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

NCT04927052 | Completed

• 1 other identifier: PRO 2019-04 CAN
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Volume Deficit in the Mid-face

Outcome Measures

Primary Outcomes (1)

• Change from baseline to Visit 6/Month 6 in the Medicis Mid-face Volume Scale (MMVS) score

  The blinded evaluating investigator assessed the participant's overall mid-face volume deficit for each cheek using a 4-point photonumeric scale, where: 1=None (fairly full midface) \[best\] to 4=Substantial (substantial loss of fullness in the mid-face area) \[worst\]. A negative change from Baseline indicates improvement

  Baseline visit to Visit 6/Month 6.

Secondary Outcomes (5)

• Change from baseline to Visit 7/Month 12 in the Medicis Mid-face Volume Scale (MMVS) score

  Baseline visit to Visit 7/Month 12

• Change in the Nasolabial Folds Wrinkle Severity Rating Scale score at Visit 2/Week 2, Visit 3/Month 1, Visit 4/Month 2, Visit 5/Month 3, Visit 6/Month 6, Visit 7/Month 12 and Visit 8/Month 15

  Visit 2/Week 2, Visit 3/Month 1, Visit 4/Month 2, Visit 5/Month 3, Visit 6/Month 6, Visit 7/Month 12 and Visit 8/Month 15

• Percent of subjects with clinical success at Visit 6/Month 6 where success is defined as a subject with at least a 1-grade improvement from baseline on the Investigator Global Aesthetic Improvement Score (iGAIS).

  Baseline visit to Visit 6/Month 6

• Percent of subjects with treatment success at Visit 6/Month 6 where success is defined as a subject with at least a 1-grade improvement from baseline on the Patient Global Aesthetic Improvement Score (pGAIS)

  Baseline to Visit 6/Month 6

• Percent of subjects with treatment success at Visit 7/Month 12 where success is defined as a subject with at least a 1-grade improvement from baseline on the Patient Global Aesthetic Improvement Score (pGAIS)

  Baseline to Visit 7/Month 12

Other Outcomes (9)

• Subject overall satisfaction of facial appearance for each side of the face

  Baseline to Visit 2/Week 2, Visit 3/Month 1, Visit 4/Month 2, Visit 5/Month 3, Visit 6/Month 6, Visit 7/Month 12 and Visit 8/Month 15and every study visit

• Subject satisfaction with mid-facial region for each side of the face

  Baseline to Visit 2/Week 2, Visit 3/Month 1, Visit 4/Month 2, Visit 5/Month 3, Visit 6/Month 6, Visit 7/Month 12 and Visit 8/Month 15

• Subject look of mid-face for each side of the face

  Baseline to Visit 2/Week 2, Visit 3/Month 1, Visit 4/Month 2, Visit 5/Month 3, Visit 6/Month 6, Visit 7/Month 12 and Visit 8/Month 15

Study Arms (2)

Revanesse Shape + with Lidocaine

ACTIVE COMPARATOR

Revanesse Shape + with Lidocaine is a clear, colorless gel in 1.2 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w. Participants had 1 cheek treated with Revanesse Shape + with Lidocaine

Device: Revanesse Shape + with Lidocaine; Device: Juvederm Voluma with Lidocaine.

Juvederm Voluma with Lidocaine

ACTIVE COMPARATOR

Juvederm Voluma with Lidocaine is a clear, colorless gel in 1.0 mL pre-filled syringes formulated to a concentration of 20 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w. Participants had 1 cheek treated with Juvederm Voluma with Lidocaine.

Device: Revanesse Shape + with Lidocaine; Device: Juvederm Voluma with Lidocaine.

Interventions

Revanesse Shape + with Lidocaine DEVICE

Revanesse Shape + with Lidocaine. Participants had 1 cheek treated with Revanesse Shape + with Lidocaine

Juvederm Voluma with Lidocaine; Revanesse Shape + with Lidocaine

Juvederm Voluma with Lidocaine. DEVICE

Juvederm Voluma with Lidocaine. Participants had 1 cheek treated with Juvederm Voluma with Lidocaine

Juvederm Voluma with Lidocaine; Revanesse Shape + with Lidocaine

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• MMVS score of 1 (fairly full) or 2 (mild loss of fullness) on either side of the face.
• 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.
• History of keloid formation or hypertrophic scars.
• History or the presence of any disease that may result in changes in facial contour or edema of the face during the course of the study, (e.g., inflammation, infection, facial psoriasis, herpes zoster, acanthosis, cancer, pre-cancer, actinic keratosis, etc.)
• Presence of active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection on the face.
• Is on an ongoing regimen of anticoagulation therapy (e.g., warfarin), thrombolytics, or inhibitors of platelet aggregation
• Nonsteroidal anti inflammatory drugs (NSAIDs, e.g., aspirin, ibuprofen) or other substances known to increase coagulation time (e.g., herbal supplements with garlic or gingko) within 10 days of undergoing study device injections. Subjects who will withhold such therapy for 10 days before AND after any injection session may participate.
• Prescription, oral or topical anti-wrinkle products in the treatment area within 90 days prior to treatment and throughout the study. (Use of sunscreens and continued therapy with OTC topical treatments (e.g., alpha hydroxyl acids, glycolic acids, retinoids) are allowed if regimen was established ≥ 90 days prior to treatment).
• History of allergy, anaphylaxis or hypersensitivity to injectable hyaluronic acid products, local anesthetics of the amide type such as lidocaine, or gram positive bacterial proteins or is planning to undergo desensitization therapy during the study.

Sponsors & Collaborators

• Prollenium Medical Technologies Inc.: lead

Study Sites (7)

Laser Rejuvenation

Calgary, Alberta, T2W 4X9, Canada

Location

Alpha Research/Lucere Dermatology

Edmonton, Alberta, T6X 0N9, Canada

Location

Dermetics

Burlington, Ontario, L7N 3N2, Canada

Location

The Centre for Clinical Trials

Oakville, Ontario, L6J 7W5, Canada

Location

Bertucci MedSpa

Woodbridge, Ontario, L4L 8E2, Canada

Location

Victoria Park Medispa Laval

Laval, Quebec, H7S 1M9, Canada

Location

Erevna Innovations

Westmount, Quebec, H3Z 1C3, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Additionally, the Sponsor's staff conducting the study, and members of the administrative team will not have access to individual subjects' treatment assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A split-face study in subjects seeking to correct mid-face volume deficit. Subjects will be treated with Revanesse Shape + with Lidocaine on one side of the face and Juvederm Voluma with Lidocaine on the other side of the face. The side of the face for each device will be randomly assigned.

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 15, 2021
• Study Start: April 21, 2021
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)