CicatrixNCT05239130

Evaluating the Performance and Safety of the Medical Device Auralya® in the Treatment of Facial Dermal Tissue Defects

A study testing Auralya in people with Cicatrix and Lipodystrophy, run by I.R.A. Istituto Ricerche Applicate S.p.A. at 1 site in Romania.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The Research Question of the present study is the following: in a population of men and women presenting facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects) will cross-linked hyaluronic acid (Auralya®) significantly decrease and / or improve their appearance, results observed after 4, 8… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Cicatrix, Lipodystrophy, Plaque
What is being tested?: Auralya
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteRomania
Study dates: 21 Mar 2022to 11 Dec 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men or women with age ≥ 18 and ≤ 65 years.
Patients with facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects), caused by both pathologies or trauma, seeking tissue augmentation and skin imperfections treatment and willing to receive Hyaluronic Acid Filler.
Patients who agree to discontinue any other dermatological treatment and procedures during the study.
Patients willing to provide signed informed consent to clinical investigation participation.
Patients able to communicate adequately with the Investigator and to comply with the requirements for the entire study.

Who cannot join

Past or current bleeding disorders.
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.

Show all 21Show fewer

Known hypersensitivity skin reaction to hyaluronic acid or hypersensitivity skin reaction to the investigational device based on intradermal test results at visit 1.
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 facial dermal tissue defects.
Facial dermal tissue defects correction procedures (e.g., botulinum toxin A injection, face lift, soft tissue augmentation, medium-depth peel, dermal photo-rejuvenation, etc.) around infraorbital region within 6 months prior to study participation.
History of hypersensitivity to local anaesthetic of amide type or HA.
History of keloid formation or hypertrophic scar on the face.
Evidence of active infection on the face.
Wound, skin disorder or infection around facial dermal tissue defects 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.).
Need to exposure to the sun, UV rays and extreme conditions of heat for at least a week after the treatment.
Need to have direct or indirect contact with quaternary ammonium salts during the study.
As with all dermal filler procedures, the product should not be used in vascular rich areas. Using the product at sites such as Glabella and nose may inadvertently be injected into the blood vessels, resulting in symptom of vessel occlusion such as colour vision deficiency and blindness.
Patients 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.

Trial locations and contacts

1 site in 1 country.

Romania1 site

SCM Dr. Rosu
Timișoara, Timiș County, 300425

Other trials in Romania

About this study

Official title: Open, Non-comparative, Multicentre Clinical Investigation to Evaluate the Performance and Safety of the Medical Device Auralya® (Hyaluronic Acid-dermal Filler) in the Treatment of Facial Dermal Tissue Defects

Read the detailed description

Auralya® action is to increase the volume of dermal-epidermal tissue based on the natural ability of hydrophilic hyaluronic acid molecules to bind to an amount of water many times greater than their weight. This allows to fill the intradermal spaces and integrate the intercellular matrix, conferring turgidity to the tissues. The cross-linking of the hyaluronic acid contained in the product has the effect of more stable and durable filling over time. These characteristics allow Auralya® to be used as a temporary filler for subcutaneous areas to correct small defects in the dermal tissue due to lipodystrophies or the presence of fibrotic tissues as scars, caused by pathologies or trauma.

Conditions: Cicatrix, Lipodystrophy, Plaque
Being tested: Auralya
Medical subject headings: Cicatrix, Lipodystrophy, Plaque, Amyloid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AuralyaDevice
Auralya® is a sterile, injectable, non-pyrogenic, re-absorbable medical product made of reticulated hyaluronic acid of non-animal origin, produced via bacterial fermentation. Auralya® is a colourless gel contained in a pre-filled, graduated, disposable, and sterile glass syringe with a Luer adapter.

Study groups in NCT05239130
Study group	Role	What they receive
Auralya 1	Experimental	Sixteen patients will be administered Auralya® 1 (Cross-linked Hyaluronic Acid) for the treatment of minor facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects). Receives: Device: Auralya
Auralya 2	Experimental	Sixteen patients will be administered Auralya® 2 (Cross-linked Hyaluronic Acid) for the treatment of medium-sized facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects). Receives: Device: Auralya
Auralya 3	Experimental	Sixteen patients will be administered Auralya® 3 (Cross-linked Hyaluronic Acid) for the treatment of major facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects). Receives: Device: Auralya

What is being measured

The primary outcome is the main question the study is designed to answer.

POSAS score assessed by Investigator and patient
To evaluate the overall performance of the medical dermal filler Auralya® in treating facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects) in terms of change in Patient and Observer Scar Assessment Scale (POSAS) score [Draaijers, 2004; van de Kar, 2005], assessed by Investigators and patients 8 weeks (56 days) after the initiation of treatment, compared to Visit 1 (day 0)
Measured: 8 weeks
POSAS score assessed by Investigator and patient
To evaluate the overall performance of the medical dermal filler Auralya® in treating facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects) in terms of change in Patient and Observer Scar Assessment Scale (POSAS) score [Draaijers, 2004; van de Kar, 2005], assessed by Investigators and patients at 4 weeks (28 days) after the initiation of treatment, compared to Visit 1 (day 0)
Measured: 4 weeks
POSAS score assessed by Investigator and patient
To evaluate the overall performance of the medical dermal filler Auralya® in treating facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects) in terms of change in Patient and Observer Scar Assessment Scale (POSAS) score [Draaijers, 2004; van de Kar, 2005], assessed by Investigators and patients at 12 weeks (84 days) after the initiation of treatment, compared to Visit 1 (day 0)
Measured: 12 weeks
Investigator Global Assessment of Performance (IGAP)
To evaluate the global performance of product assessed by Investigator through photos taken at each visit (IGAP), at week 12 (day 84), compared to Visit 1 (day 0)
Measured: 12 weeks
Adverse Event incidence
To evaluate the safety of the device through Adverse Event incidence assessed by Investigators at all visits and reported according to the current legislation
Measured: 12 weeks
Serious Adverse Event incidence
To evaluate the safety of the device through Serious Adverse Event incidence assessed by Investigators at all visits and reported according to the current legislation
Measured: 12 weeks
Adverse Device Event incidence
To evaluate the safety of the device through Adverse Device Event incidence assessed by Investigators at all visits and reported according to the current legislation
Measured: 12 weeks
Serious Adverse Device Event incidence
To evaluate the safety of the device through Serious Adverse Device Event incidence assessed by Investigators at all visits and reported according to the current legislation
Measured: 12 weeks

Secondary outcomes (4)

Global Aesthetic Improvement Scale evaluated by the patient (GAIS)
To evaluate general appearance after treatment assessed by the patient at 4, 8 and 12 weeks (28, 56 and 84 days) using the Global Aesthetic Improvement Scale (GAIS) [Kim, 2016], [Kopera, 2015 - 2018], [McCall-Perez, 2011], [Savoia, 2015]. The scale evaluates the appearance from 1 (very much improved) to 5 (worse than original condition) .
Measured: 12 weeks
Treatment satisfaction assessment by the patient
To assess the patient satisfaction at 4, 8 and 12 weeks (28, 56 and 84 days), providing their degree of satisfaction with the treatment on a four-point scale (very satisfied, satisfied, moderately satisfied, or not satisfied) [Few, 2015]
Measured: 12 weeks
Investigator Global Assessment of Safety (IGAS)
To evaluate the global safety of product assessed by Investigator (IGAS), at week 12 (day 84), compared to Visit 1 (day 0) , providing the safety on a four point scale from 4 meaning poor safety to 1 meaning very good safety.
Measured: 12 weeks
Patient Global Assessment of Safety (PGAS)
To evaluate the global safety of product assessed by the patient (PGAS), at week 12 (day 84), compared to Visit 1 (day 0), providing the safety on a four point scale from 4 meaning poor safety to 1 meaning very good safety.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Mar 202211 Dec 2022

First posted14 Feb 2022
Study start21 Mar 2022
Primary completion11 Dec 2022 (estimated)
Study completion11 Dec 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (36)Papers the sponsor has linked to this study.
Other trials for CicatrixStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: This is a multi-center, open-label, non-randomized clinical investigation
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05239130
Sponsor's protocol ID: OPIRA/0421/MD
Status last verified: Apr 2022
First submitted: 17 Jan 2022
Last updated: 25 Oct 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Almeida A, Sampaio G. Hyaluronic acid in the rejuvenation of the upper third of the face: review and update - Part 1. 2018.
Ascher B, Bayerl C, Brun P, Kestemont P, Rzany B, Poncet M, Guennoun M, Podda M. Efficacy and safety of a new hyaluronic acid dermal filler in the treatment of severe nasolabial lines - 6-month interim results of a randomized, evaluator-blinded, intra-individual comparison study. J Cosmet Dermatol. 2011 Jun;10(2):94-8. doi: 10.1111/j.1473-2165.2011.00550.x.
PubMed 21649813
Barnes LA, Marshall CD, Leavitt T, Hu MS, Moore AL, Gonzalez JG, Longaker MT, Gurtner GC. Mechanical Forces in Cutaneous Wound Healing: Emerging Therapies to Minimize Scar Formation. Adv Wound Care (New Rochelle). 2018 Feb 1;7(2):47-56. doi: 10.1089/wound.2016.0709.
PubMed 29392093
Bhatt A. Protocol deviation and violation. Perspect Clin Res. 2012 Jul;3(3):117. doi: 10.4103/2229-3485.100663. No abstract available.
PubMed 23125964
Brandt FS, Cazzaniga A. Hyaluronic acid gel fillers in the management of facial aging. Clin Interv Aging. 2008;3(1):153-9. doi: 10.2147/cia.s2135.
PubMed 18488885
Bukhari SNA, Roswandi NL, Waqas M, Habib H, Hussain F, Khan S, Sohail M, Ramli NA, Thu HE, Hussain Z. Hyaluronic acid, a promising skin rejuvenating biomedicine: A review of recent updates and pre-clinical and clinical investigations on cosmetic and nutricosmetic effects. Int J Biol Macromol. 2018 Dec;120(Pt B):1682-1695. doi: 10.1016/j.ijbiomac.2018.09.188. Epub 2018 Oct 1.
PubMed 30287361
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.
PubMed 23687448
Rippa AL, Kalabusheva EP, Vorotelyak EA. Regeneration of Dermis: Scarring and Cells Involved. Cells. 2019 Jun 18;8(6):607. doi: 10.3390/cells8060607.
PubMed 31216669
Chen WY, Abatangelo G. Functions of hyaluronan in wound repair. Wound Repair Regen. 1999 Mar-Apr;7(2):79-89. doi: 10.1046/j.1524-475x.1999.00079.x.
PubMed 10231509
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.
PubMed 25926750
Dong J, Gantz M, Goldenberg G. Efficacy and safety of new dermal fillers. Cutis. 2016 Nov;98(5):309-313.
PubMed 28040813
Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.
PubMed 15253184
Eming SA, Martin P, Tomic-Canic M. Wound repair and regeneration: mechanisms, signaling, and translation. Sci Transl Med. 2014 Dec 3;6(265):265sr6. doi: 10.1126/scitranslmed.3009337.
PubMed 25473038
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.
PubMed 25964628
Fitzgerald R, Graivier MH, Kane M, Lorenc ZP, Vleggaar D, Werschler WP, Kenkel JM. Update on facial aging. Aesthet Surg J. 2010 Jul-Aug;30 Suppl:11S-24S. doi: 10.1177/1090820X10378696.
PubMed 20844296

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Cicatrix trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open, Non-comparative, Multicentre Clinical Investigation to Evaluate the Performance and Safety of the Medical Device Auralya® (Hyaluronic Acid-dermal Filler) in the Treatment of Facial Dermal Tissue Defects
ClinicalTrials.gov ID: NCT05239130
Acronym / sponsor ID: OPIRA/0421/MD
Conditions: Cicatrix, Lipodystrophy, Plaque
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 48 participants (actual)
Lead sponsor: I.R.A. Istituto Ricerche Applicate S.p.A.Research network
Collaborators: Opera CRO, a TIGERMED Group Company
Study start: 21 Mar 2022 (actual)
Primary completion: 11 Dec 2022 (estimated)
Study completion: 11 Dec 2022 (estimated)
First posted: 14 Feb 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: This is a multi-center, open-label, non-randomized clinical investigation

Arm	Type	Receives
Auralya 1	Experimental	Device: AuralyaSixteen patients will be administered Auralya® 1 (Cross-linked Hyaluronic Acid) for the treatment of minor facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects).
Auralya 2	Experimental	Device: AuralyaSixteen patients will be administered Auralya® 2 (Cross-linked Hyaluronic Acid) for the treatment of medium-sized facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects).
Auralya 3	Experimental	Device: AuralyaSixteen patients will be administered Auralya® 3 (Cross-linked Hyaluronic Acid) for the treatment of major facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects).

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Men or women with age ≥ 18 and ≤ 65 years.
Patients with facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects), caused by both pathologies or trauma, seeking tissue augmentation and skin imperfections treatment and willing to receive Hyaluronic Acid Filler.
Patients who agree to discontinue any other dermatological treatment and procedures during the study.
Patients willing to provide signed informed consent to clinical investigation participation.
Patients able to communicate adequately with the Investigator and to comply with the requirements for the entire study.

Key exclusion criteria (21 listed)

Past or current bleeding disorders.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AuralyaAuralya® is a sterile, injectable, non-pyrogenic, re-absorbable medical product made of reticulated hyaluronic acid of non-animal origin, produced via bacterial fermentation. Auralya® is a colourless gel contained in a pre-filled, graduated, disposable, and sterile glass syringe with a Luer adapter.	Device	Auralya 1, Auralya 2, Auralya 3

Primary outcome

POSAS score assessed by Investigator and patient
Time frame: 8 weeks
To evaluate the overall performance of the medical dermal filler Auralya® in treating facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects) in terms of change in Patient and Observer Scar Assessment Scale (POSAS) score [Draaijers, 2004; van de Kar, 2005], assessed by Investigators and patients 8 weeks (56 days) after the initiation of treatment, compared to Visit 1 (day 0)
POSAS score assessed by Investigator and patient
Time frame: 4 weeks
To evaluate the overall performance of the medical dermal filler Auralya® in treating facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects) in terms of change in Patient and Observer Scar Assessment Scale (POSAS) score [Draaijers, 2004; van de Kar, 2005], assessed by Investigators and patients at 4 weeks (28 days) after the initiation of treatment, compared to Visit 1 (day 0)
POSAS score assessed by Investigator and patient
Time frame: 12 weeks
To evaluate the overall performance of the medical dermal filler Auralya® in treating facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects) in terms of change in Patient and Observer Scar Assessment Scale (POSAS) score [Draaijers, 2004; van de Kar, 2005], assessed by Investigators and patients at 12 weeks (84 days) after the initiation of treatment, compared to Visit 1 (day 0)
Investigator Global Assessment of Performance (IGAP)
Time frame: 12 weeks
To evaluate the global performance of product assessed by Investigator through photos taken at each visit (IGAP), at week 12 (day 84), compared to Visit 1 (day 0)
Adverse Event incidence
Time frame: 12 weeks
To evaluate the safety of the device through Adverse Event incidence assessed by Investigators at all visits and reported according to the current legislation
Serious Adverse Event incidence
Time frame: 12 weeks
To evaluate the safety of the device through Serious Adverse Event incidence assessed by Investigators at all visits and reported according to the current legislation
Adverse Device Event incidence
Time frame: 12 weeks
To evaluate the safety of the device through Adverse Device Event incidence assessed by Investigators at all visits and reported according to the current legislation
Serious Adverse Device Event incidence
Time frame: 12 weeks
To evaluate the safety of the device through Serious Adverse Device Event incidence assessed by Investigators at all visits and reported according to the current legislation

4 secondary outcomes

Global Aesthetic Improvement Scale evaluated by the patient (GAIS)
Time frame: 12 weeks
Treatment satisfaction assessment by the patient
Time frame: 12 weeks
Investigator Global Assessment of Safety (IGAS)
Time frame: 12 weeks
Patient Global Assessment of Safety (PGAS)
Time frame: 12 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
BackgroundAlmeida A, Sampaio G. Hyaluronic acid in the rejuvenation of the upper third of the face: review and update - Part 1. 2018.
Background: PubMed 21649813Ascher B, Bayerl C, Brun P, Kestemont P, Rzany B, Poncet M, Guennoun M, Podda M. Efficacy and safety of a new hyaluronic acid dermal filler in the treatment of severe nasolabial lines - 6-month interim results of a randomized, evaluator-blinded, intra-individual comparison study. J Cosmet Dermatol. 2011 Jun;10(2):94-8. doi: 10.1111/j.1473-2165.2011.00550.x.
Background: PubMed 29392093Barnes LA, Marshall CD, Leavitt T, Hu MS, Moore AL, Gonzalez JG, Longaker MT, Gurtner GC. Mechanical Forces in Cutaneous Wound Healing: Emerging Therapies to Minimize Scar Formation. Adv Wound Care (New Rochelle). 2018 Feb 1;7(2):47-56. doi: 10.1089/wound.2016.0709.
Background: PubMed 23125964Bhatt A. Protocol deviation and violation. Perspect Clin Res. 2012 Jul;3(3):117. doi: 10.4103/2229-3485.100663. No abstract available.
Background: PubMed 18488885Brandt FS, Cazzaniga A. Hyaluronic acid gel fillers in the management of facial aging. Clin Interv Aging. 2008;3(1):153-9. doi: 10.2147/cia.s2135.
Background: PubMed 30287361Bukhari SNA, Roswandi NL, Waqas M, Habib H, Hussain F, Khan S, Sohail M, Ramli NA, Thu HE, Hussain Z. Hyaluronic acid, a promising skin rejuvenating biomedicine: A review of recent updates and pre-clinical and clinical investigations on cosmetic and nutricosmetic effects. Int J Biol Macromol. 2018 Dec;120(Pt B):1682-1695. doi: 10.1016/j.ijbiomac.2018.09.188. Epub 2018 Oct 1.
Background: PubMed 23687448Callan 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.
Background: PubMed 31216669Rippa AL, Kalabusheva EP, Vorotelyak EA. Regeneration of Dermis: Scarring and Cells Involved. Cells. 2019 Jun 18;8(6):607. doi: 10.3390/cells8060607.
Background: PubMed 10231509Chen WY, Abatangelo G. Functions of hyaluronan in wound repair. Wound Repair Regen. 1999 Mar-Apr;7(2):79-89. doi: 10.1046/j.1524-475x.1999.00079.x.
Background: PubMed 25926750De 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.
Background: PubMed 28040813Dong J, Gantz M, Goldenberg G. Efficacy and safety of new dermal fillers. Cutis. 2016 Nov;98(5):309-313.
Background: PubMed 15253184Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mihaela Fratila principal investigator

SCM Dr. Rosu

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Auralya in people with Cicatrix and Lipodystrophy, run by I.R.A. Istituto Ricerche Applicate S.p.A. at 1 site in Romania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

POSAS score assessed by Investigator and patient (time frame: 8 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05239130, which also lists 36 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.