An Interventional Study to Evaluate the Safety and Performance of Crosslinked Hyaluronic Acid Hydrogel

NCT05853224 | Unknown DMC

• 1 other identifier: CS-14-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this interventional, pre-market, double- blinded, controlled, two stages study is to evaluate the performance and safety of Crosslinked Hyaluronic Acid (CLHA) Hydrogel (with and without Lidocaine) for the Treatment of Soft Tissue Deficits.

Conditions

Dermal Filler; Volume Deficiency of the Midface

Keywords

Volume Loss, Aging, Aesthetic

Outcome Measures

Primary Outcomes (3)

• Evaluation of the CLHA performance in the nasolabial folds

  The performance of Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine), for the correction of congenital and acquired deficits of soft tissue in the Nasolabial folds, will be evaluated using the change from baseline to V3 in the Wrinkle Severity Rating Scale (WSRS) for 26 mg/ml CLHA formulation. WSRS is a validated 5-point scale (1 = Absent, 5 = Extreme)

  6 months

• Evaluation of the CLHA performance in the perioral lines

  The performance of Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine), for the correction of congenital and acquired deficits of soft tissue in the perioral lines, will be evaluated using the change from baseline to V3 in the Wrinkle Severity Rating Scale (WSRS) for 18mg/ml CLHA formulations. WSRS is a validated 5-point scale (1 = Absent, 5 = Extreme)

  6 months

• Evaluation of the CLHA performance in the lips

  The performance of Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine), for the correction of congenital and acquired deficits of soft tissue in the lips, will be evaluated using the change from baseline to V3 in the Lip Fullness Scale (LFS) for 20 mg/ml CLHA formulation. LFS is a validated 5-point scale (0 = Very Thin, 4 = Full).

  6 months

Secondary Outcomes (7)

• Evaluation of the restoring the physiological volumes of the face in the nasolabial folds

  6 months

• Evaluation of the restoring the physiological volumes of the face in the perioral lines

  6 months

• Evaluation of the restoring the physiological volumes of the face in the lips

  6 months

• Evaluation of the duration of the aesthetic effect on the nasolabial folds

  6 months

• Evaluation of the duration of the aesthetic effect on the perioral lines

  6 months

Study Arms (2)

Crosslinked Hyaluronic Acid (CLHA) Hydrogel with Lidocaine

EXPERIMENTAL

Patients were treated, on one side of the face with crosslinked Hyaluronic Acid Hydrogel with 0.3% lidocaine hydrochloride.

Device: Crosslinked Hyaluronic Acid (CLHA) Hydrogel with and without Lidocaine

Crosslinked Hyaluronic Acid (CLHA) Hydrogel without Lidocaine

EXPERIMENTAL

Patients were treated, on the other side of the face with crosslinked Hyaluronic Acid Hydrogel without lidocaine hydrochloride.

Device: Crosslinked Hyaluronic Acid (CLHA) Hydrogel with and without Lidocaine

Interventions

Crosslinked Hyaluronic Acid (CLHA) Hydrogel with and without Lidocaine DEVICE

The injection should be performed at variable depth of the skin (dermal or subdermal), depending on the area to be treated and on the product variants, in accordance to the IFU of the IPs

Crosslinked Hyaluronic Acid (CLHA) Hydrogel with Lidocaine; Crosslinked Hyaluronic Acid (CLHA) Hydrogel without Lidocaine

Eligibility Criteria

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

You may qualify if:

• Patient Informed consent form (ICF) signed
• Female and male subjects aged 18-65 years and in good general health;
• Subjects with Soft Tissue Deficits of the face requiring midface volume restoration;
• Willingness to follow all study procedures, including attending all site visits, tests, and examinations;
• Agreeing to present at each study visit without makeup;
• Accepting to not change their habits regarding food, physical activity, make-up use, facial cosmetics, and cleansing products;
• Willingness to not undergo other procedures involving permanent and nonpermanent aesthetic correction (e.g. chemical peel, dermabrasion, ablative laser resurfacing), non-invasive skin-tightening, botulinum toxin injections, dermal filler injections, mesotherapy, or fat injections during the study period of 12 months;
• Willing to follow indications to not be exposed to make-up, excessive heat (sun, UV tanning sessions, or laser), and extreme temperatures (intense cold, sauna, hammam, etc.) after the treatment and until the complete absorption of swelling and reddening.

You may not qualify if:

• Presence of recurrent facial/labial herpes;
• Presence of tendon, bone, or muscular implants near the area of intervention;
• Subjects previously treated with fillers anywhere in the face or neck;
• Subjects who have undergone invasive face or neck surgery;
• Ongoing cutaneous allergies and history of hyper- or hypo-pigmentation in the mouth area, keloid formation, or hypertrophic scarring;
• Subjects with a known allergy or sensitivity to any component of the investigation products;
• Subjects with a known allergy or sensitivity to any component of the anesthetic cream;
• Subjects with active autoimmune disease and subjects immunocompromised or immunosuppressed;
• Diabetes mellitus or uncontrolled systemic diseases (endocrine, hepatic renal, cardiac, pulmonary, neurological disorder);
• Problems with coagulation or anti-coagulating therapies in progress;
• Subjects with acute inflammatory process or infection, active herpes infection, or history of chronic or recurrent infections;
• Current treatment with substances which act on blood fluidity (eg. Aspirin, NSAIDs, Vitamin E), anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago), drugs able to influence the test results in the investigator opinion;
• Known drug and/or alcohol abuse;
• Mental incapacity that precludes adequate understanding or cooperation;
• Pregnancy or breastfeeding;

Sponsors & Collaborators

• Biopolimeri Srl: lead
• 1Med: collaborator

Study Sites (1)

Fondazione Policlinico Universitario Campus Bio-medico

Roma, 00128, Italy

RECRUITING

Study Officials

• Paolo Persichetti, Prof.

  Fondazione Policlinico Universitario Campus Bio-Medico Roma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincenzo De Benedictis, Dr.

CONTACT

3494263425; v.debenedictis@biopolimerisrl.it

Piera Angela Ramires, Dr.

CONTACT

p.ramires@biopolimerisrl.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study will be double-blinded: patients and the treating investigator will not know which variant of each product (with and without lidocaine) will be injected in the left/right side of the face (or in the upper/lower lip for CLHA Hydrogel 20 mg/ml) and the evaluating investigator will be different from the treating investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each Subject, after signing the Informed Consent (ICF), will enter into a screening phase during which the baseline tests will be conducted. At baseline visit (V0), according to the Instruction For Use (IFU) and to Investigator's judgment based on the patient's starting clinical situation, the subject will be treated with one of the three variants of Crosslinked Hyaluronic Acid (CLHA) Hydrogel as indicated below: * CLHA Hydrogel 26 mg/ml (with and without lidocaine) will be injected in the hypodermis of the nasolabial folds (NLFs); * CLHA Hydrogel 20 mg/ml (with and without lidocaine) will be injected in the lips mucosa/submucosa; * CLHA Hydrogel 18 mg/ml (with and without lidocaine) will be injected in the superficial dermis of the perioral lines.

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: May 10, 2023
• Study Start: April 2, 2022
• Primary Completion: December 2, 2023
• Study Completion: December 2, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)