acquired conditions, the aging process, or based on genetic causes.
Who can participate
Age range22 Years – 65 Years
SexALL
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Inclusion criteria
✓. Men or non-pregnant, non-breastfeeding women 22 years of age through 65 years of age.
✓. Subjects seeking augmentation therapy for the mid-face with a MMVS score of 3 (moderate loss of fullness with slight hollowing) or 4 (substantial loss of fullness in the mid-face area, clearly apparent hollowing) on each side of the face as independently assessed by the blinded Evaluating Investigator and the unblinded Treating Investigator
✓. If female and of childbearing potential, a negative urine pregnancy test at Baseline (Day 1) and the subject agrees to use adequate contraception during the study period.
✓. Ability to understand and comply with the requirements of the study.
✓. Willingness and ability to provide written informed consent.
✓. Willing to abstain from any other facial procedures or treatments affecting facial volume deficit at any time during the study
Exclusion criteria
✕. MMVS score of 1 (fairly full) or 2 (mild loss of fullness) on either side of the face.
✕
What they're measuring
1
Change from baseline to Visit 6/Month 6 in the Medicis Mid-face Volume Scale (MMVS) score
. Women who are pregnant or lactating or anticipate becoming pregnant during the study period.
✕. Have ever undergone facial plastic surgery (with the exception of rhinoplasty more than 2 years prior to enrollment), tissue grafting, or tissue augmentation with silicone, fat, or other permanent (Ex: polymethylmethacrylate (Bellafill)), or semi-permanent dermal fillers (Ex: calcium hydroxylapatite (Radiesse®)) or planning to undergo any of these procedures at any time during the study.
✕. Have undergone temporary facial dermal filler injections with hyaluronic acid-based fillers within 12 months, porcine-based collagen fillers within 12 months, or neuromodulator injections, mesotherapy, or resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, microneedling or other ablative or non-ablative procedures) within 6 months on the face or neck prior to study entry or planning to undergo any of these procedures at any time during the study.
✕. History of use of threads below the lower orbital rim within the preceding 6 months or planning their use at any time during the study
✕. History of use of injectable deoxycholate (Kybella®) anywhere on the face or neck within preceding 6 months or planning to undergo treatment at any time during the study
✕. Evidence of scar-related disease or delayed healing activity to the mid-face within the past 1 year.
✕. Has acute or chronic skin disease or scars at the intended treatment sites.