Clinical Study on Hyaluronic Acid With Lidocaine for the Treatment of Moderate to Severe Nasolabial Folds

NCT05252325 | Unknown

• 1 other identifier: HA28L/MD01/20
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

This will be a pre-CE mark controlled, prospective, randomized, blinded evaluator, single centre, split-face clinical investigation. Each subject will receive both medical devices under investigation, one (HAL: Hyaluronic Acid plus Lidocaine ) on the one side of the face, the other (HA: Hyaluronic Acid) on the other side, in randomized fashion.

Conditions

Nasolabial Folds

Outcome Measures

Primary Outcomes (1)

• changes in pain due to the injection assessed by VAS (Visual Analogue Scale, 0-100 mm) at 15-30-45-60 minutes after each injection(baseline)

  pain experienced by subjects during and immediately after injections of the products under investigation \[hyaluronic acid PEG-cross-linked formulated with 0.3% lidocaine: HAL\] versus the same product WITHOUT lidocaine \[HA\], separately for each side of the face. Higher scores mean a worse outcome.

  within 1 min and 15-30-45-60 minutes after each injection

Secondary Outcomes (3)

• Clinical efficacy

  done by the subject at weeks 2, 12 and 24 after treatments, separately for each side of the face

• Clinical efficacy

  done by the blind evaluator before intervention and 12-24 weeks after injections, separately for each side of the face

• Clinical efficacy

  done by the blind evaluator and by the the subject at the week 24 of the study, separately for each side of the face

Study Arms (2)

HAL on the right side of the face; HA on the left side of the face

OTHER

the subjects will receive HAL ( hyaluronic acid +lidocaine)in the right side of the face, HA (hyaluronic acid without lidocaine) in the left side

Device: hyaluronic acid plus lidocaine; Device: hyaluronic acid without lidocaine

HAL on the left side of the face; HA on the right side

OTHER

the subjects will receive HA in the right side of the face, HAL in the left side

Device: hyaluronic acid plus lidocaine; Device: hyaluronic acid without lidocaine

Interventions

hyaluronic acid plus lidocaine DEVICE

local injection for correction of nasolabials fold

HAL on the left side of the face; HA on the right side; HAL on the right side of the face; HA on the left side of the face

hyaluronic acid without lidocaine DEVICE

local injection for correction of nasolabial folds

HAL on the left side of the face; HA on the right side; HAL on the right side of the face; HA on the left side of the face

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of moderate to severe nasolabials folds (WSRS grade 3-4);
• Reasonable potential benefit from correction;
• Subjects able to understand the full nature and the purpose of the investigation, including possible risks and side effects, able to cooperate with the Investigator and to comply with the requirements of the entire investigation (ability to attend all the planned investigation visits according to the time limits included) based on Investigator's judgement;
• Subjects must voluntarily give written informed consent, adhere to the protocol and report events and concomitant medication 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. For the entire duration of the investigation, female subjects of childbearing potential (i.e., not permanently sterilised - post hysterectomy or tubal ligation status - or not postmenopausal from at least one year) must adopt an appropriate method of contraception according to the definition of Note 3 of ICH M3 Guideline;
• Prior treatment of the face (e.g. 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 therapy during the study;
• Previous tissue augmentation with permanent implants (e.g., silicone) in the area to be treated;
• Presence of active inflammation, infection (acne, herpes, dermatitis, etc.) or unhealed wound of the face;
• Presence of varices in the area to be treated;
• History of hypertrophic scarring;
• Medical history or clinical examination positive for metabolic or endocrine serious diseases (e.g. uncontrolled diabetes or diabetes complications), anaphylaxis, severe allergies, immune disorders affecting the skin, other local or systemic concomitant diseases that may interfere with healing or with protocol evaluation parameters;
• Use of non-steroidal anti-inflammatory drugs (NSAIDs), analgesics, antiplatelets and anticoagulants in the week before treatment;
• Use of any other treatment or medication that, according to its pharmacological properties and in the opinion of the Investigator, can alter the perception of pain, started in the week before the screening visit;
• Use of narcotic agents, antineoplastics, immunosuppressants or of any other agent that may interfere with healing in the 4 weeks before the screening visit;
• Neurological or psychiatric diseases that may threaten the obtaining of informed consent or the adherence to investigation procedures;
• Ongoing neoplastic (including skin cancer) and/or immunodepressive diseases;
• Subjects with known allergy or hypersensitivity to at least one component of any of the investigational medical devices;
• Ongoing or scheduled during the study radiation, laser, ultrasound, chemical peels treatment in the target area;
• Known hypocoagulability state;

Sponsors & Collaborators

• Centro Medico Polispecialistico: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The products will be administered by the Investigator/Co-Investigator (Treating Investigator), while the evaluations will be done by a Co-Investigator not aware of the side type treatment (Blinded Evaluator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: pre-CE mark controlled, prospective, randomized, blinded evaluator, single centre, split-face clinical investigation

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 23, 2022
• Study Start: February 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: February 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share