The Research Question of the present study is the following: in a population of men and women presenting facial and neck dermal tissue defects (scars, hypertrophic scars, depressed plaques, and lipodystrophy defects) will linear hyaluronic acid (Jalucomplex®) significantly decrease and / or improve their appearance, results observed after 4 and 8 weeks?
Jalucomplex® 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. Linear hyaluronic acid is a polymer that represents one of the essential components of human skin, subcutaneous and connective tissue; its ability to form complexes with water molecules increases the level of tissue hydration, turgidity and plasticity. These characteristics allow Jalucomplex® 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. Non-crosslinked hyaluronic acid generates a lower reactivity that crosslinked forms, biocompatibility of hyaluronic acid-based materials decreasing with an increase in the number of modifications to this polysaccharide
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Device: Jalucomplex Jalucomplex is an injectable intradermal gel containing sodium salts derived from hyaluronic acid.
SCM Dr. Rosu
Timișoara, Timiș County, Romania
POSAS score assessed by Investigator and patient
To evaluate the overall performance of the medical dermal filler Jalucomplex® in treating facial and neck dermal tissue defects (scars, hypertrophic scars, depressed plaques, and lipodystrophy defects) in terms of change in Patient and Observer Scar Assessment Scale (POSAS) score, 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 Jalucomplex® in treating facial and neck dermal tissue defects (scars, hypertrophic scars, depressed plaques, and lipodystrophy defects) in terms of change in Patient and Observer Scar Assessment Scale (POSAS) score, assessed by Investigators and patients at 4 (28 days) after the initiation of treatment, compared to Visit 1 (day 0).
Time frame: 4 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 8 (day 56), compared to Visit 1 (day 0)
Time frame: 8 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: 8 weeks
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: 8 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
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Time frame: 8 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: 8 weeks
Global Aesthetic Improvement Scale evaluated by the patient (GAIS)
To evaluate general appearance after treatment assessed by the patient at 4 and 8 weeks (28 and 56 days) using the Global Aesthetic Improvement Scale (GAIS). The scale evaluates the appearance from 1 (very much improved) to 5 (worse than original condition) .
Time frame: 8 weeks
Treatment satisfaction assessment by the patient
To assess the patient satisfaction 4 and 8 weeks (28 and 56 days), providing their degree of satisfaction with the treatment on a four-point scale (very satisfied, satisfied, moderately satisfied, or not satisfied)
Time frame: 8 weeks
Investigator Global Assessment of Safety (IGAS)
To evaluate the global safety of product assessed by Investigator (IGAS), at week 8 (day 56), 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: 8 weeks
Patient Global Assessment of Safety (PGAS).
To evaluate the global safety of product assessed by the patient ( PGAS), at week 8 (day 56), 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: 8 weeks