Open, Non-Comparative Study To Evaluate The Performance And Safety Of The Medical Device JANESSE® (Hyaluronic Acid-Dermal Filler) In The Correction Of Facial Wrinkles
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Wrinkle
- Sponsor
- I.R.A. Istituto Ricerche Applicate S.p.A.
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- AE, SAE, ADE, SADE incidence
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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?
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men or women with age \> 35 and ≤ 65 years.
- •Subjects with nasolabial wrinkles, seeking tissue augmentation treatment and willing to receive HA Filler;
- •Subjects presenting a score of 2 (shallow wrinkles) or 3 (moderate, deep wrinkles) on the Wrinkles Severity Ranking Scale (WSRS);
- •Subjects who agree to discontinue all dermatological treatment and procedures during the study;
- •Subjects willing to provide signed informed consent to clinical investigation participation.
- •Able to communicate adequately with the Investigator and to comply with the requirements for the entire study.
Exclusion Criteria
- •Subjects who have bleeding disorder in the past or present.
- •Use of aspirin and antiplatelet agents a week prior to treatment
- •Prior or planned use of topical injection to the face (steroid, retinoid: applicable only to drugs, not applicable to cosmetics), within 4 weeks prior to screening or during this study (steroid ointment for therapeutic objectives is allowed for short -term use of ≤14 consecutive days.).
- •Use of immunosuppressive, chemotherapies, or systemic corticosteroids within 12 weeks from screening.
- •History of anaphylaxis or severe complicated allergy symptoms.
- •Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders or previous mental disorders that may significantly affect the study.
- •Hypersensitivity skin reaction to the investigational device based on intradermal test results at screening.
- •Evidence or history of autoimmune disease or compromised immune system.
- •Treatment with anticoagulants, thrombolytics, or platelet inhibitors within 1 week prior to study participation;
- •Prior permanent fillers or fat graft procedures around nasolabial folds.
Outcomes
Primary Outcomes
AE, SAE, ADE, SADE incidence
Time Frame: 12 weeks
AE, SAE, ADE, SADE incidence
WSRS score assessed by the Investigator
Time Frame: 12 weeks
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).
Secondary Outcomes
- WSRS score assessed by the patient(12 weeks)
- Global Aesthetic Improvement Scale evaluated by the subject(12 weeks)
- Treatment satisfaction questionnaire completed by the subject(12 weeks)
- Investigator Global Assessment of Performance (IGAP)(12 weeks)
- Investigator Global Assessment of Safety (IGAS)(12 weeks)
- Patient Global Assessment of Safety (PGAS)(12 weeks)