MD Auralia (HA Filler) in Treatment of Nasolabial Wrinkles

Nasolabial Fold, Hypoplastic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04101825
• Other study ID #: OPIRA/0219/MD
• Status: Completed
• Phase: N/A
• Start date: September 16, 2020
• Est. completion date: March 16, 2021

Study information

• Verified date: April 2021
• Source: I.R.A. Istituto Ricerche Applicate S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 16, 2021
• Est. primary completion date: March 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nasolabial Fold, Hypoplastic

Intervention

Device:
• Auralya
Hyaluronic Acid-Dermal Filler

Locations

Country	Name	City	State
Romania	SCM Dr. Rosu	Timisoara	Timis

Sponsors (2)

Lead Sponsor	Collaborator
I.R.A. Istituto Ricerche Applicate S.p.A.	Opera CRO, a TIGERMED Group Company

Country where clinical trial is conducted

Romania, 

References & Publications (22)

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Callan P, Goodman GJ, Carlisle I, Liew S, Muzikants P, Scamp T, Halstead MB, Rogers JD. Efficacy and safety of a hyaluronic acid filler in subjects treated for correction of midface volume deficiency: a 24 month study. Clin Cosmet Investig Dermatol. 2013 Mar 20;6:81-9. doi: 10.2147/CCID.S40581. Print 2013. — View Citation

Chen WY, Abatangelo G. Functions of hyaluronan in wound repair. Wound Repair Regen. 1999 Mar-Apr;7(2):79-89. Review. — View Citation

De Boulle K, Heydenrych I. Patient factors influencing dermal filler complications: prevention, assessment, and treatment. Clin Cosmet Investig Dermatol. 2015 Apr 15;8:205-14. doi: 10.2147/CCID.S80446. eCollection 2015. Review. — View Citation

Dong J, Gantz M, Goldenberg G. Efficacy and safety of new dermal fillers. Cutis. 2016 Nov;98(5):309-313. Review. — View Citation

Few J, Cox SE, Paradkar-Mitragotri D, Murphy DK. A Multicenter, Single-Blind Randomized, Controlled Study of a Volumizing Hyaluronic Acid Filler for Midface Volume Deficit: Patient-Reported Outcomes at 2 Years. Aesthet Surg J. 2015 Jul;35(5):589-99. doi: 10.1093/asj/sjv050. Epub 2015 May 11. — View Citation

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Funt D, Pavicic T. Dermal fillers in aesthetics: an overview of adverse events and treatment approaches. Plast Surg Nurs. 2015 Jan-Mar;35(1):13-32. doi: 10.1097/PSN.0000000000000087. — View Citation

Ghooi RB, Bhosale N, Wadhwani R, Divate P, Divate U. Assessment and classification of protocol deviations. Perspect Clin Res. 2016 Jul-Sep;7(3):132-6. doi: 10.4103/2229-3485.184817. — View Citation

Jiang LI, Stephens TJ, Goodman R. SWIRL, a clinically validated, objective, and quantitative method for facial wrinkle assessment. Skin Res Technol. 2013 Nov;19(4):492-8. doi: 10.1111/srt.12073. Epub 2013 Jun 10. — View Citation

Kim BW, Moon IJ, Yun WJ, Chung BY, Kim SD, Lee GY, Chang SE. A Randomized, Evaluator-Blinded, Split-Face Comparison Study of the Efficacy and Safety of a Novel Mannitol Containing Monophasic Hyaluronic Acid Dermal Filler for the Treatment of Moderate to Severe Nasolabial Folds. Ann Dermatol. 2016 Jun;28(3):297-303. doi: 10.5021/ad.2016.28.3.297. Epub 2016 May 25. — View Citation

Kopera D, Palatin M, Bartsch R, Bartsch K, O'Rourke M, Höller S, Baumgartner RR, Prinz M. An open-label uncontrolled, multicenter study for the evaluation of the efficacy and safety of the dermal filler Princess VOLUME in the treatment of nasolabial folds. Biomed Res Int. 2015;2015:195328. doi: 10.1155/2015/195328. Epub 2015 Mar 3. — View Citation

Kühne U, Esmann J, von Heimburg D, Imhof M, Weissenberger P, Sattler G. Safety and performance of cohesive polydensified matrix hyaluronic acid fillers with lidocaine in the clinical setting - an open-label, multicenter study. Clin Cosmet Investig Dermatol. 2016 Oct 20;9:373-381. eCollection 2016. — View Citation

Lemperle G, Holmes RE, Cohen SR, Lemperle SM. A classification of facial wrinkles. Plast Reconstr Surg. 2001 Nov;108(6):1735-50; discussion 1751-2. — View Citation

Lorenc ZP, Bank D, Kane M, Lin X, Smith S. Validation of a four-point photographic scale for the assessment of midface volume loss and/or contour deficiency. Plast Reconstr Surg. 2012 Dec;130(6):1330-1336. doi: 10.1097/PRS.0b013e31826d9fa6. — View Citation

McCall-Perez F, Stephens TJ, Herndon JH Jr. Efficacy and tolerability of a facial serum for fine lines, wrinkles, and photodamaged skin. J Clin Aesthet Dermatol. 2011 Jul;4(7):51-4. — View Citation

Rivkin AZ. Volume correction in the aging hand: role of dermal fillers. Clin Cosmet Investig Dermatol. 2016 Aug 30;9:225-32. doi: 10.2147/CCID.S92853. eCollection 2016. — View Citation

Rzany B, Cartier H, Kestemont P, Trevidic P, Sattler G, Kerrouche N, Dhuin JC, Ma YM. Full-face rejuvenation using a range of hyaluronic acid fillers: efficacy, safety, and patient satisfaction over 6 months. Dermatol Surg. 2012 Jul;38(7 Pt 2):1153-61. doi: 10.1111/j.1524-4725.2012.02470.x. — View Citation

Stephens TJ, Sigler ML, Herndon JH Jr, Dispensa L, Le Moigne A. A placebo-controlled, double-blind clinical trial to evaluate the efficacy of Imedeen(®) Time Perfection(®) for improving the appearance of photodamaged skin. Clin Cosmet Investig Dermatol. 2016 Mar 15;9:63-70. doi: 10.2147/CCID.S98787. eCollection 2016. — View Citation

Sudha PN, Rose MH. Beneficial effects of hyaluronic acid. Adv Food Nutr Res. 2014;72:137-176. doi: 10.1016/B978-0-12-800269-8.00009-9. Review. — View Citation

Van Dyke S, Hays GP, Caglia AE, Caglia M. Severe Acute Local Reactions to a Hyaluronic Acid-derived Dermal Filler. J Clin Aesthet Dermatol. 2010 May;3(5):32-5. — View Citation

Yeom J, Bhang SH, Kim BS, Seo MS, Hwang EJ, Cho IH, Park JK, Hahn SK. Effect of cross-linking reagents for hyaluronic acid hydrogel dermal fillers on tissue augmentation and regeneration. Bioconjug Chem. 2010 Feb 17;21(2):240-7. doi: 10.1021/bc9002647. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of Wrinkle Severity Rating Scale	Absolute change of WSRS score assessed by the subject at 2, 4, 8 and 12 weeks compared to Baseline Visit (day 0).	12 weeks
Secondary	General appearance after treatment	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
Secondary	Subject satisfaction	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
Secondary	Global evaluation of product performance	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
Secondary	Product safety	Global evaluation of product safety by Investigator and by the patient using Patient Global Assessment of Safety questionnaire	12 weeks