The hypothesis of this clinical investigation is that in a population of men and women affected by periocular wrinkles, lip contour wrinkles or deep facial wrinkles, will cross-linked hyaluronic acid (Janesse) significantly decrease the appearance of facial wrinkles, results observed after 4, 8 and 12 weeks.
Janesse®'s 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 allow 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. The Research Question of the present study is the following: in a population of men and women affected by periocular wrinkles, lip contour wrinkles or deep facial wrinkles, will cross-linked hyaluronic acid (Janesse®) significantly decrease the appearance of nasolabial wrinkles, results observed after 12 weeks?
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
The subjects will receive at baseline the first IMD by the Investigator in accordance with the CIP
SCM Dr. Rosu
Timișoara, Timiș County, Romania
WSRS score assessed by the Investigator
To evaluate the overall safety of the medical device and performance of Janesse® dermal filler in terms of absolute change of WSRS score (Wrinkle Severity Rating Scale) assessed by Investigator at 4, 8 and 12 weeks after the initiation of treatment, compared to Baseline Visit (day 0).
Time frame: 12 weeks
AE, SAE, ADE, SADE incidence
AE, SAE, ADE, SADE incidence
Time frame: 12 weeks
WSRS score assessed by the patient
To evaluate the performance of the medical device in terms of change of WSRS score assessed by the subject at 4, 8 and 12 weeks compared to Baseline Visit 1 (day 0).
Time frame: 12 weeks
Global Aesthetic Improvement Scale evaluated by the subject
Subjects will evaluate their skin appearance change compared to before the treatment, as follows: * Very Much Improved (1) = Optimal cosmetic result; * Much Improved (2) = Market improvement in appearance but not completely optimal. A touch-up would slightly improve the result; * Improved (3) = Obvious improvement in appearance from the initial condition, but a touch-up or re-treatment is indicated; * No Change (4) = The appearance is essentially the same as the original condition; * Worse (5) = The appearance is worse than the original condition.
Time frame: 12 weeks
Treatment satisfaction questionnaire completed by the subject
To assess the subject satisfaction at 4, 8 and 12 weeks, providing their degree of satisfaction with the treatment on a four-point scale (very satisfied, satisfied, moderate or not satisfied).
Time frame: 12 weeks
Investigator Global Assessment of Performance (IGAP)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Investigator Global Assessment of Performance (IGAP) Investigator will make photographs at every visit (1, 2, 3, 4 and 5) of the area treated in order to evaluate the performance of the treatment at visit 5 using a 4-point scale: 1= very good performance, 2 = good performance, 3 = moderate performance and 4 = poor performance;taken at each visit.
Time frame: 12 weeks
Investigator Global Assessment of Safety (IGAS)
Investigator Global Assessment of Safety (IGAS) will be reported using the 4-point scale: 1= very good safety, 2 = good safety, 3 = moderate safety and 4 = poor safety. IGAS will be evaluated by the Investigator at Final visit (12 weeks), only;
Time frame: 12 weeks
Patient Global Assessment of Safety (PGAS)
Patient Global Assessment of Safety (PGAS) will be reported by the subject at the last visit using the 4-point scale: 1= very good safety, 2 = good safety, 3 = moderate safety and 4 = poor safety. PGAS will be evaluated by the patient at Final visit (12 weeks), only.
Time frame: 12 weeks