Status:
COMPLETED
MD Auralia (HA Filler) in Treatment of Nasolabial Wrinkles
Lead Sponsor:
I.R.A. Istituto Ricerche Applicate S.p.A.
Collaborating Sponsors:
Opera CRO, a TIGERMED Group Company
Conditions:
Nasolabial Fold, Hypoplastic
Eligibility:
All Genders
35-65 years
Phase:
NA
Brief 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 ...
Detailed Description
Minimally invasive procedures (injectable dermal fillers) are among the techniques preferred by an increasing number of specialists in Aesthetics due to their clinical performance regarding volume res...
Eligibility Criteria
Inclusion
- 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.
- Treatment with anticoagulants, thrombolytics, or platelet inhibitors within 1 week prior to study participation;
- Prior permanent fillers or fat graft procedures around nasolabial folds.
- Wrinkle correction procedures (e.g., botulinum toxin A injection, face lift, soft tissue augmentation, medium-depth peel, dermal photorejuvenation, etc.) within 6 months prior to study participation.
- History of hypersensitivity to local anesthetic of amide type or HA.
- History of keloid formation or hypertrophic scar on the face.
- Evidence of active infection on the face.
- Wound, scar, or skin disorder or infection around nasolabial folds 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.).
- As with all dermal filler procedures, the product should not be used in vascular rich areas.
- Subjects 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
Exclusion
Key Trial Info
Start Date :
September 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04101825
Start Date
September 16 2020
End Date
March 16 2021
Last Update
April 12 2021
Active Locations (1)
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1
SCM Dr. Rosu
Timișoara, Timiș County, Romania, 300425