Nasolabial FoldsNCT05252325
Clinical Study on Hyaluronic Acid With Lidocaine for the Treatment of Moderate to Severe Nasolabial Folds
A study testing hyaluronic acid plus lidocaine and hyaluronic acid without lidocaine in people with Nasolabial Folds, run by Centro Medico Polispecialistico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasolabial Folds
- What is being tested?
- hyaluronic acid plus lidocaine and hyaluronic acid without lidocaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2022to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- History of drugs and/or alcohol abuse;
- Subjects unable to measure pain properly by means of a visual analogue scale (VAS);
- Subjects considered to be unsuitable to participate, in the investigators opinion, for any other reason;
- Planned relocation during the study, which would make follow-up visits impossible;
- Concomitant participation in other clinical investigations or participation in the evaluation of any investigational drugs/devices during 3 months before this investigation or previous participation in the same investigation or planned to receive other investigational products during the study .
About this study
Official title: Prospective, Controlled, Randomized, Blinded Evaluator, Split-face Clinical Study to Evaluate the Efficacy and Safety of Hyaluronic Acid Hydrogel With Lidocaine Lidocaine for the Treatment of Moderate to Severe Nasolabial Folds
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.
Read the detailed description
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) on the one side of the face, the other (HA) on the other side, in randomized fashion.
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).
The investigational plan include a Visit 1, during which subjects will be screened for entry (inclusion/exclusion) criteria; eligible subjects will be treated with the medical devices and followed for the next hour for pain and safety evaluation.
Visit 2, 3 and Visit 4 are schedule after 2 (± 2 days), 12 (± 10 days) e 24 (± 10 days) weeks for the assessment of safety and clinical efficacy.
Subjects prematurely discontinued from the investigation after the treatment will perform an 'Early termination visit', in which procedures scheduled for Visit 4 (24 weeks, final visit) will be performed (whenever feasible). In case of premature discontinuation of the investigation, the Investigator will duly record the reason for premature withdrawal in the appropriate section of the case report form (CRF).
Visit 4 (or the 'Early termination Visit') will represent the conclusion of subject's participation in the investigation.
Adverse events will be recorded during the entire investigational period by investigator's assessment and subjects' spontaneous reporting. Vital signs (blood pressure and heart rate) will be measured at each visit in the investigational site
- Conditions
- Nasolabial Folds
- Being tested
- hyaluronic acid plus lidocaine, hyaluronic acid without lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyaluronic acid plus lidocaineDevice
local injection for correction of nasolabials fold
hyaluronic acid without lidocaineDevice
local injection for correction of nasolabial folds
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: hyaluronic acid plus lidocaine; Device: hyaluronic acid without lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 1 min and 15-30-45-60 minutes after each injection
Secondary outcomes (3)
Clinical efficacy
Global Aesthetic Improvement Scale (GAIS):
very much improved: excellent corrective result; much improved: marked improvement of the appearance, but not optimal; improved: improvement of the appearance, better compared with the initial condition, but a touch-up is advised; no change: the appearance substantially remains unchanged in respect of the original condition; worse: the appearance worsened compared with the initial condition.
Measured: done by the subject at weeks 2, 12 and 24 after treatments, separately for each side of the face
Clinical efficacy
Wrinkle Severity Rating Scale (WSRS):
- absent- no visible nasolabial fold; continuous skin line
- mild - shallow but visible nasolabial fold with a slight indentation; minor facial feature; implant is expected to produce a slight improvement in appearance
- moderate- moderately deep nasolabial fold; clear facial feature visible at normal appearance but not when stretched; excellent correction is expected from injectable implant
- severe- very long and deep nasolabial fold; prominent facial feature; <2 mm visible fold when stretched; significant improvement is expected from injectable implant
- extreme- extremely deep and long nasolabial fold, detrimental to facial appearance; 2-4 mm visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone
Measured: done by the blind evaluator before intervention and 12-24 weeks after injections, separately for each side of the face
Clinical efficacy
Global satisfaction assessment (GSA) scale:
unsatisfying satisfying very satisfying
Measured: done by the blind evaluator and by the the subject at the week 24 of the study, separately for each side of the face
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study startFeb 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial FoldsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pre-CE mark controlled, prospective, randomized, blinded evaluator, single centre, split-face clinical investigation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Medico Polispecialistico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252325
- Sponsor's protocol ID
- HA28L/MD01/20
- Status last verified
- Feb 2022
- First submitted
- 20 Jan 2022
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Controlled, Randomized, Blinded Evaluator, Split-face Clinical Study to Evaluate the Efficacy and Safety of Hyaluronic Acid Hydrogel With Lidocaine Lidocaine for the Treatment of Moderate to Severe Nasolabial Folds
- ClinicalTrials.gov ID
- NCT05252325
- Acronym / sponsor ID
- HA28L/MD01/20
- Conditions
- Nasolabial Folds
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centro Medico PolispecialisticoUniversity, hospital or other
- Study start
- Feb 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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) on the one side of the face, the other (HA) on the other side, in randomized fashion.
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).
The investigational plan include a Visit 1, during which subjects will be screened for entry (inclusion/exclusion) criteria; eligible subjects will be treated with the medical devices and followed for the next hour for pain and safety evaluation.
Visit 2, 3 and Visit 4 are schedule after 2 (± 2 days), 12 (± 10 days) e 24 (± 10 days) weeks for the assessment of safety and clinical efficacy.
Subjects prematurely discontinued from the investigation after the treatment will perform an 'Early termination visit', in which procedures scheduled for Visit 4 (24 weeks, final visit) will be performed (whenever feasible). In case of premature discontinuation of the investigation, the Investigator will duly record the reason for premature withdrawal in the appropriate section of the case report form (CRF).
Visit 4 (or the 'Early termination Visit') will represent the conclusion of subject's participation in the investigation.
Adverse events will be recorded during the entire investigational period by investigator's assessment and subjects' spontaneous reporting. Vital signs (blood pressure and heart rate) will be measured at each visit in the investigational site
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- pre-CE mark controlled, prospective, randomized, blinded evaluator, single centre, split-face clinical investigation
| Arm | Type | Receives |
|---|---|---|
| HAL on the right side of the face; HA on the left side of the face | Other | Device: hyaluronic acid plus lidocaine, Device: hyaluronic acid without lidocainethe subjects will receive HAL ( hyaluronic acid +lidocaine)in the right side of the face, HA (hyaluronic acid without lidocaine) in the left side |
| HAL on the left side of the face; HA on the right side | Other | Device: hyaluronic acid plus lidocaine, Device: hyaluronic acid without lidocainethe subjects will receive HA in the right side of the face, HAL in the left side |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyaluronic acid plus lidocainelocal injection for correction of nasolabials fold | Device | 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 lidocainelocal injection for correction of nasolabial folds | Device | 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 |
Primary outcome
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)
Time frame: within 1 min and 15-30-45-60 minutes after each injection
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.
3 secondary outcomes
Clinical efficacy
Time frame: done by the subject at weeks 2, 12 and 24 after treatments, separately for each side of the face
Clinical efficacy
Time frame: done by the blind evaluator before intervention and 12-24 weeks after injections, separately for each side of the face
Clinical efficacy
Time frame: done by the blind evaluator and by the the subject at the week 24 of the study, separately for each side of the face
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing hyaluronic acid plus lidocaine and hyaluronic acid without lidocaine in people with Nasolabial Folds, run by Centro Medico Polispecialistico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: within 1 min and 15-30-45-60 minutes after each injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022.