Evaluating the Performance and Safety of the Medical Device Janesse in the Treatment of Facial Dermal Tissue Defects

I.R.A. Istituto Ricerche Applicate

Status: Completed

Conditions: Cicatrix; Plaque; Lipodystrophy

Treatments: Device: Janesse

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT05239156

OPIRA/0221/MD

Details and patient eligibility

About

The Research Question of the present study is the following: in a population of men and women presenting facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects) will cross-linked hyaluronic acid (Janesse®) significantly decrease and / or improve the appearance of these defects, results observed after 4, 8 and 12 weeks?

Full description

Janesse® 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. The cross-linking of the hyaluronic acid contained in the product has the effect of more stable and durable filling over time. These characteristics allow Janesse® 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Men or women with age ≥ 18 and ≤ 65 years.
2. Patients with facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects) caused both by pathologies or trauma, seeking tissue augmentation treatment and willing to receive Hyaluronic Acid Filler.
3. Patients who agree to discontinue any other dermatological treatment and procedures during the study.
4. Patients willing to provide signed informed consent to clinical investigation participation.
5. Patients able to communicate adequately with the Investigator and to comply with the requirements for the entire study.

Exclusion criteria

1. Past or current bleeding disorders.
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. Known hypersensitivity skin reaction to hyaluronic acid or hypersensitivity skin reaction to the investigational device based on intradermal test results at visit 1.
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 facial dermal tissue defects.
11. Facial dermal tissue defects correction procedures (e.g., botulinum toxin A injection, face lift, soft tissue augmentation, medium-depth peel, dermal photo-rejuvenation, etc.) around infraorbital region within 6 months prior to study participation.
12. History of hypersensitivity to local anaesthetic 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, skin disorder or infection around facial dermal tissue defects 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. Need to exposure to the sun, UV rays and extreme conditions of heat for at least a week after the treatment.
18. Need to have direct or indirect contact with quaternary ammonium salts during the study.
19. As with all dermal filler procedures, the product should not be used in vascular rich areas. Using the product at sites such as Glabella and nose may inadvertently be injected into the blood vessels, resulting in symptom of vessel occlusion such as colour vision deficiency and blindness.
20. Patients 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.
21. Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

48 participants in 3 patient groups

Janesse 15

Experimental group

Description:

Sixteen patients will be administered Janesse® 15 (Cross-linked Hyaluronic Acid) for the treatment of minor facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects).

Treatment:

Device: Janesse

Janesse 20

Experimental group

Description:

Sixteen patients will be administered Janesse® 20 (Cross-linked Hyaluronic Acid) for the treatment of medium-sized facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects).

Treatment:

Device: Janesse

Janesse 25

Experimental group

Description:

Sixteen patients will be administered Janesse® 25 (Cross-linked Hyaluronic Acid) for the treatment of major facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects).

Treatment:

Device: Janesse