The Research Question of the present study is the following: in a population of men and women presenting facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects) will cross-linked hyaluronic acid (Janesse®) significantly decrease and / or improve the appearance of these defects, results observed after 4, 8 and 12 weeks?
Janesse® action is to increase the volume of dermal-epidermal tissue, based on the natural ability of hydrophilic hyaluronic acid molecules to bind to an amount of water many times greater than their weight. This allows to fill the intradermal spaces and integrate the intercellular matrix, conferring turgidity to the tissues. The cross-linking of the hyaluronic acid contained in the product has the effect of more stable and durable filling over time. These characteristics allow Janesse® to be used as a temporary filler for subcutaneous areas to correct small defects in the dermal tissue due to lipodystrophies or the presence of fibrotic tissues as scars, caused by pathologies or trauma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Device: Janesse® is a sterile, injectable, non-pyrogenic, re-absorbable medical product made of reticulated hyaluronic acid of non-animal origin, produced via bacterial fermentation. The subjects will receive at baseline the first investigational medical device by the Investigator in accordance with the clinical investigation plan.
SCM Dr. Rosu
Timișoara, Timiș County, Romania
POSAS score assessed by Investigator and patient
To evaluate the overall performance of the medical dermal filler Janesse® in treating facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects) in terms of change in Patient and Observer Scar Assessment Scale (POSAS) score \[Draaijers, 2004; van de Kar, 2005\], assessed by Investigators and patients at 8 weeks (56 days) after the initiation of treatment, compared to Visit 1 (day 0).
Time frame: 8 weeks
POSAS score assessed by Investigator and patient
To evaluate the overall performance of the medical dermal filler Janesse® in treating facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects) in terms of change in Patient and Observer Scar Assessment Scale (POSAS) score \[Draaijers, 2004; van de Kar, 2005\], assessed by Investigators and patients at 4 weeks (28 days) after the initiation of treatment, compared to Visit 1 (day 0).
Time frame: 4 weeks
POSAS score assessed by Investigator and patient
To evaluate the overall performance of the medical dermal filler Janesse® in treating facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects) in terms of change in Patient and Observer Scar Assessment Scale (POSAS) score \[Draaijers, 2004; van de Kar, 2005\], assessed by Investigators and patients at 12 weeks (84 days) after the initiation of treatment, compared to Visit 1 (day 0).
Time frame: 12 weeks
Investigator Global Assessment of Performance (IGAP)
To evaluate the global performance of product assessed by Investigator through photos taken at each visit (IGAP), at week 12 (day 84), compared to Visit 1 (day 0).
Time frame: 12 weeks
Adverse Event incidence
To evaluate the safety of the device trough Adverse Event incidence assessed by Investigators at all visits and reported according to the current legislation.
Time frame: 12 weeks
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Serious Adverse Event incidence
To evaluate the safety of the device trough Serious Adverse Event incidence assessed by Investigators at all visits and reported according to the current legislation.
Time frame: 12 weeks
Adverse Device Event incidence
To evaluate the safety of the device trough Adverse device event incidence assessed by Investigators at all visits and reported according to the current legislation.
Time frame: 12 weeks
Serious Adverse Device Event incidence
To evaluate the safety of the device trough Serious Adverse Device Event incidence assessed by Investigators at all visits and reported according to the current legislation.
Time frame: 12 weeks
Global Aesthetic Improvement Scale evaluated by the patient (GAIS)
To evaluate general appearance after treatment assessed by the patient at 4, 8 and 12 weeks (28, 56 and 84 days) using the Global Aesthetic Improvement Scale (GAIS) \[Kim, 2016\], \[Kopera, 2015 - 2018\], \[McCall-Perez, 2011\], \[Savoia, 2015\]. The scale evaluates the appearance from 1 (very much improved) to 5 (worse than original condition) .
Time frame: 12 weeks
Treatment satisfaction assessment by the patient
To assess the patient satisfaction at 4, 8 and 12 weeks (28, 56 and 84 days), providing their degree of satisfaction with the treatment on a four-point scale (very satisfied, satisfied, moderately satisfied, or not satisfied)
Time frame: 12 weeks
Investigator Global Assessment of Safety (IGAS)
To evaluate the global safety of product assessed by Investigator (IGAS), at week 12 (day 84), compared to Visit 1 (day 0), providing the safety on a four point scale from 4 meaning poor safety to 1 meaning very good safety.
Time frame: 12 weeks
Patient Global Assessment of Safety (PGAS)
To evaluate the global safety of product assessed by the patient (PGAS), at week 12 (day 84), compared to Visit 1 (day 0), providing the safety on a four point scale from 4 meaning poor safety to 1 meaning very good safety.
Time frame: 12 weeks