Nasolabial Folds
Conditions
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.
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
Interventions
DEVICEhyaluronic acid plus lidocaine
local injection for correction of nasolabials fold
DEVICEhyaluronic acid without lidocaine
local injection for correction of nasolabial folds
Sponsors
Centro Medico Polispecialistico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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)
Intervention model description
pre-CE mark controlled, prospective, randomized, blinded evaluator, single centre, split-face clinical investigation
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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; * 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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical efficacy | done by the subject at weeks 2, 12 and 24 after treatments, separately for each side of the face | 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. |
Outcome results
None listed