Evaluating the Performance and Safety of the Medical Device Auralya® in the Treatment of Facial D… (NCT05239130) | Clinical Trial Compass
UnknownNot Applicable
Evaluating the Performance and Safety of the Medical Device Auralya® in the Treatment of Facial Dermal Tissue Defects
Romania48 participantsStarted 2022-03-21
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 (Auralya®) significantly decrease and / or improve their appearance, 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 by both pathologies or trauma, seeking tissue augmentation and skin imperfections 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.