Evaluating the Performance and Safety of the Medical Device Janesse in the Treatment of Facial De… (NCT05239156) | Clinical Trial Compass
CompletedNot Applicable
Evaluating the Performance and Safety of the Medical Device Janesse in the Treatment of Facial Dermal Tissue Defects
Romania48 participantsStarted 2022-03-14
Plain-language 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?
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
POSAS score assessed by Investigator and patient
Timeframe: 8 weeks
2
POSAS score assessed by Investigator and patient
Timeframe: 4 weeks
3
POSAS score assessed by Investigator and patient
Timeframe: 12 weeks
4
Investigator Global Assessment of Performance (IGAP)
✕. 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.