MD Auralia (HA Filler) in Treatment of Nasolabial Wrinkles

April 9, 2021 updated by: I.R.A. Istituto Ricerche Applicate S.p.A.

Open, Non-comparative Study to Evaluate the Performance and Safety of the Medical Device AURALYA® (Hyaluronic Acid-dermal Filler) in the Treatment of Nasolabial Wrinkles to Obtain Facial Rejuvenation

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 restoration, and favourable safety profile.

During January - March 2018, it was performed a review of the scientific literature to find similar investigations to determine the minimal clinical significant difference between Baseline and a period of 30 days after the end the treatment.

In a similar dermal filler study, Takanobu Mashiko et al used a 5-grade WSRS and showed that, at 4 weeks after treatment, they achieved a 1.7 ± 0.5 (mean ± SD) improvement between those visits.

Considering the exploratory nature of this study and the fact that this investigation is first in-human, we choose to take a 0.5 WSRS decrease, at 90 days from the treatment start, as a minimal clinically significant difference. The standard deviation considered for the sample size calculation was set at 0.8 WSRS points.

By using a one-sided Wilcoxon Signed-rank test (matched pairs), a significance level of 0.05 and a power of 0.95 (probability of finding an effect when there is one), we calculated a total sample size of 31 subjects.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
    • Timis
      • Timişoara, Timis, Romania, 300425
        • SCM Dr. Rosu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Men or women with age > 35 and ≤ 65 years.
  2. Subjects with nasolabial wrinkles, seeking tissue augmentation treatment and willing to receive HA Filler;
  3. Subjects presenting a score of 2 (shallow wrinkles) or 3 (moderate, deep wrinkles) on the Wrinkles Severity Ranking Scale (WSRS);
  4. Subjects who agree to discontinue all dermatological treatment and procedures during the study;
  5. Subjects willing to provide signed informed consent to clinical investigation participation.
  6. Able to communicate adequately with the Investigator and to comply with the requirements for the entire study.

Exclusion criteria:

  1. Subjects who have bleeding disorder in the past or present.
  2. Use of aspirin and antiplatelet agents a week prior to treatment
  3. 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.).
  4. Use of immunosuppressive, chemotherapies, or systemic corticosteroids within 12 weeks from screening.
  5. History of anaphylaxis or severe complicated allergy symptoms.
  6. Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders or previous mental disorders that may significantly affect the study.
  7. Hypersensitivity skin reaction to the investigational device based on intradermal test results at screening.
  8. Evidence or history of autoimmune disease or compromised immune system.
  9. Treatment with anticoagulants, thrombolytics, or platelet inhibitors within 1 week prior to study participation;
  10. Prior permanent fillers or fat graft procedures around nasolabial folds.
  11. 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.
  12. History of hypersensitivity to local anesthetic of amide type or HA.
  13. History of keloid formation or hypertrophic scar on the face.
  14. Evidence of active infection on the face.
  15. Wound, scar, or skin disorder or infection around nasolabial folds that may affect the efficacy assessment.
  16. 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.).
  17. As with all dermal filler procedures, the product should not be used in vascular rich areas.
  18. 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.
  19. Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Auralya
Auralya® 25 (Cross-linked Hyaluronic Acid) Injection
Device: Auralya
Hyaluronic Acid-Dermal Filler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate safety and performance of Auralya
Time Frame: 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Wrinkle Severity Rating Scale
Time Frame: 12 weeks
Absolute change of WSRS score assessed by the subject at 2, 4, 8 and 12 weeks compared to Baseline Visit (day 0).
12 weeks
General appearance after treatment
Time Frame: 12 weeks
General appearance after treatment assessed by the subject at 2, 4, 8 and 12 weeks after the first treatment session compared to Baseline Visit (day 0) using the Global Aesthetic Improvement Scale (GAIS)
12 weeks
Subject satisfaction
Time Frame: 12 weeks
Subject satisfaction assessed at 2, 4, 8 and 12 weeks, through Treatment Satisfaction Questionnaire completed by the subject providing their degree of satisfaction with the treatment on a three-point scale (very satisfied, satisfied, or not satisfied)
12 weeks
Global evaluation of product performance
Time Frame: 12 weeks
Global evaluation of product performance by Investigator with photos taken at each visit. The photos will be compared in the final visit (week 12)
12 weeks
Product safety
Time Frame: 12 weeks
Global evaluation of product safety by Investigator and by the patient using Patient Global Assessment of Safety questionnaire
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I.R.A. Istituto Ricerche Applicate S.p.A.

Collaborators

Opera CRO, a TIGERMED Group Company

Investigators

  • Principal Investigator: Mihaela Fratila, MD, SCM Dr. Rosu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2020

Primary Completion (Actual)

March 16, 2021

Study Completion (Actual)

March 16, 2021

Study Registration Dates

First Submitted

September 20, 2019

First Submitted That Met QC Criteria

September 23, 2019

First Posted (Actual)

September 24, 2019

Study Record Updates

Last Update Posted (Actual)

April 12, 2021

Last Update Submitted That Met QC Criteria

April 9, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • OPIRA/0219/MD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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