Open, Non-Comparative Study To Evaluate The Performance Of The Medical Device JANESSE®

NCT ID: NCT04103125

Last Updated: 2021-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-14
• Study Completion Date: 2020-12-21

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?

Conditions

Wrinkle

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Janesse

Janesse® 20 (Cross-linked Hyaluronic Acid) Injection: follow the instruction for use

Group Type: OTHER

Janesse® is a sterile, injectable, non-pyrogenic, re-absorbable medical product made of reticulated hyaluronic acid of non-animal origin, produced via bacterial fermentation.

Intervention Type: DEVICE

The subjects will receive at baseline the first IMD by the Investigator in accordance with the CIP

Interventions

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 IMD by the Investigator in accordance with the CIP

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Men or women with age > 35 and ≤ 65 years.

2. Subjects with nasolabial wrinkles, seeking tissue augmentation treatment and willing to receive HA Filler;

3. Subjects presenting a score of 2 (shallow wrinkles) or 3 (moderate, deep wrinkles) on the Wrinkles Severity Ranking Scale (WSRS);

4. Subjects who agree to discontinue all dermatological treatment and procedures during the study;

5. Subjects willing to provide signed informed consent to clinical investigation participation.

6. Able to communicate adequately with the Investigator and to comply with the requirements for the entire study.

Exclusion Criteria

1. Subjects who have bleeding disorder in the past or present.

2. Use of aspirin and antiplatelet agents a week prior to treatment

3. 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.).

4. Use of immunosuppressive, chemotherapies, or systemic corticosteroids within 12 weeks from screening.

5. History of anaphylaxis or severe complicated allergy symptoms.

6. Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders or previous mental disorders that may significantly affect the study.

7. Hypersensitivity skin reaction to the investigational device based on intradermal test results at screening.

8. Evidence or history of autoimmune disease or compromised immune system.

9. Treatment with anticoagulants, thrombolytics, or platelet inhibitors within 1 week prior to study participation;

10. Prior permanent fillers or fat graft procedures around nasolabial folds.

11. 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.

12. History of hypersensitivity to local anesthetic of amide type or HA.

13. History of keloid formation or hypertrophic scar on the face.

14. Evidence of active infection on the face.

15. Wound, scar, or skin disorder or infection around nasolabial folds that may affect the efficacy assessment.

16. 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.).

17. As with all dermal filler procedures, the product should not be used in vascular rich areas.

18. 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.

19. Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Opera CRO, a TIGERMED Group Company

OTHER

Sponsor Role: collaborator

I.R.A. Istituto Ricerche Applicate S.p.A.

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mihaela Fratila

Role: PRINCIPAL_INVESTIGATOR

SCM Dr. Rosu

Locations

SCM Dr. Rosu

Timișoara, Timiș County, Romania

Countries

Romania

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Other Identifiers

OPIRA/0119/MD

Identifier Type: -

Identifier Source: org_study_id