Status:
COMPLETED
Open, Non-Comparative Study To Evaluate The Performance Of The Medical Device JANESSE®
Lead Sponsor:
I.R.A. Istituto Ricerche Applicate S.p.A.
Collaborating Sponsors:
Opera CRO, a TIGERMED Group Company
Conditions:
Wrinkle
Eligibility:
All Genders
35-65 years
Phase:
NA
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
- Wrinkle correction procedures (e.g., botulinum toxin A injection, face lift, soft tissue augmentation, medium-depth peel, dermal photorejuvenation, etc.) within 6 months prior to study participation.
- History of hypersensitivity to local anesthetic of amide type or HA.
- History of keloid formation or hypertrophic scar on the face.
- Evidence of active infection on the face.
- Wound, scar, or skin disorder or infection around nasolabial folds that may affect the efficacy assessment.
- Pregnant woman, lactating woman, and man or woman of childbearing potential who is planning a pregnancy or is unwilling to use appropriate methods of contraception\* during the study, \*Methods of contraception: hormonal contraceptive, intrauterine device or intrauterine system, double barrier method (condom with spermicide/diaphragm or cervical cap with spermicide), surgical sterilization (vasectomy, tubal ligation, etc.).
- As with all dermal filler procedures, the product should not be used in vascular rich areas.
- Subjects with illness, or other medical condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the study.
- Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.
Key Trial Info
Start Date :
July 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2020
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT04103125
Start Date
July 14 2020
End Date
December 21 2020
Last Update
February 10 2021
Active Locations (1)
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1
SCM Dr. Rosu
Timișoara, Timiș County, Romania, 300425