A Prospective, Randomized, Double-blinded, Controlled, Split-face, Non-inferiority Clinical Investigation Comparing the Safety and Performance of RefillHA Solid With Hydryalix Ultra Deep Lidocaine for the Correction of Moderate-to-severe Nasolabial Folds.

NCT07736703 | Completed

• 1 other identifier: HA25L-01-24
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, controlled, randomized, monocentric, double-blind, split-face non-inferiority clinical study to evaluate the safety and performance of injectable implant based on hyaluronic acid hydrogel with lidocaine for correction of moderate-to-severe nasolabial folds

Conditions

Wrinkles and Folds

Keywords

Wrinkles; Folds

Outcome Measures

Primary Outcomes (1)

• Primary effectiveness endpoint

  Based on primary outcome - WSRS improvement difference between treatment groups at week 24. The improvement in WSRS will be analyzed by a non-inferiority statistical model with a 0.5 margin for the difference between treatment groups.

  [Time Frame: Up to 56 weeks after treatment]

Study Arms (1)

Subjects over the age of 18, seeking correction of moderate to severe nasolabial folds.

Eligibility Criteria

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

Study Population

Subjects over the age of 18, seeking correction of moderate to severe nasolabial folds.

You may qualify if:

• Men or women of any race, 18 years of age or older.
• The presence of moderate to severe bilateral NLFs each with WSRS score of 3 or 4.
• NLFs of the same WSRS grade on the left and right sides of the face.
• Willing and able to read, understand and sign the informed consent.
• Willing to adhere to the protocol and to comply with the requirements of the entire investigation (ability to attend all the planned investigation visits according to the time limits included and report events and concomitant medication for the entire duration of investigation).
• Agree not to undergo other treatments or cosmetic procedures in the treatment area during the study, such as botulinum toxin, hyaluronic acid injections, facial laser treatments, fat injections, any other permanent or semi-permanent facial dermal fillers.
• Female subjects of childbearing potential must have a negative urine pregnancy test and must adopt an appropriate method of contraception for the entire duration of investigation.

You may not qualify if:

• Pregnant (as determined by a urine pregnancy test at the screening visit) or lactating women.
• Prior treatment (i.e., other permanent or biodegradable injectable fillers or surgical correction such as a face-lift, etc.) within 3 months prior to entry into the study or planned to undergo such treatment during the study.
• Previous treatment with permanent implants (e.g., silicone) in the area to be treated.
• Subjects who are currently or recently treated with laser, ultrasound or peeling, and who have not fully recovered from these treatments.
• Presence of active inflammation, infection, or unhealed wound of the face, such as acne, herpes, dermatitis, scaring etc.
• Presence of varices in the area to be treated.
• History of hypertrophic scarring.
• Metabolic or endocrine serious diseases (e.g., uncontrolled diabetes or diabetes complications), anaphylaxis, severe allergies, immune disorders affecting the skin or other local or systemic concomitant diseases that may interfere with healing.
• Current neoplastic (including skin cancer) and/or immunodepressive diseases.
• Known hypocoagulability state.
• Have received anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti- inflammatory drugs (NSAIDs such as aspirin, ibuprofen), or other substances known to prolong time of coagulation from a week before treatment. A wash-out period of a week is allowed.
• Use of narcotic agents, antineoplastics, immunosuppressants or any other agent that may interfere with wound healing in the months before the screening visit.
• History of severe allergic/anaphylactic reactions or multiple allergies.
• Subject, who has a condition or is in a situation that, in the investigator's opinion, may put the subject at significant risk, or may significantly interfere with the patient's participation in the study or with protocol evaluation parameters.
• Subjects considered to be unsuitable to participate, in the investigator's opinion, for any other reason.

Sponsors & Collaborators

• Glyance: lead

Study Sites (1)

Glyance Ltd

Lod, Israel, 7152026, Israel

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: July 30, 2026
• Study Start: December 8, 2024
• Primary Completion: January 25, 2026
• Study Completion: January 25, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

IL (1)