Status:
COMPLETED
Evaluating the Performance and Safety of the Medical Device Janesse in the Treatment of Facial Dermal Tissue Defects
Lead Sponsor:
I.R.A. Istituto Ricerche Applicate S.p.A.
Collaborating Sponsors:
Opera CRO, a TIGERMED Group Company
Conditions:
Cicatrix
Lipodystrophy
Eligibility:
All Genders
18-65 years
Phase:
NA
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-l...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.).
- Need to exposure to the sun, UV rays and extreme conditions of heat for at least a week after the treatment.
- Need to have direct or indirect contact with quaternary ammonium salts during the study.
- 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.
- 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.
- Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days
Key Trial Info
Start Date :
March 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05239156
Start Date
March 14 2022
End Date
September 13 2022
Last Update
October 20 2022
Active Locations (1)
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1
SCM Dr. Rosu
Timișoara, Timiș County, Romania, 300425