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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05252325
Other study ID # HA28L/MD01/20
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 2022
Est. completion date March 2023

Study information

Verified date February 2022
Source Centro Medico Polispecialistico
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 side, in randomized fashion.


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


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Study Design


Related Conditions & MeSH terms


Intervention

Device:
hyaluronic acid plus lidocaine
local injection for correction of nasolabials fold
hyaluronic acid without lidocaine
local injection for correction of nasolabial folds

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Centro Medico Polispecialistico

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
done by the subject at weeks 2, 12 and 24 after treatments, separately for each side of the face
Secondary 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
done by the blind evaluator before intervention and 12-24 weeks after injections, separately for each side of the face
Secondary Clinical efficacy Global satisfaction assessment (GSA) scale:
unsatisfying satisfying very satisfying
done by the blind evaluator and by the the subject at the week 24 of the study, separately for each side of the face
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