MD Auralia (HA Filler) in Treatment of Nasolabial Wrinkles (NCT04101825) | Clinical Trial Compass
CompletedNot Applicable
MD Auralia (HA Filler) in Treatment of Nasolabial Wrinkles
Romania60 participantsStarted 2020-09-16
Plain-language summary
Auralya® is a sterile, injectable, non-pyrogenic, re-absorbable medical product made of reticulated hyaluronic acid of non-animal origin, produced via bacterial fermentation.
To evaluate the overall safety of the medical device and performance of Auralya® dermal filler in terms of absolute change of WSRS score (Wrinkle Severity Rating Scale) assessed by Investigator at 8 and 12 weeks after the initiation of treatment, compared to Baseline Visit (day 0).
Who can participate
Age range35 Years – 65 Years
SexALL
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Inclusion criteria
✓. Men or women with age \> 35 and ≤ 65 years.
✓. Subjects with nasolabial wrinkles, seeking tissue augmentation treatment and willing to receive HA Filler;
✓. Subjects presenting a score of 2 (shallow wrinkles) or 3 (moderate, deep wrinkles) on the Wrinkles Severity Ranking Scale (WSRS);
✓. Subjects who agree to discontinue all dermatological treatment and procedures during the study;
✓. Subjects willing to provide signed informed consent to clinical investigation participation.
✓. Able to communicate adequately with the Investigator and to comply with the requirements for the entire study.
Exclusion criteria
✕. Subjects who have bleeding disorder in the past or present.
✕. 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.
✕. Hypersensitivity skin reaction to the investigational device based on intradermal test results at screening.
✕. Evidence or history of autoimmune disease or compromised immune system.