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

NCT05239156 | Completed

• 1 other identifier: OPIRA/0221/MD
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Cicatrix; Lipodystrophy; Plaque

Outcome Measures

Primary Outcomes (8)

• POSAS score assessed by Investigator and patient

  To evaluate the overall performance of the medical dermal filler Janesse® in treating facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects) in terms of change in Patient and Observer Scar Assessment Scale (POSAS) score \[Draaijers, 2004; van de Kar, 2005\], assessed by Investigators and patients at 8 weeks (56 days) after the initiation of treatment, compared to Visit 1 (day 0).

  8 weeks

• POSAS score assessed by Investigator and patient

  To evaluate the overall performance of the medical dermal filler Janesse® in treating facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects) in terms of change in Patient and Observer Scar Assessment Scale (POSAS) score \[Draaijers, 2004; van de Kar, 2005\], assessed by Investigators and patients at 4 weeks (28 days) after the initiation of treatment, compared to Visit 1 (day 0).

  4 weeks

• POSAS score assessed by Investigator and patient

  To evaluate the overall performance of the medical dermal filler Janesse® in treating facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects) in terms of change in Patient and Observer Scar Assessment Scale (POSAS) score \[Draaijers, 2004; van de Kar, 2005\], assessed by Investigators and patients at 12 weeks (84 days) after the initiation of treatment, compared to Visit 1 (day 0).

  12 weeks

• Investigator Global Assessment of Performance (IGAP)

  To evaluate the global performance of product assessed by Investigator through photos taken at each visit (IGAP), at week 12 (day 84), compared to Visit 1 (day 0).

  12 weeks

• Adverse Event incidence

  To evaluate the safety of the device trough Adverse Event incidence assessed by Investigators at all visits and reported according to the current legislation.

  12 weeks

• Serious Adverse Event incidence

  To evaluate the safety of the device trough Serious Adverse Event incidence assessed by Investigators at all visits and reported according to the current legislation.

  12 weeks

• Adverse Device Event incidence

  To evaluate the safety of the device trough Adverse device event incidence assessed by Investigators at all visits and reported according to the current legislation.

  12 weeks

• Serious Adverse Device Event incidence

  To evaluate the safety of the device trough Serious Adverse Device Event incidence assessed by Investigators at all visits and reported according to the current legislation.

  12 weeks

Secondary Outcomes (4)

• Global Aesthetic Improvement Scale evaluated by the patient (GAIS)

  12 weeks

• Treatment satisfaction assessment by the patient

  12 weeks

• Investigator Global Assessment of Safety (IGAS)

  12 weeks

• Patient Global Assessment of Safety (PGAS)

  12 weeks

Study Arms (3)

Janesse 15

EXPERIMENTAL

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).

Device: Janesse

Janesse 20

EXPERIMENTAL

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).

Device: Janesse

Janesse 25

EXPERIMENTAL

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).

Device: Janesse

Interventions

Janesse DEVICE

Device: 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 investigational medical device by the Investigator in accordance with the clinical investigation plan.

Janesse 15; Janesse 20; Janesse 25

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women with age ≥ 18 and ≤ 65 years.
• 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.
• Patients who agree to discontinue any other dermatological treatment and procedures during the study.
• Patients willing to provide signed informed consent to clinical investigation participation.
• Patients able to communicate adequately with the Investigator and to comply with the requirements for the entire study.

You may not qualify if:

• Past or current bleeding disorders.
• 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.
• Known hypersensitivity skin reaction to hyaluronic acid or hypersensitivity skin reaction to the investigational device based on intradermal test results at visit 1.
• 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 facial dermal tissue defects.
• 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.
• History of hypersensitivity to local anaesthetic of amide type or HA.
• History of keloid formation or hypertrophic scar on the face.
• Evidence of active infection on the face.
• Wound, skin disorder or infection around facial dermal tissue defects that may affect the efficacy assessment.

Sponsors & Collaborators

• I.R.A. Istituto Ricerche Applicate S.p.A.: lead
• Opera CRO, a TIGERMED Group Company: collaborator

Study Sites (1)

SCM Dr. Rosu

Timișoara, Timiș County, 300425, Romania

Location

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MeSH Terms

Conditions

Cicatrix; Lipodystrophy; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathological Conditions, Anatomical

Study Officials

• Mihaela Fratila

  SCM Dr. Rosu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 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). 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). 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: This is a multi-center, open-label, non-randomized clinical investigation

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: February 14, 2022
• Study Start: March 14, 2022
• Primary Completion: September 13, 2022
• Study Completion: September 13, 2022
• Last Updated: October 20, 2022

Record last verified: 2022-03

Locations

RO (1)