MD Auralia (HA Filler) in Treatment of Nasolabial Wrinkles

NCT04101825 | Completed DMC

• 1 other identifier: OPIRA/0219/MD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Nasolabial Fold, Hypoplastic

Outcome Measures

Primary Outcomes (1)

• Evaluate safety and performance of Auralya

  To evaluate the overall safety of the medical device and performance of Auralya® dermal filler in terms of absolute change of Wrinkle Severity Rating Scale assessed by Investigator at 8 and 12 weeks after the initiation of treatment, compared to Baseline Visit (day 0).

  12 weeks

Secondary Outcomes (5)

• Change of Wrinkle Severity Rating Scale

  12 weeks

• General appearance after treatment

  12 weeks

• Subject satisfaction

  12 weeks

• Global evaluation of product performance

  12 weeks

• Product safety

  12 weeks

Study Arms (1)

Auralya

EXPERIMENTAL

Auralya® 25 (Cross-linked Hyaluronic Acid) Injection

Device: Auralya

Interventions

Auralya DEVICE

Hyaluronic Acid-Dermal Filler

Auralya

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• I.R.A. Istituto Ricerche Applicate S.p.A.: lead
• Opera CRO, a TIGERMED Group Company: collaborator

Study Sites (1)

SCM Dr. Rosu

Timișoara, Timiș County, 300425, Romania

Location

Related Publications (22)

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Study Officials

• Mihaela Fratila, MD

  SCM Dr. Rosu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: This trial is open label, multi-center, non-randomized single group.

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 24, 2019
• Study Start: September 16, 2020
• Primary Completion: March 16, 2021
• Study Completion: March 16, 2021
• Last Updated: April 12, 2021

Record last verified: 2021-04

Locations

RO (1)