Hyaluronic Acid Filler Migration

NCT07079397 | Recruiting

• 1 other identifier: GAL-2025-MIG-67
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Soft tissue filler injections continue to grow in popularity as a method of facial rejuvenation, including volume restoration and contour enhancement. Many different hyaluronic acid (HA)-based fillers are available on the market and differ in terms of their physical and chemical properties, which results in families of fillers (e.g., Non-Animal Stabilized Hyaluronic Acid - NASHA vs. Optimal Balance Technology - OBT) with different tissue integration patterns. It has been proposed that the properties of fillers significantly influences their tendency to migrate. More specifically, thick fillers may be less prone to migration compared to fluid fillers. However, a detailed knowledge of facial anatomy, safer injection techniques, and careful product selection based on filler qualities may be preventive measures for filler migration. The goal of this study is to describe the short and intermediate-term product distribution/integration patterns of NASHA and OBT-based fillers, and to evaluate the evidence (if any) of filler migration from the intended site of injection.

Conditions

Aesthetic

Keywords

Hyaluronic Acid; Fillers; Facial Assessment; Migraion

Outcome Measures

Primary Outcomes (1)

• Evaluate evidence (if any) of filler migration from the intended site of injection for NASHA and OBT-based fillers, as visualized by high resolution MRI.

  High resolution MRI will determine presence of filler migration. Migration will be assessed radiologically and defined as the presence of identifiable product in anatomical regions outside the treatment area (where the product was initially placed) using a dichotomous qualitative response "yes/no".

  Baseline (post optimal correction), Week 12 and Week 24

Secondary Outcomes (2)

• Number of particpants assessed as having proudct distribution past the area of injection. Assesment will be determined clincially by a qualified physician.

  Baseline (post optimal correction), Week 12 and Week 24

• Number of particpants assessed as having proudct distribution past the area of injection. Assesment will be made uisng ultrasoundimaging

  Baseline (post optimal correction), Week 12 and Week 24

Other Outcomes (1)

• Evaluate the frequncy of advese events (safety) of pan-facial HA injections.

  Baseline to Week 24

Study Arms (1)

Restylane Injectables

OTHER

All adult participants (\>18 years)

Device: Restylane Injectables

Interventions

Restylane Injectables DEVICE

Participants will receive pan-facial treatment in at least one facial area using a Restylane NASHA product and at least one different facial area using Restylane OBT product. Participants will undergo three (3) scheduled MRI scans thoughout the duration of the study post HA injections.

Restylane Injectables

Eligibility Criteria

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

You may qualify if:

• At the time of consent, male or female participants 18 years of age and older;
• Participants with established facial volume loss and/or contour deficits;
• Accepted the obligation not to receive any other facial procedures throughout the study duration;
• Understood and accepted the obligation and would be logistically able to appear for all scheduled follow-up visits;
• No previous facial fillers for 18 months prior to this study;
• Capable of providing informed consent, approved by an independent ethics committee, prior to the initiation of any screening or study-specific procedures;
• Participants must be willing and able to comply with procedures required in the protocol.
• Participants must be in good health as per investigator's judgment based on medical. history.
• Female participants of childbearing potential must be willing practice at least 1 protocol-specified method of birth control that is effective from Baseline through at least 30 days after the last dose or until the end of study, whichever is longer. Female participants of non-childbearing potential do not need to use birth control

You may not qualify if:

• Current Pregnancy or lactation \[sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)\];
• Hypersensitivity to Restylane products, HA filler or amide local anesthetics;
• Participants presenting with porphyria or any other liver diseases;
• Inability to comply with follow-up and abstain from facial injections during the study period;
• Heavy smokers, classified as smoking more than 12 cigarettes per day;
• History of severe or multiple allergies manifested by anaphylaxis, since drug allergies might preclude optimal management of complications;
• Previous tissue revitalization therapy in the treatment area within 6 months before treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling, or dermabrasion;
• Previous facial surgery, including liposuction;
• Lifetime history of permanent implants in the treatment region;
• History in the last 18 months of semi-permanent dermal fillers (e.g., poly-L-lactic acid, polyalkylimide, polymethylmethacrylate, polytetrafluoroethylene, and silicone), synthetic implantation and/or autologous fat transplantation in the treatment region;
• History or presence of any disease or lesion near or at the treatment area, including inflammation, active or chronic infection, including in the mouth, dentals, head and neck region;
• Participant has an uncontrolled systemic diseases
• Participants present with or have a history of any medical condition that may place the participant at increased risk following exposure to hyaluronic acid or interfere with the study evaluation, including:
• Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function
• History of facial nerve palsy

Sponsors & Collaborators

• Erevna Innovations Inc.: lead

Study Sites (1)

Erevna Innovations Inc.

Westmount, Quebec, H3Z 1C3, Canada

RECRUITING

Study Officials

• Andreas Nikolis, MD

  Erevan Innovations Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Raco

CONTACT

514-488-0163; lraco@vicpark.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: July 23, 2025
• Study Start: December 11, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)